The US Catches Up: FDA Proposes Bemotrizinol (Docket OTC000039)
If you've ever envied the lightweight, high-UVA sunscreens sold abroad, this is the moment the US started catching up.
On December 11-12, 2025, the FDA issued a proposed administrative order (docket OTC000039) to amend OTC Monograph M020 to add bemotrizinol at concentrations up to 6% as a GRASE sunscreen active ingredient for adults and children 6 months and older - the first new US sunscreen filter proposed in over 25 years.
The FDA states that it is expanding sunscreen options for the first time in 20 years through this proposed order, a framing echoed by legal analysts at Holland & Knight who call bemotrizinol the first new sunscreen ingredient the agency has advanced in decades.
Questions we get a lot
What is docket OTC000039 and Monograph M020?
Docket OTC000039 is the FDA proceeding under which the agency issued its December 2025 proposed order, and Monograph M020 is the OTC sunscreen monograph the order would amend to add bemotrizinol. The proposal sets bemotrizinol at concentrations up to 6% as a GRASE active. These identifiers let the public track and comment on the action.
Who is bemotrizinol proposed to be safe for?
The FDA's proposed order recognizes bemotrizinol as GRASE for adults and children 6 months and older at concentrations up to 6%. Infants under 6 months should still be protected mainly by shade and clothing rather than sunscreen. The proposal would make bemotrizinol the first new US sunscreen filter in over 25 years.
Does this proposal mean bemotrizinol is approved now?
Not yet. The December 11-12, 2025 action is a proposed administrative order, a key step that still requires public comment and finalization before products can rely on bemotrizinol in the US. Holland & Knight describes it as the first new sunscreen ingredient the FDA has proposed in decades. Until finalized, US formulas cannot yet use it.
r/SkincareAddiction: 'Is bemotrizinol going to be in my next sunscreen, or is this just paperwork that takes years to mean anything?'