Cosmetic Skin Irritants

Cosmetics are complex mixtures of chemical compounds. The abundance of commercially available ingredients has created endless variety in cosmetic formulation. The cosmetic substances used in cosmetic products may be arbitrarily divided in great categories of product and or function. The principal categories of cosmetic irritants are listed in Table 2. Intolerance to some ingredients is related to symptoms of contact dermatitis and allergic dermatitis. There is not always a clear distinction...

Differences Of Untreated Asian And Caucasian Hair

Because of the differences in cross-section, we found different wet and dry tensile strengths of single hair fibers. Asian hair shows higher values than Caucasian hair. The application of a perm, bleach, or both results in decreasing tensile forces for both hair types (Fig. 3). The higher values for dry combing forces are found again for Asian hair (Fig. 4). The wet combing work shows comparable results for the untreated hair types. In addition to these results we measured the bounce of curls....

The Future Of Mousses

Although it is easy to describe the various characteristics and attributes of mousse products, it is difficult to entirely separate this technology from that of other product forms. There are obvious overlaps between mousse technology and the technologies pertinent to solutions, emulsions, and suspensions. The mousse product evolved from a combination of these overlaps as well as an appropriate type of packaging being available. The propel-lant can be considered simply as a low-boiling point...

Summary

Synthetic bisabolol and natural (-)-a-bisabolol have protective and beneficial effects, which were demonstrated by two new clinical studies. The grade of inflammation was measured with the help of a Minolta Chromameter and the a*-value was used to determine the grade of inflammation. The transepidermal water loss was used to reflect the damage of the skin barrier. The studies proved that (- )-a-bisabolol and synthetic bisabolol reduces the development of an erythema and reduce erythema set by...

Standardization

If the beneficial constituents of an extract are known, establishing specific quality standards is not difficult. It has to be assured by a suitable analytical technique that the extract contains a certain level of these active constituents. By way of an example, the antiinflammatory constituents of oat extract (Avena sativa) have recently been discovered 2 . This was a difficult task because the chemistry of oat is quite complex. The active in oat belongs to a group of compounds called...

Shampoo Additives

These are materials incorporated into a shampoo formulation to enhance its aesthetics as well as improve its performance. Thickeners comprise a broad variety of compounds that are used to increase viscosity of the formulations, modifying their consistency from viscous liquids to thick gels. Among the most frequently used are electrolytes, such as sodium chloride, alkanolamides and water-soluble cellulose derivatives, such as carboxymethylcellulose, hydroxyethylcellu-lose, carboxy vinyl polymers...

Safety

The visible color change associated with the use of artificial tanning products might suggest to some users that these products are hazardous. Based on the chemistry of DHA and its toxicological profile, it can be considered nontoxic. It reacts quickly in the stratum corneum minimizing systemic absorption. The acute toxicity of DHA was investigated for diabetics in the 1920s with their oral intake well tolerated 6 . The phosphate of DHA is found naturally as one of the intermediates in the...

Regulatory Environment

The cosmetic regulations in Japan are extensive and complex 1 . The legal classification of topically applied products is different from the United States and the European Union, where they are divided into only two categories drugs and cosmetics. In Japan, there are additional regulations covering cosmetic products with pharmacological action, called quasidrugs, which are ranked between cosmetics and drugs 2 . Under the Pharmaceutical Affairs Law, cosmetics, as well as drugs and quasidrugs,...

References

Death from skin cancer among the elderly epidemiological patterns. Arch Dermatol 1997 133 1207-1209. 2. Yaar M, Gilchrest BA. Aging versus photoaging postulated mechanisms and effectors. J Invest Dermatol Symp Proc 1998 3 47-51. 3. Naylor MF, Farmer KC. The case for sunscreens a review of their use in preventing actinic damage and neoplasia. Arch Dermatol 1997 133 1146-1154. 4. Gurish MF, Roberts LK, Krueger GG, et al. The effect of various sunscreen agents on skin damage and the...

Others

Some other vitamins and vitamin precursors used in cosmetic products are biotin, niacinamide, vitamin D, vitamin B6, beta-carotene, and, in a few products, vitamin K. For all these substances there exists a rationale for their use in cosmetics but there are either no studies or insufficient studies available that prove their efficacy when topically applied. Systemic use of 2.5 mg biotin per day has shown good effect on brittle nails and has improved hair quality 46-49 . As it has good effect on...

Other Agents

Various systemic drugs and natural products may be used as protective agents, such as chloroquine, indomethacin, vitamin C and E, fish oil, and green tea, etc. Topical agents include azelaic acid and melawhite except where previously described 38 . Recently, Kobayashi et al. 39 reported that neoagarobiose could be useful as a novel whitening agent as it has shown moisturizing and whitening effects with low cytotoxicity. Ando et al. 40 evaluated the effects of unsaturated fatty acids on...

Introduction

The expression barrier cream'' is used most often to indicate those creams that are used in the context of prevention of irritant contact dermatitis (ICD) 1 . The use of this type of product, however, is much broader than the medical care circuit (diagnosed patients by dermatologists, general practitioners, or other healthcare professionals), and in fact the major sales of barrier creams is in the segments of skincare and occupational use. In these segments there is quite some mix-up between...

Indications

Even with recent improvement in DHA formulations, the color achieved remains dependent on skin type. Individuals of medium complexion with skin phototypes II or III 14 , as opposed to those who are lighter or darker, will obtain a more pleasing color. Individuals with underlying golden skin tones will achieve better results than individuals with rosy, sallow, or olive complexions. Older consumers with roughened, hyperkeratotic skin or mottled pigmentation with freckling may be less pleased with...

