Cosmetic products sold in the USA must comply with the labelling requirements of the Federal Food Drug and Cosmetic Act (FD&C Act), the Fair Packaging and Labeling Act (FP&L Act), and the regulations set out by the FDA under these two laws.
The FD&C Act strictly prohibits the sale of adulterated or misbranded cosmetics. A cosmetic product is considered misbranded if, among other things, it includes false or misleading labelling, including product claims, or does not include the name and address of the manufacturer, packer or distributor. Such products may be subject to regulatory action.
The US legislation has specific rules on where certain information has to appear on the label of the cosmetic product. In order to place the information where it should be, it is important to know the terms, such as the outer container and inner container. The outer container has principal display panel (PDP) and information panels (IP) whereas the inner container has a front panel and information panels. In order to comply with the labelling requirements, it is important to know which information has to be listed on certain panels. Additionally, for certain information, it is important to use the correct size of lettering and to place it on the specific location of the packaging as required by the regulation.
Labelling statements laid down in the FD&C Act have to appear on the outer and inner container. Requirements of the FP&L Act, such as the ingredient list and net quantity, can appear only on the outer container label.
The following information has to appear on the PDP:
- Product name
- Product identity (the nature or use of the product): It can be expressed using a common or usual name of cosmetics, a descriptive name, illustration, or in cases where the nature of cosmetic is obvious, a fanciful name.
- Net quantity of contents: using U.S. customary units (gal., fl. oz, oz., lb., etc.)
- 740.10 warning: If the safety of the product hasn’t been substantiated, the label has to include the following warning: “Warning – The safety of this product has not been determined”.
The following information has to appear on the IP:
- Ingredient list: Ingredients must be listed in a descending order by concentration. Ingredients with a concentration below 1% can be listed in any order after those with a concentration above 1%. Colour additives should be listed at the end and should be named as designated by the FDA (for example: D&C Green No. 5). Perfumes and flavours have to be listed as “fragrance” and “flavor”. An ingredient, accepted by the FDA as a trade secret, is not required to be listed on the ingredient list. Such ingredients may be listed under ‘’and other ingredients’’ at the end of the ingredient list. Incidental ingredients do not need to be included in the ingredient list.
- Directions for safe use (where relevant)
- Warning statements: If the use of products requires any warnings, they have to be listed on the label. Cosmetic aerosols, feminine deodorant sprays, foaming detergent bath products and sun tanning products have to include exact warning statements listed in the regulation.
- Name and place of business: The name and address of the manufacturer, packer or distributor.
- Country of origin (for imported products)
- Batch number (not a requirement but it is a common practice to include it)
- Expiry date (not a requirement but cosmetic firms are responsible for the safety of their products)
All required labelling information must be in English. The only exception are products distributed solely in a U.S. territory where a different language is predominant, such as Puerto Rico.
Additional state regulations
It is important to note that some states have additional state cosmetic regulations, such as Prop 65 in California. Prop 65 includes the list of chemicals which are known to cause cancer, birth defects or other reproductive harm. If products sold in California contain any of those ingredients, they need to include a “clear and reasonable” warning on the labels.