Cosmetic Ingredients

 How are cosmetic ingredients regulated by FDA? 

Cosmetic ingredients may not be listed on the prohibited list of ingredients. In addition, cosmetic ingredients may not be harmful when consumers use the product according to the labeled instructions or customary or expected way. There is one exception for coal-tar hair dye. FDA can not take action against a cosmetic company with coal-tar hair dye so long as the appropriate warning appears on the labeling "Caution - This product contains ingredients which may cause skin irritation on certain individuals and a preliminary test according to accompanying directions should first be made. This product must not be used for dyeing the eyelashes or eyebrows; to do may cause blindness." 

What cosmetic ingredients are prohibited or restricted? 

The following cosmetic ingredients have specific regulations either restricting its use or prohibiting its use:

  1. Bithionol
  2. Chlorofluorocarbon propellants
  3. Chloroform
  4. Halogenated salicylanilides
  5. Hexachlorophene
  6. Mercury compounds
  7. Methylene chloride
  8. Prohibited cattle materials due to "Mad Cow Disease" 
  9. Sunscreens in cosmetics. This results in the cosmetic being classified a drug. Its not that sunscreen can not be added to a cosmetic product, but the use is restricted and there are specific drug regulations that the cosmetic must now comply with. For additional information visit our page on FDA Drug Regulations for OTC
  10. Vinyl chloride
  11. Zirconium-containing complexes. 

How are color additives regulated by FDA? 

Specific color additive are permitted in cosmetic ingredients. In addition, each color additive is limited to what part of the body and/or face it can be used. Furthermore, color additives in any product are regulated by FDA and require that some color additive batches be tested and certified by FDA prior to being used in a product being distributed in the US. For additional information visit our page on color additives. 

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