Conclusions

Sensitive skin represents a widespread condition of susceptibility to exogenous factors. The reason why some subjects react with subjective symptoms like itching, burning, stinging, prickling, or tingling is unclear. However, a correlation of increased reactivity in subjects with a history of dermatitis and the association of increased reactivity with skin type I has been reported. Noninvasive evaluation of sensitive skin may successfully predict individual susceptibility to cosmetic-related...

Additives

Soap manufacturers have developed a variety of formulation approaches to deliver products that better meet the consumer needs of today. Even though the base soap composition has not changed, consumer needs are met by the inclusion of various additives. As with any other product, the stability (physical and chemical state) of the soap-base-additive or even additive-additive mix must be considered during the formulation. There are a variety of additives that are formulated into soap bars to...

Hair Soiling and Soil Removal

In the course of its residence on the scalp, hair is exposed to a variety of events that contribute to its soiling. Among them are the innate processes of scalp desquamation, sweating, and sebum secretion, which are supplemented by deposition of extraneous substances arising either from environmental pollution (dust and other airborne contaminants) or from hair-grooming preparations, such as oils, waxes, hair spray, and mousse residues. Of all these, sebum, because of to its steady...

Soap Raw Materials Fats and Oils

The naturally occurring fats and oils used in soap making are glycerides with three fatty acid groups randomly esterified with glycerol (trihydroxy alcohol). The difference between fats and oils is merely one of their physical states fats are solids and oils are liquids. Fats and oils typically comprise both saturated and unsaturated fatty acid molecules containing between 7 and 21 carbons randomly distributed on the glycerol backbone. Overall, the reaction of caustic (lye) with triglycerides...

Ionic Surfactants Anionic Surfactants

In aqueous solution, anionic surfactants form a negatively charged ion provided the composition pH is neutral to alkaline. The ionized moiety can be a carboxylate, sulfate, sulfonate or phosphate. Among most frequently used surfactants in skin care products, the alkyl sulfates and alkyl ethoxylated sulfates can be mentioned for their high foaming capacity. Anionics are generally used in association with other surfactants (nonionics or amphoterics), which bring improvements in the skin...

Formulations Regular Soaps Combars And Syndets

Soap bars are formulated with a combination of longer carbon chain length fats (tallow, palm oil, palm stearin) and shorter carbon chain length oils (palm kernel oil, coconut oil). Common nomenclature for bar soaps is the ratio of the longer carbon chain length fat to the shorter carbon chain length oil. For example, a bar containing 80 tallow and 20 coconut oil as its soap base would be referred to as an ''80 20'' soap bar. Ratios used typically range from 90 10 to 60 40. The higher coco or...

Strontium Mechanism Of Action

Burning Strontium Nitrate

Simple salts of the element strontium can effectively suppress sensory irritation caused by chemically and biologically unrelated chemical irritants over a pH range of 0.6 to 12. Because strontium acts within seconds after application, it is likely that it is acting directly on the type-C chemical sensors that transmit stinging, burning, and itching. In animal studies, strontium salts have been reported to directly suppress neuronal depolarization 25,26 . In vivo, strontium is a divalent ion...

Categories Of Claims

However they are used (e.g., label, television, or magazine advertising), claims related to cosmetic products can be subdivided into several categories. Table 1 summarizes these categories and provides some examples for each. As previously explained, all claims are not applicable everywhere in the world for cosmetic products and can fall under different regulations in some places. Claims related to physical and chemical properties Claims related to the test procedure or to an endorsement...

Acute ICD

Acute ICD is caused by contact to a potent irritant. Substances that cause necrosis are called corrosive and include acids and alkaline solutions. Contact is often accidental at the workplace. Cosmetics are unlikely to cause this type of ICD because they do not contain primary irritants in sufficient concentrations. Symptoms and clinical signs of acute ICD develop with a short delay of minutes to hours after exposure, depending on the type of irritant, concentration, and intensity of contact....

Backing Film

The backing film is one of the three layers of a matrix patch. It is the layer that is apparent after the adhesion of the patch on the specific site of the skin. Its main role is to protect the adhesive layer from the influence of external factors it also provides such characteristics as flexibility, occlusivity, breathability, and printability. Several materials have been used as backing films. The selection of a specific film for use in a cosmetic patch may depend on the following factors...

Neurodermatitis

Neurodermatitis, also called atopic dermatitis, is a skin disease that may occur at a very early age. It can be identified by the so-called milk crust on the reddened, damp skin of the head and cheeks of the newborn. As the first indication of an outbreak of neurodermati-tis, the milk crust often provides the starting point for other skin disorders. The skin becomes cracked and transparent, and the permeability increases. Once the skin is damaged, the risk of infection is higher. The skin...

Definition of Cosmetics

Bailey, and Allen R. Halper Office of Cosmetics and Colors, Center for Food Safety and Applied Nutrition (CFSAN), U.S. Food and Drug Administration, Washington, D.C. Cosmetics are a category of consumer products marketed worldwide, the purpose and functions of which are universal to people of all cultures. The 1998 global cosmetics and toiletries market was valued at 125.7 billion 1 , including skincare, fragrance, haircare, personal hygiene, and makeup products. In...

