New Bemotrizinol Sunscreen Boost: FDA Calls for Comments
Published Date: 12/12/2025
Notice
Summary
The FDA is proposing a change to sunscreen rules to allow a new ingredient called bemotrizinol at up to 6% in over-the-counter sunscreens. This means sunscreen makers can use this ingredient once the rule is final, helping improve sun protection options. People and companies should send their thoughts by January 26, 2026, so the FDA can decide soon.
Analyzed Economic Effects
3 provisions identified: 3 benefits, 0 costs, 0 mixed.
GRASE Status for Bemotrizinol Products
If finalized, the proposed order would find that sunscreen drug products containing bemotrizinol are generally recognized as safe and effective (GRASE) when they meet the conditions set out in OTC Monograph M020. That determination would allow manufacturers to market bemotrizinol-containing OTC sunscreens under the monograph framework.
Bemotrizinol Allowed up to 6%
The FDA proposes adding bemotrizinol as an over-the-counter sunscreen active ingredient at concentrations up to 6 percent in OTC Monograph M020 if the proposed order (OTC000039) is finalized. This change would allow sunscreen products with bemotrizinol to be marketed under the OTC monograph conditions described in M020.
Permitted Dosage Forms and Spray Limits
The proposed order would permit bemotrizinol in specified dosage forms: oil, lotion, cream, gel, butter, paste, ointment, stick, and spray. Spray forms are allowed only if manufactured and packaged with no propellant or if any propellant is isolated from the drug formulation so there is no contact between propellant and the product formulation.
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