Cosmetic Labeling
The Modernization of Cosmetic Regulations Act (MoCRA) was passed at the end of December 2002. As a result, cosmetic companies must now have safety data for their products, cosmetic manufacturing facilities must be registered with FDA, and cosmetic products must be listed with FDA. The law also increased the number of cosmetic categories from 13 to 17; many of which have subcategories. (see below).
Cosmetics are defined as “(1) articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and (2) articles intended for use as a component of any such articles; except that such term shall not include soap.” Each category of products has unique requirements for proper cosmetic labeling.
In addition to basic consumer product labeling requirements, cosmetics are required to carry a statement informing consumers if safety testing has not been carried out on the product. While cosmetic labels are simple compared to other FDA-regulated products, there are nuances to these and all product label regulations. How much safety data is required to avoid including the FDA safety statement on your label? What claims are allowed on cosmetic products? What ingredients are permitted?
Cosmetic Product Categories and Codes
(01) Baby products.
(a) Baby shampoos.
(b) Lotions, oils, powders, and creams.
(c) Baby wipes.
(d) Other baby products.
1. Leave-on.
2. Rinse-off.
(02) Bath preparations.
(a) Bath oils, tablets, and salts.
(b) Bubble baths.
(c) Bath capsules.
(d) Other bath preparations.
(03) Eye makeup preparations (other than children’s eye makeup preparations).
(a) Eyebrow pencils.
(b) Eyeliners.
(c) Eye shadows.
(d) Eye lotions.
(e) Eye makeup removers.
(f) False eyelashes.
(g) Mascaras.
(h) Eyelash and eyebrow adhesives, glues, and sealants.
(i) Eyelash and eyebrow preparations (primers, conditioners, serums, fortifiers).
(j) Eyelash cleansers.
(k) Other eye makeup preparations.
(04) Children’s eye makeup preparations.
(a) Children’s eyeshadows.
(b) Other children’s eye makeup.
(05) Fragrance preparations.
(a) Colognes and toilet waters.
(b) Perfumes.
(c) Powders (dusting and talcum) (excluding aftershave talc).
(d) Other fragrance preparations.
(06) Hair preparations (non-coloring).
(a) Hair conditioners.
1. Leave-on.
2. Rinse-off.
(b) Hair sprays (aerosol fixatives).
(c) Hair straighteners.
(d) Permanent waves.
(e) Rinses (non-coloring).
(f) Shampoos (non-coloring).
1. Leave-on.
2. Rinse-off.
(g) Tonics, dressings, and other hair grooming aids.
(h) Wave sets.
(i) Other hair preparations.
1. Leave-on.
2. Rinse-off.
(07) Hair coloring preparations.
(a) Hair dyes and colors (all types requiring caution statement and patch test).
(b) Hair tints.
(c) Hair rinses (coloring).
1. Leave-on.
2. Rinse-off.
(d) Hair shampoos (coloring).
1. Leave-on.
2. Rinse-off.
(e) Hair color sprays (aerosol).
(f) Hair lighteners with color.
(g) Hair bleaches.
(h) Eyelash and eyebrow dyes.
(i) Other hair coloring preparations.
1. Leave-on.
2. Rinse-off.
(08) Makeup preparations (not eye)(other than makeup preparations for children).
(a) Blushers and rouges (all types).
(b) Face powders.
(c) Foundations.
1. Traditional applications.
2. Airbrush applications.
(d) Leg and body paints.
1. Traditional applications.
2. Airbrush applications.
(e) Lipsticks and lip glosses.
(f) Makeup bases.
1. Traditional applications.
2. Airbrush applications.
(g) Makeup fixatives.
(h) Other makeup preparations.
1. Traditional applications.
2. Airbrush applications.
(09) Makeup preparations for children (not eye).
(a) Children’s blushers and rouges (all types).
(b) Children’s face paints.
(c) Children’s face powders.
(d) Children’s foundations.
(e) Children’s lipsticks and lip glosses.
(f) Children’s color hairsprays.
(g) Other children’s makeup.
(10) Manicuring preparations.
(a) Basecoats and undercoats.
(b) Cuticle softeners.
(c) Nail creams and lotions.
(d) Nail extenders.
(e) Nail polishes and enamels.
(f) Nail polish and enamel removers.
(g) Other manicuring preparations.
(11) Oral products.
(a) Dentifrices (aerosols, liquids, pastes, and powders).
(b) Mouthwashes and breath fresheners (liquids and sprays).
(c) Other oral products.
(12) Personal cleanliness.
(a) Bath soaps and body washes.
(b) Deodorants (underarm).
1. Sticks, roll-ons, gels, creams, and wipes.
2. Sprays.
(c) Douches.
(d) Feminine deodorants.
1. Leave-on.
2. Rinse-off.
(e) Disposable wipes.
(f) Other personal cleanliness products.
1. Leave-on.
2. Rinse-off.
(13) Shaving preparations.
(a) Aftershave lotions.
(b) Beard softeners.
(c) Men’s talcum.
(d) Pre-shave lotions (all types).
(e) Shaving creams (aerosol, brushless, and lather).
(f) Shaving soaps (cakes, sticks, etc.).
(g) Other shaving preparation products.
(14) Skin care preparations, (creams, lotions, powder, and sprays).
(a) Cleansing (cold creams, cleansing lotions, liquids, and pads).
(b) Depilatories.
(c) Face and neck (excluding shaving preparations).
1. Leave-on.
2. Rinse-off.
(d) Body and hand (excluding shaving preparations).
1. Leave-on.
2. Rinse-off.
(e) Foot powders and sprays.
(f) Moisturizing.
(g) Night.
(h) Paste masks (mud packs).
(i) Skin fresheners.
(j) Other skin care preparations.
1. Leave-on.
2. Rinse-off.
(15) Suntan preparations.
(a) Suntan gels, creams, and liquids.
(b) Indoor tanning preparations.
1. Traditional applications (creams, lotions, etc.).
2. Airbrush applications.
3. Spray applications.
4. Professional airbrush tanning applications.
5. Professional spray tanning applications.
(c) Other suntan preparations.
(16) Tattoo preparations.
(a) Permanent tattoo inks.
(b) Temporary tattoo inks.
(c) Other tattoo preparations.
(17) Other preparations (i.e., those preparations that do not fit another category).
View Cosmetics resources.
Over the Counter Drugs & Homeopathics
Over the counter drugs must either comply with published FDA monographs or be approved through the same process as prescription drugs. Homeopathic products are a special class of drugs that most follow the monographs of the Homeopathic Pharmacoepia of the United States. The labels for homeopathics and other over the counter drug products (OTCs) must strictly adhere to FDA labeling regulations. OTCs must have Drug Facts Boxes with information necessary to ensure the safe use of the product by the consumer. Each class of OTC drugs has a unique set of requirements for the indication, uses, warning and other sections of the drug facts box. The ingredients in foods, dietary supplements and cosmetics must be listing in descending order of prominence. However, on OTC drug products both active and inactive ingredients are listed in alphabetical order.
Over the counter drugs must either comply with published FDA monographs or be approved through the same process as prescription drugs. The labels for over the counter drug products (OTCs) must strictly adhere to FDA labeling regulations. OTCs must have Drug Facts Boxes with information necessary to ensure the safe use of the product by the consumer. Each class of OTC drugs has a unique set of requirements for the indication, uses, warning and other sections of the drug facts box. The ingredients in foods, dietary supplements and cosmetics must be listing in descending order of prominence. However, on OTC drug products both active and inactive ingredients are listed in alphabetical order.