A 25-Year Wait: Inside the FDA's December 2025 Bemotrizinol Proposal
Why has the US lagged Korea, Japan and the EU on sunscreen ingredients - and how a single 2025 FDA proposal could finally close the gap on your shelf?
On December 12, 2025 the FDA published a proposed order to add bemotrizinol to OTC sunscreen monograph M020 as GRASE at up to 6%, citing broad-spectrum UVA/UVB protection and low skin absorption. EWG called it 'the most significant development in American sunscreen regulation in 25 years.'
The Environmental Working Group characterized the move as the most significant development in American sunscreen regulation in 25 years, while legal analysts framed it as the first new US filter in decades.
Questions we get a lot
Why has the US approved so few sunscreen filters?
The US regulatory pathway for new sunscreen actives historically moved very slowly, leaving the country reliant on older filters while Korea, Japan and the EU adopted newer ones. The December 12, 2025 bemotrizinol proposal is widely described as the first proposed new US UV filter in decades. Advocates have long pushed for more options.
How significant is the bemotrizinol proposal?
The Environmental Working Group called it the most significant development in American sunscreen regulation in 25 years. Legal analysts similarly described it as the first new US filter in decades. The proposal would allow bemotrizinol at up to 6% in over-the-counter sunscreens.
What is monograph M020?
OTC Monograph M020 is the FDA framework that governs over-the-counter sunscreen drug products in the US, including which active ingredients are recognized as safe and effective. The December 12, 2025 proposed order would amend M020 to add bemotrizinol at up to 6%. Amending the monograph is how new filters formally enter the US market.
r/SkincareAddiction: 'People keep saying American sunscreen is decades behind - is this bemotrizinol thing actually a big deal or just hype?'