Cosmetic Labeling
FDA regulations list 13 categories of cosmetic products (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?
Categories of cosmetic products listed in 21 CFR 720.4(c):
- baby products
- bath preparations
- eye makeup preparations
- fragrance preparations
- hair preparations (non-coloring)
- hair coloring preparations
- makeup preparations (not eye)
- manicuring preparations
- oral hygiene products
- personal cleanliness products
- shaving preparations
- skin care preparations (creams, lotions, powder and sprays)
- suntan preparations (not sunscreens or sunblocks)
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.