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GRASE sunscreens
Hi all i do have a question about FDA registration of sunscreens. If i have a moisturizer with SPF, I use only zinc oxide at 21%, i am not using any colorants nor any prohibited substances that FDA list. If I am to sell this product in US , do i have to list and register it? It follows the OTC sunscreen monograph and is considered as GRASE, what does this mean? can i sell it as cosmetic or it has to be OTC? If OTC, do i have to list the drug and my establishment as well, do i still need an FDA premarket approval?
Can anyone help please
Thanks in advance -
2 Replies
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Yes, sunscreens are regulated as OTC drug products in the US. Your product must be registered with the FDA and must be manufactured in an FDA OTC-certified facility.
GRASE means Generally Regarded As Safe & Effective. If ZnO is the only sunscreen active ingredient in your formula, it should be GRASE and an OTC drug product. GRASE is a kind of nebulously defined term, but basically boils down to your product is safe for human use.
No, you cannot sell your product as a cosmetic since it contains an OTC Monograph active ingredient … at 21% ZnO, you are near the maximum allowed concentration of 25% ZnO.
There is not FDA pre-market approval for OTC drug products. You do need to register the product, have it manufactured by an OTC-certified CM and follow the labeling requirements.Yes, you do need to list: Active Ingredient: ZnO 21%
Inactive Ingredients: …
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Great Thanks @MarkBroussard. That clarifies it all.
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