Cosmetics Preparation FE 01 PDF

Cosmetics Preparation FE 01 Ass. Prof. Lamia Heikal PharmD Clinical –Level 3 2024-2025  Resources Internet sites FDA: www.fda.gov Skin care forum. www.scf.com Skin Therapy Letter. www.skintherapyletter.com Happi. www.happi.com Makingcosmetics.c...

Cosmetics Preparation FE 01 Ass. Prof. Lamia Heikal PharmD Clinical –Level 3 2024-2025  Resources Internet sites FDA: www.fda.gov Skin care forum. www.scf.com Skin Therapy Letter. www.skintherapyletter.com Happi. www.happi.com Makingcosmetics.com Books Consumer Information Handbook on Cosmetic Products Harry’s Cosmeticology Handbook of Nonprescription Drugs, APhA. Periodicals: International Journal of Cosmetic Science Journal of Cosmetic Science Cosmetic ingredients databases: The European Commission database CosIng The cosmetic ingredients and suppliers database (Coptis)  Intended learning objectives According to the Academic Reference Standards (NARS), by the end of this course, students will be able to: Define cosmetic preparations, identify their types and understand their formulation, proper use and safety (knowledge and understanding). Integrate the knowledge gained in the course for the development of high quality and safe cosmetic products. For example, integrate knowledge of the principles of pharmaceutical formulation with knowledge of the structure and properties of different application sites of cosmetic preparations such as skin and hair (Intellectual skills) Compound cosmetic preparations, recommend cosmetic and medicated cosmetic products, provide pharmaceutical care and product-related information to consumers and patients (professional and practical skills) Enhance knowledge and skills by life-long learning and effective communication of information (general and transferable skills) Lecture Topics Lectures Date Topic 1 28/9 Introduction (Cosmetics vs OTC drugs vs Cosmeceuticals) 2 5/10 Introduction to skin basics 3 12/10 Antiperspirants and deodorants 4 19/10 Sun care products 5 29/10 Skin aging and exfoliatives 6 2/11 Anti acne 7 9/11 Anti acne 8 16/11 Midterm exam 9 23/11 Introduction to hair Basics 10 30/11 Shampoos and conditioners 11 7/12 Hair dyes 12 14/12 Hair loss and hair promotors 13 21/12 Hair chemical treatment and nanocosmetics Assessment Midterm 15 Practical 25 Oral 10 Final 50 Total 100 marks Practical Skin products: Cleansers Emollients Antiseptics (Hand sanitizer and Dettol) Sunscreen Skin lightening Anti acne lotion Foundation Lip balm/ lipstick Hair products: Shampoos  Marine-derived cosmetics materials Tutorials Liposomes in Cosmetics Role of surfactants in cosmetics Inorganic metal nanoparticles in cosmetics Nutricosmetic products Micro needling in skin care Regulation of cosmetics in Egypt Cosmetics products for patients Polymers in cosmetics Baby care products Oral health products Nail care products Enzymes in cosmetics Sulphate-free detergents for shampoos Waterless cosmetics Essential oils in cosmetics Personal Care Products Products intended to keep the skin and hair clean and fresh smelling. They include mainly: Skin care products Hair care products PCPs are classified as cosmetics or cosmetic products possessing medicinal or drug-like benefits (OTC drugs) or cosmeceuticals a) Cosmetics Articles intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering appearance without affecting the body's structure or functions Examples: skin creams, lotions, perfumes, lipsticks, fingernail polishes, eye and facial make-up, shampoos, permanent waves, hair colours, toothpastes, and deodorants. Such term does not include soap (alkali salt of fatty acid) to be used only for cleansing. b) What is meant by drugs? The FD&C Act defines drugs, in part, by their intended use, as "articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease" and "articles (other than food) intended to affect the structure or any function of the body of man or other animals" Examples of products that acts as both cosmetics and drugs Antidandruff shampoos A regular shampoo is a cosmetic because its intended use is to cleanse the hair. Antidandruff products are drugs since they correct an abnormal physical state of dandruff production, Consequently, an antidandruff shampoo is both a cosmetic and a drug. Examples of products that acts as both cosmetics and drugs Toothpastes that contain fluoride Toothpastes (dentifrice) with fluoride are drugs since fluoride prevents caries Toothpastes without fluoride are cosmetics since their main purpose is to freshen breath and whiten teeth. Examples of products that acts as both cosmetics and drugs Deodorants that are also antiperspirants Antiperspirants modify the organic function of sweat production and are therefore considered drugs. Deodorants only mask odours and are therefore cosmetics. b) Cosmetics that are also drugs (Cosmeceuticals) Cosmetics that are also intended to treat disease (anti-acne) or prevent disease (anti-caries fluoride toothpaste) or affect the structure or functions of the human body (antiperspirants, antidandruff shampoos, moisturizers or lipstick with SPF number) are considered also drugs and must comply with both of the drug and cosmetic provisions of the law. These are OTC drugs. FDA does not recognize the term “Cosmeceuticals”. Why?????  