Sensory Testing

Hill Top Research, Inc., Scottsdale, Arizona Although most individuals don't realize it, they conduct sensory tests on a daily basis. Throughout the day, personal sensory assessments are made about the taste acceptability or liking for different foods for many different attributes. Individuals evaluate haircare products for various properties, not only while using the product but also for feel of the hair after shampooing. Every time a cosmetic product, moisturizer, or any other skincare...

Why Is Testing Being Done

Why is testing necessary Are you concerned with product appearance or do you want to determine if specific performance characteristics change over time The reasons for doing the tests will determine what kind of tests are required. Therefore it is critically important to approach this testing with a scientific mind set and to have a clearly defined hypothesis to be tested. Take, for example, the case of a skin lotion formula that develops an unpleasant odor. The reason for the test is to...

Where Will Test Samples Be Stored and How Many Are Necessary

Ideally, you could gain information on formula stability by performing exhaustive tests on every variable involved in every formulation you work with, but this is not always feasible, because proper testing requires a significant commitment of time and resources. Therefore, most companies have standardized test procedures for the storage of stability samples which depend on the objective of the study. Such procedures involve evaluations of samples stored at a variety of conditions and include...

What Is Soap

Soap is generally defined as an alkali salt of a long-chain fatty acid. When a fat or oil is saponified, the sodium or potassium salt formed from the long-chain fatty acids is called a soap. The term ''soap'' refers to a group of neutralized long-chain carboxylic acids, which result from two primary ingredients an alkali and a triglyceride (fat or oil). The chain length of the aliphatic group is typically between 7 and 21 carbons with one carbox-ylate carbon, yielding a molecule containing 8 to...

What Is Being Tested

Another important factor to understand is the status of the formula being tested. Is it a developmental prototype or the final production material Consider a situation, as in the example provided above, where you are primarily concerned with the change in product viscosity. Furthermore, consider that the final color and fragrance of the product have not yet been firmly established, although there are several candidates under evaluation. You could prepare samples with every possible color...

Wear Rate UseUp

The measurement of how long a bar lasts under normal use conditions is an important attribute to the consumer perceived value. The use-up rate is measured by first weighing the soap bar and then washing the bar for a set number and length of times (for example, 25 washings for 10 sec each). The bar is then dried and weighed again and the use-up or wear rate is reported as the percent weight loss. Soap bar shape and size impact the reported use-up rate. The use-up rate measurement must be...

Washing And Exaggerated Immersion Tests

The aim of these tests is to identify a subpopulation with an increased tendency to produce a skin response. In the washing test 27 , subjects are asked to wash their face with a specific soap or detergent. After washing, individual sensation for tightness, burning, itching, and stinging is evaluated using a point scale previously determined. The exaggerated immersion test is based on soaking the hands and forearms of the subjects in a solution of anionic surfactants (such as 0.35 paraffine...

Vitamins

Many vitamins, including vitamins A, C, D, and E, are vital in normal metabolic processes, and clinical skin changes resulting from their deficiencies were identified in many cases even in the 1800s. Some of these changes have been shown to be secondary to abnormal keratinization, altered differentiation, or impaired collagen synthesis. Nevertheless, it has been difficult to scientifically confirm cosmeceutical activity or utility of these vitamins under the conditions of normal nutritional...

Vitamin C

Ascorbic acid or vitamin C is one of the most important water soluble antioxidants and present in high amounts in the skin. While most species are able to produce ascorbic acid, humans lack the enzymes necessary for its synthesis. Deficiency in ascorbic acid causes scurvy, a disease already described in the ancient writings of the Greeks 28 . Apart from the pure antioxidant function ascorbic acid is an essential co-factor for different enzymes. The antioxidant capacity of vitamin C is related...

Vitamin A

Vitamin A (Fig. 2) and its derivatives belong to a large class of structurally related compounds, the retinoids. The term vitamin A is generically used for all derivatives of 0-ionone that possess the biological activity of all-trans retinol or are closely related to it. The biological activities of the vitamin A derivatives are expressed in IU (international units.) One IU corresponds to 0.3 g retinol, 0.34 g vitamin A acetate, and 0.55 g vitamin A palmitate. Vitamin A is best known for its...

Vesicular Systemsliposomes And Niosomes Definition Description

Vesicular systems encompass a number of delivery technologies, including liposomes and niosomes. Both of these systems employ a ''vessel'' to contain active ingredients within a formula and to provide controlled delivery of these ingredients. Nacht defines controlled delivery as a ''system that would result in a predictable rate of delivery of its active ingredients to the skin'' 1 . Liposomes are a classic example of this technology, in which phospholipids are used to create lipid ''capsules''...

Vehicle Influence On Percutaneous Absorption

A cosmetic can be a single ingredient or a mixture of chemicals in a vehicle. The vehicle can have a great effect on skin absorption of the chemical(s). Lidocaine was applied to human skin in an in vitro absorption study. Figure 5 shows receptor fluid (circulating under the skin to collect absorbed lidocaine) accumulation with time. Initially the vehicle had a great influence on the partitioning of lidocaine into the skin. With time, the influence of the vehicle decreased and lidocaine...

V

Monoesters disodium salts are the most common sulfosuccinates used in cosmetic applications. Monoesters of alkanolamines (sulfosuccinamates) are milder than monoesters of fatty alcohols (sulfosuccinates). Monoesters derived from ethoxylated alcohols or alkanolamides are extensively used in personal products and especially in shampoos they are known for their mildness and skin-irritation reduction when used in association with other anionic surfactants. Sulfo Fatty Acid Esters. These surfactants...

