Bemotrizinol: The First New US Sunscreen Filter Proposed Since 1999
For 26 years the US filter list stood still while Europe and Asia raced ahead - this December 2025 proposal is the first real move to catch up.
On December 12, 2025, the FDA issued a proposed order to add bemotrizinol, a broad-spectrum UVA/UVB filter with very low skin absorption, to the OTC sunscreen monograph at concentrations up to 6%, deeming it GRASE for adults and children 6 months and older - the first new active since 1999.
The FDA states that it found bemotrizinol generally recognized as safe and effective at the proposed concentration for adults and children 6 months and older, while advocates at the Environmental Working Group welcomed it as a long-sought addition to the US filter list.
Questions we get a lot
What does GRASE mean for bemotrizinol?
GRASE stands for 'generally recognized as safe and effective,' the standard the FDA uses to clear OTC drug ingredients. In its December 2025 proposed order, the FDA found bemotrizinol GRASE at concentrations up to 6% for adults and children 6 months and older. A GRASE finding in a proposed order is a key milestone, though the order must still be finalized.
Why hasn't the US had a new sunscreen filter since 1999?
The US regulates sunscreens as over-the-counter drugs, a stricter and slower pathway than the cosmetic framework used in Europe and Asia, which left the active-ingredient list frozen since 1999. The Environmental Working Group has long described bemotrizinol as a sought-after filter held up by this process. The December 2025 proposal is the most concrete step yet toward adding one.
Is bemotrizinol safe for children?
In its proposed order, the FDA deemed bemotrizinol GRASE for adults and children 6 months and older at concentrations up to 6%, citing its broad-spectrum protection and very low skin absorption. As with all sunscreens, infants under 6 months should be protected primarily by shade and clothing. The proposal remains subject to a public comment period before any finalization.
r/SkincareAddiction: 'Why has the US not approved a new sunscreen filter since 1999, and does this bemotrizinol news finally change that?'