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


  • MarkBroussardMarkBroussard Member, Professional Chemist

    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: ... 

    Chemist/Microbiologist formulating in the Organic & Naturals arena under ECOCert/Natural Products Assn/Whole Foods/National Organic Program guidelines focused skincare & haircare products. 

    See website for details
  • ShamsShams Member
    Great Thanks @MarkBroussard. That clarifies it all. 
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