With the exception of color additives and a few prohibited ingredients, a cosmetic manufacturer may use almost any raw material as a cosmetic ingredient and market the product without an approval from FDA. The Federal Food, Drug, and Cosmetic Act requires that color additives used in cosmetics must be tested for safety and be listed by the FDA for their intended uses.

The use of the following ingredients is either restricted or prohibited in cosmetics: bithionol, mercury compounds, vinyl chloride, halogenated salicyanilides, zirconium complexes in aerosol cosmetics, chloroform, methylene chloride, chlorofluorocarbon propellants, hexachlorophene, and methyl methacrylate monomer in cosmetic nail products.

In addition, although not required by law or regulation, cosmetic and fragrance manufacturers have voluntarily agreed to eliminate or to limit maximum use levels of certain ingredients that have been found to cause skin discoloration, redness and irritation, or other allergic reactions.


U. S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
Office of Cosmetics Fact Sheet
February 23, 1995

FDA Prohibited Ingredients List

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