United Kingdom

Directive implemented June 1996, nonconform products accepted until January 1, 1999. Notification for manufacturing site and importation per categories perfumes, decorative cosmetics, skincare, haircare, and toiletries. Animal testing forbidden from 1998, but the delay will be regulated soon. Qualification Safety certificates must be signed by pharmacist or a physician holding a United Kingdom diploma. Poison Information Center via competent authorities Consumer Safety Unit, Department of Trade...

Types And Configuration

There are several ways to describe and categorize a cosmetic patch. It can be characterized from the patch form (e.g., matrix, reservoir), the application purpose and the expected result (e.g., moisturising, anti-wrinkle), the type of its structural materials (synthetic, natural, hybrid), the duration of application (e.g., overnight patch, half-hour patch). Cosmetic marketing is always more inventive in finding attractive terms to characterize a cosmetic product, but even scientifically there...

TIME hours

Figure 5 Release of BPO dispersed in vehicle ( ) abd BPO entrapped in porous microspheres and dispersed in vehicle ( ). Results are the average of two determinations. Formulations applied to silastic membrane. Receiving fluid 1 1 mixture of water and acetone. (From Ref. Cumulative 14-day irritancy scores in human volunteers are shown in Figure 6 and Table 1. In this study involving 29 patients, total irritaancy of four commercial products, three containing free BPO and one containing entrapped...

Thiol Antioxidants

Thiols share an oxidizable sulphhydryl (SH) group. Glutathione (GSH) is a tripeptide (Fig. 3) whose SH group at the cysteine can be oxidized, forming a disulphide (GSSG) with another GSH molecule. Physiologically, more than 90 of the GSH is in the reduced form. Glutathione peroxidases use GSH oxidation to reduce H2O2 and other water soluble peroxides. The synthesis of GSH by the human cell is stimulated by N-acetyl-cysteine (NAC), which is hydrolyzed to cysteine intracellularly. Moreover NAC...

Thickeners

Water and oils form the base fluids in which most personal-care and cosmetic products are formulated. These base fluids are generally classed as viscous or Newtonian fluids in that they possess a characteristic viscosity that is independent of the imposed rate of deformation. Newtonian fluids are also viewed as ideal fluids, in that they flow readily when subjected to very low deformations. Non-Newtonian fluids on the other hand possess viscosities that are dependent on the rate of deformation...

The Teeth And Oral Environment

Like all mammals, humans generally have two sets of teeth during a lifetime. The first set, known as deciduous, primary, or ''milk'' teeth, begins to appear in infants between the age of 5 and 9 months. All 20 of these ''baby'' teeth are generally in place by age 21 2 years. The second set, or permanent teeth, forms within the gums during the period from infancy to puberty. These teeth, also known as succedaneous teeth, begin to erupt at around age 5, displacing the deciduous set as they...

The Normal Nail

Free University of Brussels and H pital Saint-Pierre, Brussels, Belgium The nail plate, also abbreviated to ''nail,'' is a hard keratin plate, slightly convex in the longitudinal and transverse axes. It is set in the soft tissues of the dorsal digital extremity, from which it is separated by the periungual grooves (proximal, lateral, and distal) (Fig. 1) 1,2 . It stems from the nail matrix located in the proximal part of the nail apparatus. The nail plate and matrix are partly covered by a skin...

The Microscopic Structure of the Epidermis and Its Derivatives

University of California at San Francisco School of Medicine, San Francisco, California A general review of the microscopic structure of the epidermis and those epidermal derivatives that are distributed widely over the skin and, therefore, may be of interest in considerations of mechanisms of percutaneous absorption, will be presented here. Both light and electron microscopic information will be discussed in order to give an integrated brief summary of the basic morphological picture. The...

The Laws Of The Member States Relating To Cosmetic Products And The 6th Amendment

The Council of the European Communities in regard to the Treaty establishing the European Economic Community (today, the European Union EU ) and in particular Article 100 thereof has decided to harmonize legislation in the EU 1,2 . The Directive gives a clear definition of cosmetic products ''Any substance or preparation intended to be placed in contact with the various external parts of the human body or with the teeth and and the mucous membranes of the oral cavity, with a view exclusively or...

The Ideal Antisensory Antiirritant

The idea antisensory anti-irritant would effectively inhibit stinging, burning, and itching caused by a broad range of acidic, neutral, and basic chemical irritants by reducing the sensitivity of type-C nociceptors. In contrast, it would not inhibit the warning symptom of pain mediated by A-delta nerves, nor would it affect other nerve sensors that mediate tactile, temperature, or vibratory sensations. Since most cosmetic-induced sensory irritation occurs within several minutes after...

The Future Of Encapsulation

What can we expect from encapsulation in the future Trying to predict what the future will be is not easy. When one addresses future developments in the field of encapsulation, one has to realize that, at present time, application-oriented research is mainly focused to solve problems. If the number of published articles on encapsulation (liposomes, nanopar-ticles, microparticles, microemulsions, multiple emulsions, and nanoemulsions) under the heading of drug therapy is a reliable indicator of...

The Development Of Baby Skin

The development of skin usually begins 7 to 8 days after fertilization, during which an outer blastodermic layer, the ectoderm, is formed. During the embryonic phase of development, two layers evolve from the ectoderm, the underlying basal layer from which the uppermost skin layer the epidermis and the cutaneous appendages develop, along with the periderm, which faces the fetal cavity. When the epidermis is keratinized between week 22 and 24 of pregnancy, the periderm separates itself from most...

