This is a major development, the likes of which haven’t been seen since the late 1990s: the U.S. FDA has just issued a Final Order to add a UV filter to Monograph M020 on sunscreen products.
The Final Administrative Order (OTC000039) was published on June 10, 2026.
It amends Monograph M020 on OTC sunscreen products to add bemotrizinol (CAS No. 187393-00-6, EC No. -, INCI: bis-Ethylhexyloxyphenol Methoxyphenyl Triazine) and authorizes its use as a sunscreen active ingredient.
The FDA states that it considers the substance to be GRASE (generally recognized as safe and effective) for use in sunscreen products for adults and children six months of age and older.
Products containing bemotrizinol may now be marketed in the United States without prior authorization.
FDA comment: “Bemotrizinol is the first new active ingredient added to an OTC monograph under the streamlined process established by the CARES Act. Today’s action aligns with the Make America Healthy Again (MAHA) Strategy Report priority, ‘FDA will promote innovation in the sunscreen market, and improve regulatory processes for over-the-counter sunscreen, which has fallen behind other countries.’”
Terms of Use
To be used, Bemotrizinol must meet certain conditions.
• It must be present in the product at a maximum concentration of 6%, and the product’s sun protection factor must not be less than SPF 2.
• A single product may combine Bemotrizinol with any filter or ingredient listed in the …
