The FDA has strict laws regarding both the ingredients and labeling of cosmetic products. Some cosmetics are even classified as drugs, making the requirements even stricter and more difficult to comply with. Cosmeregcan assist you in FDA cosmetic labeling and ingredient compliance by cross-referencing your labeling against the Code of Federal Regulations, the Federal Register, the VCRP Cosmetic Ingredient Dictionary, the FDA Labeling Manual, and more. Since the State of California has even stricter rules governing cosmetics, we provide special services for those wishing to sell products in California.
What are the requirements of Cosmetic Labeling?
Labeling means all labels and other written, printed or graphic matter on or accompanying a product. The label statements must appear on the inside as well as any outside container or wrapper. But ingredient labeling and statement of the net quantity of contents on the principal display panel, only apply to the label of the outer container.
Cosmetic Labeling consists of two parts; Principal Display Panel and Information Panel.
The requirements for the Principal Display Panel (PDP) are:
Name of Product
Identity Statement: An identity statement indicating the nature and use of the cosmetic product, by means of either the common or usual name, a descriptive name or illustration.
Net Quantity: An accurate statement of the net quantity of contents of the cosmetic in the package in terms of weight, measure, numerical count, or a combination of numerical count and weight or measure.
Warning: If the cosmetic product contains an ingredient for which adequate substantiation of safety has not been obtained, a warning must be placed on the PDP like “Warning - the safety of this product has not been determined”
The requirements for the Information Panel (IP) are:
Name and place of business: This may be the manufacturer, packer, or distributor
Language: All label or labeling statements required by law or regulation must be in English. If the label contains any foreign language representation, all statements required by regulation must also appear on the label in foreign language.
Distributor statement: If the name and address are not those of the manufacturer, the label must say "Manufactured for..." or "Distributed by..."
Cosmetic Warning and Caution Statements: Cosmetics which may be hazardous to consumers when misused must bear appropriate label warnings and adequate directions for safe use. Flammable cosmetics such as aerosols, feminine deodorant sprays, and children's bubble bath products are an example of products that require specific warnings
Ingredients declaration: The ingredient declaration must be conspicuous so that it is likely to be read and understood by at the time of purchase. You must use an appropriate information panel and make sure that the letters are not less than 1/6 inches in height and without obscuring design, vignettes, or crowding. If you do not have sufficient space for such declaration, the declaration may appear on a firmly affixed tag, tape, or card.
Ingredient name: You may use the International Nomenclature of Cosmetic Ingredients (INCI) name. or in absence, you should use the name given by the United States Pharmacopeia, National Formulary, Food Chemical Codex, USAN, and the USP dictionary of drugs names
Ingredient listing: The ingredients must be listed in descending order of predominance. Exceptions are active drug ingredients, ingredients with less than 1% concentration, and color additives. Fragrance and flavor compounds may be declared in descending order of predominance as "fragrance" and "flavor."
Material facts: You should reveal material facts (e.g.: directions for safe use if a cosmetic product has the potential to be misused), or your product will be considered as misbranded or adulterated.
Want to verify that your labeling meets current U.S. FDA requirements?
Have a shipment detained due to labeling violations and need immediate assistance?
Have not yet designed your product labeling and would like assistance?
Cosmereg helps cosmetic companies modify their cosmetic labeling and ingredient compliance by cross-referencing your labeling to comply with FDA regulations.
