FDA Proposes Bemotrizinol: The First New US Sunscreen Filter Since the '90s
A next-gen filter the rest of the world already uses just took its biggest step toward US shelves - and it reshapes the reef-safe debate too.
On December 12, 2025, the FDA issued a proposed administrative order to add bemotrizinol (up to 6%) to the OTC sunscreen monograph - the first new active ingredient proposed for the US monograph since the late 1990s - following DSM's September 23, 2024 order request.
Industry and regulatory observers note that the FDA's proposed order is significant precisely because it would be the first new sunscreen active proposed for the US monograph in roughly a quarter century, signaling movement on long-stalled filter modernization.
Questions we get a lot
What exactly did the FDA propose for bemotrizinol?
On December 12, 2025, the FDA issued a proposed administrative order to add bemotrizinol to the OTC sunscreen monograph at concentrations up to 6%. It would be the first new active ingredient proposed for the US monograph since the late 1990s. The action followed a formal order request from DSM submitted on September 23, 2024.
Why is this filter a big deal for US sunscreens?
Bemotrizinol would be the first new sunscreen active proposed for the US monograph in roughly 25 years, ending a long stretch without new filters. Coverage from Cosmetics & Toiletries frames it as part of a broader push to modernize OTC and sunscreen standards. It could expand the limited US filter palette.
Is bemotrizinol the same as oxybenzone?
No. Bemotrizinol is a distinct broad-spectrum UV filter and is not oxybenzone or octinoxate, the chemicals at the center of many reef-safe debates. That distinction is part of why its proposal is relevant to the reef-safe conversation. As a proposed order, it is a step in the regulatory process rather than a finished approval.
r/SkincareAddiction: 'Wait, the FDA is finally proposing a new sunscreen filter? When could bemotrizinol actually show up in US products?'