FDA make up regulations

FDA regulations for makeup products depend on the intended use of the product. If the makeup product is intended to alter the physical appearance of part of the body temporarily, then it will be regulated as a cosmetic product. However, if the product is intended to cure diseases or medical conditions, it will be classified as a drug. For example, sunscreen makeup products and SPF lip balm are considered drugs. Some face washes that claim to cure acne are also considered drug products.



If your makeup product does not claim to cure or treat a medical condition, it will be regulated as a cosmetic product. FDA approval is not required for such cosmetic products. However, if your product is intended to treat or cure any medical condition, you must comply with OTC drug requirements.


Makeup products marketed with drug claims are considered misbranded, and the FDA may take enforcement action against such products.

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