FDA Approves New Sunscreen Chemical Bemotrizinol
Published Date: 6/10/2026
Notice
Summary
The FDA just gave a thumbs-up to adding bemotrizinol as a new active ingredient in sunscreens, letting it be used up to 6% concentration. This means sunscreen makers can now include this ingredient, which is safe and effective, in their products. The change is official as of June 10, 2026, and could lead to better sun protection options without extra costs for consumers.
Analyzed Economic Effects
3 provisions identified: 3 benefits, 0 costs, 0 mixed.
Manufacturers May Market Bemotrizinol Products Without New NDA
Under the final order (OTC000039) issued June 10, 2026, sunscreen products containing bemotrizinol that conform to the amended OTC Monograph M020 conditions (including concentration limits, permitted combinations, and permitted dosage forms) may be legally marketed without an approved application under section 505 of the FD&C Act. This enables sunscreen makers to offer bemotrizinol formulations under the OTC monograph pathway if they follow the specified conditions.
Bemotrizinol Added to OTC Sunscreens
The FDA amended OTC Monograph M020 on June 10, 2026 to add bemotrizinol as a recognized sunscreen active ingredient. You can now expect sunscreens to include bemotrizinol at concentrations up to 6 percent if the product meets the monograph conditions.
Spray Sunscreen Propellant Safety Requirement
The final order permits spray sunscreen dosage forms containing bemotrizinol only if they are manufactured and packaged with no propellant, or in a spray system where all propellant is isolated from the drug product and does not contact the formulation. This requirement is part of the amended OTC Monograph M020 effective June 10, 2026.
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