Increasingly though products which are considered cosmeceuticals actually do affect the structure or function of the skin and thus have drug-like effects but are marketed using appearance-based claims.  Example A drug may be marketed as a product that “reduces wrinkles by stimulating collagen production,” but A cosmetic which could potentially have essentially the same mechanism of action and clinical effects would be marketed as a product that “reduces the appearance of wrinkles.” Important Notes: When swallowing is secondary to the cosmetic purpose, but is an integral part of the product's use, the product is considered to be a food and not a cosmetic (e.g., a lozenge sits in the mouth to deodorize breath, but as it dissolves, the components are swallowed). When swallowing is incidental to the cosmetic's use, the product is a cosmetic (e.g., dentifrice ). How are the laws and regulations different for cosmetics and drugs? Cosmetics and drugs are different in the following areas: Approval Good manufacturing practice Registration Labeling Safety and efficacy FDA regulations of PCPs Cosmetics are regulated but not approved by the FDA Safety and Efficacy For drugs, it is required that safety and efficacy be established before sales and marketing could proceed. For cosmetics, safety and efficacy were not required to be demonstrated before sales and marketing of these products. Safety of cosmetics Safety is a major consideration for drugs. In contrast, a cosmetic is intended to improve the appearance of the skin. Here, efficacy is whether it provides “beauty,” and this may include acting as a camouflage for a disfiguration. In contrast, safety considerations need to carefully evaluated, recognizing that, in the past, systemic toxicity has resulted from cosmetic use. An example is hexachlorophene-containing cosmetic products, which were responsible for the death of 36 babies in France in 1972 Labelling of cosmetics Labeling means all labels and other written, printed or graphic matter on or accompanying a product. The label statements must appear on the inside and any outside container or wrapper. The label must : State the name of the product Identify by descriptive name or illustration the nature or use of the product, The net quantity of contents in terms of weight, measure, numerical count, or a combination of numerical count and weight or measure. Labelling of cosmetics (Cont.) The name and place (street address, city, state, and zip code) of business of the firm marketing the product If the distributor is not the manufacturer or packer, this must be stated on the label "Manufactured for......" or "Distributed by......" or similar, appropriate wording. Cosmetics bearing false or misleading label statements may be considered misbranded and may be subject to regulatory action. Declaration of ingredients According to the FDA: The ingredients of cosmetic products must be listed on the label in a descending order of predominance (concentration or amount) If the product is both a cosmetic and OTC drug product, the active ingredients must be listed on top of the ingredients list followed by inactive ingredients Ingredients with less than 1% concentration are listed in any order Cosmetic and skin care products expiration date ▪ In the United States; there are no regulations or guidelines from the FDA about the expiration date for skin-care or makeup products ▪ There are no regulations for expiration dates in the EU either, however, there is a system to give consumers an idea of how long the product should be kept after opening.  The Period After Opening (PAO) date. On products sold in Europe, a number followed by an M and an open jar symbol tells you when to throw a product away after opening. So 12M with an open jar symbol means you should throw the product out 12 months after you've opened it. In the EU this is commonly known as the Period After Opening (PAO) date.  