The Antioxidant Network

When an antioxidant reacts with an oxidant, it is converted to a form that no longer functions as an antioxidant, and is said to be consumed. In order for the oxidized product to function again, it needs to be recycled to its native form. The antioxidant network describes the ability of the antioxidants to recycle and regenerate oxidized forms of each other thereby providing extra levels of protection (Fig. 5). Thus the process is synergistic the net antioxidant protection is always greater...

Tests For Sensitive Skin

Recently, because no visible clinical signs of irritation are detected in sensitive skin, new methods of sensory testing have been increasingly used to provide definite information. QUANTITATION OF CUTANEOUS THERMAL SENSATION 2 The superficial skin layer includes sensory nerve fibers connected to specialized receptors such as corpuscles or naked nerve endings. A Beta fibers, myelinated (conduction velocity 2 of 2-30m sec), mediate the touch, vibration, and pressure sensation. A Delta fibers,...

Test Methods

Because of the fact that BR products as such are an upcoming category of products, there is not an established view on test methods that should be used to identify and label such products. However, based on the arguments given in this chapter, test methods using mice where recovery of TEWL is studied following breaking of the skin barrier with acetone 26,32 are proposed, whereas human volunteer models using treatment instead of pretreat-ment schedules following damaging the skin with irritants...

Test Conditions and Validations

The challenge test consists in an artificial contamination of the tested sample and counting of the survivors during a period of 4 weeks maximum. Even if several preservative efficacy tests exist as described in the USP23 65 , the Japanese Pharmacopeia 66 , or the CTFA test 67-74 , the general conditions of the test described here are those of the European Pharmacopeia 43 , adapted from a Federation Internationale Pharmaceutique (FIP) working party publication 44 . Several points, such as...

Target Profile

First, a clear target profile of the product must be defined. This includes the following 1. Site of application. Depending on the site, certain forms may not be adequate, e.g., a w o cream is not at all suitable for application on hair. 2. Area of application. A sticky, greasy cream cannot be applied on the whole body surface. 3. Target site. For example, the uppermost layer of stratum corneum or viable epidermis. 4. Sensory properties. For example, foaming shampoo or a light, smooth,...

Tamper Resistant Packaging

The FDA is given the authority under Sections 601 (a) and (c) and 701 (a) of the FD& C Act to issue package security requirements for cosmetics. Requirements for tamper-resis- tant packaging for cosmetic liquid oral hygiene products (e.g., mouthwashes and breath fresheners) and all cosmetic vaginal products (e.g., douches and tablets) were promulgated at 21 CFR 700.25. Details about such packaging is found in the FDA's Cosmetics Handbook 30 and at the FDA website, http www.fda.gov.

Suspending Agents

The storage stability of personal care formulations such as emulsions, suspensions and foams is of prime importance to formulators. Here again, rheological additives have been used widely to prevent sedimentation of solid particulates, prevent coalescence in emulsions, and halt collapse of foams. Rheological substances can impart suspending power to the base fluid. The polymer's yield stress or high viscosity at low shear rates are both used for this purpose. Fluids that possess a yield stress...

Surfactanttype Skin Cleansers

Main surfactants used for surfactant-type skin cleansers are listed in Table 2. Soaps are used as a primary surfactant for solid bar cleansers and paste-type cleansers. Sodium soaps are commonly used for solid bars and potassium soaps are mainly for paste-type cleansers or shaving foams. Opaque soft bar is made from triethanolamine soap as gentle facial cleanser. Soaps have excellent lathering properties and superior detergency but some deposit in hard water and cause skin tightness. Additional...

Surfactants

Amphoteric surfactants are amino acid derivatives their net charge varies with the pH in solution (Table 7). At pH below the isoelectric point they are positively charged in aqueous polyhydric alcohol esters sucrose esters methyl glucose esters acyl amino acids and salts acyl peptides sulfonic acids and salts sulfosuccinates sucrose laurate or cocoate PEG-120 methyl glucose dioleate PEG-80 methyl glucose laurate alkyl polyglucosides cocodiethanolamide cocamidopropyl betaine olivamidopropyl...

Sunscreen Activity

In the United States, the FDA Tentative Final Over-the-Counter Monograph on Sunscreens (Fed Reg. 1993) lists DHA as an approved sunscreen ingredient when used sequentially with lawsone (2-hydroxy-1, 4-napthoquinone). The European Economic Community Directive does not list DHA as a permitted UV filter. DHA itself has at most a modest effect on SPF 12 , providing perhaps SPF 3 or 4 protection. The brown color obtained on the skin does absorb in the low end of the visible spectrum with overlap...

Substantiation Of Antiwrinkle Claims Clinical Methodologies

Adequate methodologies of many and varied types now exist to accurately, precisely, reproducibly, and validly examine and quantitate the effects of products on wrinkles 4 . Consumers can judge for themselves if a product meets their needs in wrinkle effacement and, even if objective proof of efficacy is lacking, this positive perception is sometimes sufficient. There is a human tendency to estimate the age of other adults primarily by casual estimate of the degree of wrinkling of the skin of...

Styling Products

Whereas most of the styling needs of short hair are satisfactorily met by a good haircut, those with longer hair require more effort which is, however, well rewarded by the diversity of styles that can be imparted. The underlying principle of all styling processes is hair setting and a few comments on the subject seems appropriate. Hair fibers are flexible and elastic, and when dry bounce back immediately to their original configuration (straight or curly) when bent, extended, or twisted. On...

