-
What are the resources you would need to begin getting US FDA approval for sunscreen?
What type of professional advice is necessary to begin getting FDA approval for sunscreen and a proper SPF rating?
-
2 Replies
-
FDA does not “approve” specific sunscreens. They are made in compliance to the relevant monograph, drug GMPs, etc.
https://www.accessdata.fda.gov/drugsatfda_docs/omuf/OTCMonograph_M020-SunscreenDrugProductsforOTCHumanUse09242021.pdf -
Also, see this. https://www.fda.gov/cosmetics/resources-industry-cosmetics/small-businesses-homemade-cosmetics-fact-sheet
And this is important too. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/labeling-and-effectiveness-testing-sunscreen-drug-products-over-counter-human-use-small-entity