Sunscreens are regarded as drugs (OTC drugs) by the FDA which has several implications:
  • FDA Registration: Sunscreen manufacturers must register with the FDA, work under GMP guidelines, and update their list of products twice annually. cGMP guidelines must include recall procedures and adverse reaction reporting procedures.
  • Labeling rules: All sunscreen ingredients must be listed separately in the ingredient list under "active ingredients" together with the concentration used in the product.
  • Validation of claims: Claims made on the label suggesting that the product offers sun protection (UVA and/or UVB) must be substantiated with clinical and/or in-vitro testing in a certified laboratory. Further testing to prove the safety of the product, usually a repeated insult patch test (RIPT) (done on humans), needs also to be done. You can read more about this in our resource section.
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