Styling Aids

As the name implies, the role of these products are first to facilitate styling the hair and second to keep it in a newly styled shape. Three general product forms represent this category styling gels, mousses, and styling sprays. Most of the formulations are based on synthetic film-forming polymers and contain a variety of additives to improve film properties and performance. Thus, phtalates and glycols are used as plasticizers. Lanolin derivatives and silicones are added to improve feel and...

Strontium Safety

Strontium is the eighth most abundant element in sea water and is found in many foods, especially green leafy vegetables. Average human consumption of strontium in food is estimated to be 0.8 mg to 5 mg a day. Studies in animals and humans show that it is remarkably nontoxic, and in some studies it is estimated to be as safe as calcium. Percutaneous absorption studies of strontium salts indicate that predicted absorption of topically applied strontium salts is far less than would be typically...

Strategy For Clinical Studies In Oralcare Products

Preclinical Evaluation Pilot Studies Controlled Studies Field Trials To document the effectiveness of oral products against dental diseases, the strategy for clinical studies is outlined in the above chart. The preclinical studies include laboratory and animal tests. For example, for fluoride efficacy a test would include fluoride uptake in teeth or hydroxyapatite, reduction in enamel solubility following fluoride treatment, followed by an acid challenge. The effectiveness in rats include the...

Steps To Percutaneous Absorption

A cosmetic that comes in contact with human skin will be absorbed into and through the skin. The components of the cosmetic will respond to the chemical and physical laws of nature, which direct the absorption process. Examples of this are solubility, partition coefficients, and molecular weight. The skin presents a barrier, both physical structure and chemical composition. A cosmetic component will transverse from a lipophilic stratum corneum to a more progressively hydrophilic epidermis,...

Statutory Controls on Cosmetics

The FD& C Act not only defines the term ''cosmetic,'' but sets forth the basic requirement that cosmetic products introduced into interstate commerce within the United States must be safe for their intended use and properly labeled. The act accomplishes this by explicitly prohibiting the adulteration or misbranding of cosmetics, and the introduction into, or receipt in, interstate commerce of ''adulterated'' or ''misbranded'' cosmetics (see FD& C Act, Sections 601 and 602, respectively).

Static Measurements

The tests are conducted on the forearm of healthy subjects and allow a randomized side-to-side comparison of test products with a placebo or vehicle, a known active product, and untreated control skin. Four to six products may be simultaneously tested. The products are applied at the rate of 2 mg cm2. Two different experimental designs may be used. 1. The test products are left in place for 1 hour (or another suitable duration, e.g., 3 h 14 ). Measurements are conducted at different times...

Stability ConsiderationsI

Since emulsions represent a mixture of two or more materials that are not miscible in each other, they are, according to the second law of thermodynamics, inherently unstable. This means that eventually the two phases will separate. The degree and speed of instabil ity are quite variable. For example, a mixture of mineral oil and water when shaken will form a macroemulsion, which immediately separates upon standing. Other emulsions can remain stable for years, but eventually all emulsions will...

Stability Considerations

Microcapsules are somewhat fragile physically and care must be taken to avoid premature rupture and release of the contents. Excessive temperature should be avoided by adding microencapsulated ingredients late in the manufacturing process. Likewise, refrain from formulating with materials that may act as solvents on the capsules walls. Finally, avoid high-shear processing, such as milling and homogenizing, which can physically disrupt the capsules. Additional techniques for enhancing the...

Specific Considerations Related to Development of Particular Formula Types

The process of stability testing a product is closely tied to the process of creating the formulation. As you develop formulations, you should always screen stability samples early in the process to make sure that your efforts are headed in the direction that will lead to a stable product. Every formula will have slightly different stability testing requirements, but for the sake of this discussion, we will give primary consideration to the types of cosmetic delivery systems detailed in this...

Specialty Shampoos

Baby shampoos place stringent requirements for nonirritancy of the scalp and eye. The majority of products are based on amphoteric detergent systems. Thus, derivatives of imidazoline, betaine, and sulfobetaine are usually combined with nonionic surfactants of the polyoxyethylated alcohol esters class to procure sting-free formulations. Medicated dandruff shampoos are designed to lessen and alleviate the excessive desquamation of the scalp via inclusion of specific ingredients. These include...

Spain

The Directive is implemented since the end of 1998 into a Royal Decrete. Notification to be made at the level of the ''provinces'' who in turn mails a copy to the Direction General de Farmacia y Productos Sanitarios (DGFPS). Labelling must be understandable to Spanish consumers. Qualification of the responsible person university degree or equivalent. The information related to poisoning are to be given in urgency to the DGFPS who informs the National Institute for Toxicology (Mahadagonda)....

Sources of Contamination

These can be divided into three groups 11,28,31,32 1. The microbiological quality of raw materials, including water s 2. The manufacturing process and J 3. The galenical form (which is made with vegetable and or animal extracts) of -c the product. Microbiological Quality of Raw Materials, Including Water Their quality depends upon their origin. Raw materials from animal or vegetable origin can be heavily contaminated with 106 or even more organisms per gram or milliliter 3335 . Fecal bacteria...

Solventtype Skin Cleansers

Solvent-type cleansers are designed to remove oily residues from cosmetics. Normally these cleansers are applied by hand to remove oily deposits of colors or pigments from the skin, and are then wiped out with tissue or cloth. Water-oil (W O) emulsions or simple oils work satisfactorily for this purpose but leave skin oily. Thus surfactant-type cleansers are quite often applied after this treatment. The widespread trend of long-lasting cosmetics requires stronger and laborious cleansing with...