Period After Opening (PAO) While the PAO dating system is useful to an extent, it ends up being empty legislation because ▪ PAO dates are generated without testing or regulated guidelines! ▪ The PAO date doesn't take into account how the consumer uses the product or how it is stored. When should I throw out a cosmetic product? It's ultimately up to consumers to make the call as to when a product has expired. If a product seems Unusually discolored, Runny or lumpy, Has separated, Has a strange odour, or Feels different on the skin, then it should absolutely be thrown away. Packaging that has expanded or has signs of deterioration is definitely a warning that something is wrong inside. As a rule: products that contain water as one of the first ingredients have the shortest shelf life after opening because….. Products made up of almost no water (such as powders) last the longest, because….. If your product is labeled "preservative-free" you should definitely take extra caution, because….. The shelf-life for eye-area cosmetics is more limited than for other products Label Claims Cosmetic labeling must be truthful and not misleading. Products intended for a therapeutic purpose, such as treating or preventing disease, are subject to regulation as drugs. Claims made for cosmetic products: "Alcohol Free" “Cosmeceutical” "Cruelty Free"/"Not Tested on Animals" "Hypoallergenic" "Organic” “Anti-ageing Organic cosmetics Organic cosmetics include only natural ingredients, derived from fruit, plants, seeds, oil, natural minerals, and so on. In order for cosmetics to truly be organic: ▪ All the cleaning and conditioning ingredients be made from organic materials ▪ The manufacturing process should be simple ▪ Non-agricultural water like floral water should not be counted to organic content.  It is not always easy to find 100% organic cosmetics. In many countries, including the U.S., so called “natural” cosmetics has 70-75% of organic ingredients, and 25-30% of synthetic chemical compounds, which are, however, potentially harmless to our skin or body. If a cosmetic is labeled “organic” is it still subject to the laws and regulations enforced by FDA? Yes. Cosmetic products labeled with organic claims must comply with the FDA regulations for labeling and safety requirements for cosmetics. Are cosmetics made with “organic” ingredients safer for consumers than those made with ingredients from other sources? No. An ingredient’s source does not determine its safety. For example, many plants, contain substances that may be toxic or allergenic. In general, cosmetic products should contain generally regarded as safe ingredients as defined by the U.S. Food Drug Administration (FDA) (i.e., not contain harmful substances). Some descriptive terms that are seen on some cosmetics Natural i.e. contains ingredients that are extracted directly from plants or animal products and are not produced synthetically. Tests have yet to prove that natural ingredients are good (or any better) for the skin.  Hypoallergenic Suggests that the product is less likely to cause allergic reactions; No scientific studies are required to back up this claim. Alcohol-free Generally means that a product does not contain ethyl alcohol, but It may contain fatty alcohols such as cetyl alcohol, stearyl alcohol or lanolin Noncomedogenic Contains no pore-clogging ingredients that may cause acne Manufacturers do not have to meet any criteria to make this claim  Soap Products Ordinary soap (alkali metal salts of fatty acids, true soap, e.g. sodium stearate or palmitate) with no added active ingredients does not require ingredient labeling. If a cosmetic claim is made on the label of a soap or cleanser such as moisturizing or deodorant, the product is a cosmetic product, and the label must list all ingredients. If a drug claim is made on a soap or cleanser such as antibacterial, antiperspirant or anti-acne, the product is a drug, and the label must list all active ingredients. When making a decision about buying a cosmetic product you should check out the list of the ingredients very carefully. Be especially careful when choosing perfumes since frequently perfume producers use various cancerous and toxic elements like mineral oils. Such chemical compounds can cause skin problems and affect the nervous system leading to depression, hyperactivity and excessive sensitivity. Important Note If you are trying out any product for the first time, then it is advisable to apply it on a small portion of your leg first to ensure that it suits you and you are not allergic to it.