GRASE sunscreens

Shams

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

MarkBroussard

@Shams

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: ... 

Shams

Great Thanks @MarkBroussard. That clarifies it all.