Soapmakingmanufacturing Process

The process of making soap begins with the receipt of fats and oils and ends with a soap bar pressed into a desired shape and packaged for sale. There are many unit operations involved in soap making, from distillation (glycerin recovery) to drying to pneumatic conveying. The soap-making process involves the production of neat soap (wet soap) from fats and oils. The soap then goes through drying and finishing steps in order to complete the process. There are two basic routes of commercial...

Soap Phases

The physicochemical nature of soap has been shown to be critical for the in-use properties. It is generally accepted that four distinct sodium soap crystalline phases exist. These soap phases are referred to as the beta, delta, omega, and liquid crystalline phases. Today, radiographic diffraction (XRD) is considered the simplest and most reliable method for distinguishing the different phases. The phases designate the lattice spacing between the hydrocarbon chains and are predictive of physical...

Soap Base Composition And Performance

Product performance profiles are critically dependent on the base composition selection. For example, the relatively less-soluble tallow provides for bar hardness and a dense, stable, small bubbled lather, whereas the more soluble coconut oil provides an easily generated lather consisting of large bubbles. In addition to bar hardness, color, odor, and lather considerations, the formulator must be concerned with the solubility of the soap as it impacts on the use-up and sloughing of the final...

Slough Mush

Slough or mush is the undesirable soft part of the bar that results from the hydration of a soap bar as it sits in a wet soap dish. Slough is measured by placing a pre-weighed bar in a high humidity chamber for a fixed period of time, then removing the soft part of the bar and allowing the soap bar to dry. The weight taken before and after determine the slough or mush measured as the percent weight loss. Syndet bars tend to have high slough relative to regular soaps. High humidity conditions...

Skin Irritation Testing Our Experience

As previously indicated, development of in vitro methods to assess skin irritation is complicated by the fact that skin irritation encompasses a range of clinical responses from near corrosive at one extreme to very mild (perhaps sensory only) skin responses at the other. Hence, we believe that test methods and prediction models will need to be optimized for different categories of test materials or formulations and for anticipated ranges of irritation severity. That is the approach we have...

Skin Cleansing And Decontamination

Although decontamination of a chemical from the skin is commonly performed by washing with soap and water (because it is largely assumed that washing will remove the chemical), recent evidence suggests that the skin and the body are often unknowingly subjected to enhanced penetration and systemic absorption toxicity because the decontamination procedure does not work or may actually enhance absorption 9 . Figure 6 Distribution of lidocaine in human epidermis and dermis. Formulation determines...

Situations That Require Stability Testing

A good chemist should have an understanding of factors that are critical to product stability, so that appropriate testing can be conducted when necessary. Situations in which stability testing is generally necessary include but are not limited to the following situations consideration of a new formulation, qualification of new raw materials, evaluation of new manufacturing processes, and testing of different packaging components. As you will see, stability testing is not a finite, one-time...

Siloxane Backbone

The prime role of the siloxane backbone is to present the available methyl groups to their best advantage and it does this by virtue of its unique flexibility. In most hydrocarbons, the bond angles are very fixed and steric packing considerations often prevent the available methyls from adopting lowest surface energy orientations. In silicones, the Si O bond length is significantly longer and the Si O Si bond angle flatter than comparable C C and C O bonds resulting in a very low barrier to...

Self Regulation

As the cosmetic industry in the United States has grown and matured, the regulatory paradigm for cosmetics in the United States has evolved from a program based on the 1938 FD& C Act and lacking Federal pre-market approval authority into a leveraged program of industry ''self-regulation,'' with shared roles played by the FDA's other stakeholders, particularly the cosmetic industry trade associations and consumer advocacy groups. Programs that support industry self-regulation have been...

Self Perception of Skin Irritations

Generally when a finished cosmetic product comes into contact with the skin of potential consumers, it is very unlikely that observable signs of irritation are noticed in normal use. However, the overall perception of the finished product by the consumer is an important criterion for accepting its cosmetic use. In this global perception many different parameters may play a role, some independant of the potential irritancy of ingredients, such as feeling of aesthetic nature, ease of spreading on...

Selection of Vehicle Type

The type of vehicle may already be determined by the product target profile. If various types are possible, the most suitable should be selected. The following selection criteria are important function or desired effect of the vehicle on the skin, ease of formulation feasibility, and physical and chemical stability. Furthermore, solubility, polarity, saturation solubility, vehicle interactions, and formation of mesophases are subjects to be considered when dealing with development and selection...

Selected Techniques For The Study Of The Superficial Epidermis

Techniques to study scaling, dryness, transepidermal water loss, skin elasticity, color, and wrinkles, among others, are already well covered in this book and in a number of recent monographs 1-3,5-7 . In each case, techniques need to be adopted and modified relative to the precise purpose of the study protocol. Errors in the use of biophysical methods were more or less the standard some years ago when these techniques were in their infancy, but nowadays the state of the art is to develop,...

Scope

This chapter discusses the Federal regulatory requirements for the marketing of cosmetics in the United States, under the laws administered by the U.S. Food and Drug Administration (FDA). Federal control of cosmetics is a complex and shared responsibility, and, although this chapter focuses on the FDA's regulation of cosmetic products and their labeling, it also must take note of the overlapping jurisdictions of its sister agencies, the U.S. Federal Trade Commission (FTC), the U.S. Consumer...

Safety and Regulatory Issues

All aerosol hairsprays, whether containing hydrocarbon or carbon dioxide propellant, are classified as flammable by virtue of their flame propagative properties. The same is true Poly(vinyl methyl ether)-maleic anhy- 5.0 Octylacrylamine acrylates butyl amino 3.5 of pump sprays on account of their high alcohol content. Appropriate warnings should be displayed on the package informing of potential eye irritancy of the product. Federal regulation in 1978 that banned the use of chlorofluorocarbons...

Results Of Study 1 Healing Power Of Synthetic Bisabolol

Figure 8 shows the result of the TEWL measurements. The application of five test products (Fig. 5) after SLS exposure reduced TEWL in shorter time (after 24 h and 48 h) in comparison with the untreated area (p < 0.05). After 120 hours there was no difference between the six test areas. Neither synthetic bisabolol nor natural (-)-a-bisabolol influenced the repair of skin barrier. The measurement of the redness values shows (Fig. 7) that the inflammation was reduced faster (72 h and 120 h) in a...

Representative Results Photodamaged Skin with Topical Tretinoin

Computerized image analysis of silicone rubber impressions of the skin surface has been used to document the effects of topically applied tretinoin cream on photodamaged facial skin in several multicenter clinical trials 6, 12-15 . Although coarse wrinkles have been diminished, it is clear that the primary effect is on superficial, fine lines, as shown in Figure 4. Figure 4 Representative silicone rubber impressions from the crow's foot region of a patient before and after 6 months of treatment...

Regulatory Issues

As always happens with new forms, there is some confusion regarding the regulatory status of cosmetic patches. The main reason is that cosmetic patches are not included, for the time being, in the approved forms of cosmetic preparations. Considering the Directive 76 768 EEC, August 1993, which is the official regulation of cosmetic products in the European Union, a cosmetic product ''shall mean any substance or preparation intended to be placed in contact with the various external parts of the...

Regulatory Controls on Cosmetics

Cosmetics marketed in the United States, whether manufactured domestically or imported from abroad, must be in compliance with the provisions of the FD& C Act, the FPLA, and the regulations published under the authority of these laws. Yet, cosmetics are arguably the least regulated category of articles subject to the jurisdiction of the FD& C Act 16 . There is no premarket approval requirement for cosmetic products or their constituent ingredients under the law. Other than color additives...

Regulations United States

Sunscreen products in the United States are regulated by the FDA as over-the-counter drugs. The Final Monograph for Sunscreen Drug Products for Over-the-Counter Human Use was recently issued (64 Fed. Reg. 1999 64 27,666-27,693), establishing the conditions for safety, efficacy, and labeling of these products. The number of allowable sunscreen ingredients has been reduced (Table 1), reflecting the lack of interest in some of the ingredients in previously issued tentative monographs. Avobenzone...

Regional Requirements

Although all over the world the motivation exists to protect the consumer against misleading claims, the current situation is quite different between Europe, the United States, and Japan regarding claim substantiation requirements and the limit of definitions of a cosmetic product. This latter point has been discussed in previous sections (see Part 7 of this book). Specific regulations are summarized hereafter. The U.S. federal law does not require premarketing proof of claims but prohibits...

Referencesg

An overview of worldwide regulatory programs. In Estrin NF, ed. 'C The Cosmetic Industry Scientific and Regulatory Foundations. New York Marcel Dekker, 1984 133-159. 4 2. Vermeer BJ, Gilchrest BA. Cosmeceuticals Proposal for rational definition, evaluation, and regulation. Arch Dermatol 1996 132 337-340. q 3. Editorial supervision by Pharmaceuticals and Cosmetics Division, Pharmaceutical Affairs Bureau, Ministry of Health and Welfare. Guide to Quasi-drug and Cosmetic...

Raw Material Substitution

Often it becomes necessary to substitute one raw material for another similar material. This frequently occurs because a supplier discontinues one of the raw materials used in your formula. In exchange, a different, yet supposedly ''identical,'' material may be offered. Depending on the chemistry of the materials involved, there is no way to anticipate if such a change will affect formula stability. Therefore, in such situations you must con duct testing to ensure your formula will remain...

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Alkyl arn i dop ropy 1 hydrox ysultai n e Because of their ability to improve the skin tolerance against irritating anionic surfactants, and also because of their high price, betaines are usually used in association with other surfactants. Betaines are especially suitable in personal-care applications (e.g., shampoos, foam baths, liquid soaps, shower gels), fabric handwash products, and dishwashing products. These surfactants can be considered as cationic or nonionic depending on the degree of...

Quasidrugs

In the Pharmaceutical Affairs Law, quasidrugs are defined as articles having ''fixed purpose of use'' and ''mild action on the body,'' or similar articles designated by the Minister of Health and Welfare. Most of the products in this category are what we call ''pseudo-drugs'' or ''cosmeceuticals,'' a current definition of which would be ''those products that will achieve cosmetic results by means of some degree of physiological action'' 8 . The defined quasidrug products include mouth...

Pustulogenic Potential

Upon first using a new cosmetic, papules and pustules are sometimes observed after a few days. To the consumer this is acne, although this type of papulopustular reaction may be a form of follicular irritation. Certainly, as Mills and Berger pointed out, it occurs more quickly than can be accounted for by the formation of hyperkeratotic plugs and its sequalae 7 . Thus, Mills and Berger suggested that pustulogenic potential the ability to cause inflammatory lesions should be differentiated from...