FDA adds bemotrizinol to sunscreen rules, expanding U.S. UV filter options
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FDA regulates sunscreens as OTC drug products and, in June 2026, added bemotrizinol as a permitted active ingredient. The change expands the available options for safe and effective sun protection products. Proper sunscreen use remains relevant to reducing sunburn, skin cancer, and early skin aging risk.
FDA’s June 2026 final order adds bemotrizinol to OTC Monograph M020 at up to 6%, expanding U.S. sunscreen actives under the CARES Act administrative-order process. For formulators and BD teams, the decision resets the available UV-filter set while keeping GRASE marketing tied to monograph conditions.
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Key Takeaways
- Final order OTC000039 adds bemotrizinol (≤6%) to OTC Monograph M020; products meeting amended conditions may be GRASE without a separate NDA.
- FDA announced the order’s availability on June 10, 2026 (91 FR 35220); DSM Nutritional Products LLC submitted the Tier 1 OMOR on September 23, 2024.
- Allowed dosage forms include oil, lotion, cream, gel, butter, paste, ointment, stick, and non-propellant-contact sprays.
- Broader consumer sunscreen guidance still sits on FDA’s OTC sunscreen education pages alongside monograph conditions.
What did the FDA bemotrizinol sunscreen order change?
Per the Federal Register notice (91 FR 35220, June 10, 2026), FDA issued final administrative order OTC000039 amending OTC Monograph M020 to add bemotrizinol at concentrations up to 6% as a sunscreen active ingredient. A product containing bemotrizinol is generally recognized as safe and effective (GRASE) if it meets the amended monograph conditions.
FDA issued the order under section 505G(b)(1) of the FD&C Act. The full order text is posted through the OTC Monographs@FDA portal.
How did the OMOR process unfold?
On September 23, 2024, DSM Nutritional Products LLC submitted a Tier 1 OTC monograph order request (OMOR) asking FDA to find bemotrizinol GRASE under M020 conditions. A proposed-order notice of availability ran on December 12, 2025 (90 FR 57765). FDA considered timely comments and, according to the June 2026 notice, did not make changes to the final order based on those comments.
That path is the CARES Act administrative-order route for OTC monograph amendments, distinct from a product-specific NDA approval for a single branded sunscreen.
Which formulations and combinations are in scope?
The Federal Register summary states that, among other requirements, bemotrizinol sunscreens must meet conditions on concentration, permitted combinations with other sunscreen or skin-protectant actives, and dosage form. Permitted forms listed are oil, lotion, cream, gel, butter, paste, ointment, stick, and spray—provided spray products have no propellant or isolate propellant so there is no propellant–formulation contact.
- Concentration ceiling: up to 6% bemotrizinol.
- Marketing without a section 505 approved application still requires full monograph conformity.
- Formulators should read OTC000039 itself for combination restrictions beyond the FR summary.
How does this sit beside FDA consumer sunscreen guidance?
FDA’s consumer page “Sunscreen: How to Help Protect Your Skin from the Sun” still frames sunscreens as OTC drug products and explains SPF, broad-spectrum, and use practices. The bemotrizinol order expands which actives can be lawfully formulated under M020; it does not replace labeling, SPF testing, or other monograph requirements that apply to finished products.
What remains open after OTC000039
The FR notice announces availability of the final order; commercial exclusivity terms, if any, are not restated in the short Federal Register summary used here and should be verified in OTC000039 / related exclusivity determinations. Broader pending sunscreen monograph updates that apply to all M020 products remain a separate watch item for manufacturers.
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Frequently Asked Questions
What did FDA change for bemotrizinol sunscreen products?
Final administrative order OTC000039 amends OTC Monograph M020 to add bemotrizinol at concentrations up to 6% as a sunscreen active ingredient that can be GRASE if monograph conditions are met.
When was the bemotrizinol final order announced?
FDA announced availability of final order OTC000039 in the Federal Register on June 10, 2026 (91 FR 35220), following a proposed-order notice on December 12, 2025.
Which dosage forms are allowed for bemotrizinol sunscreens?
Permitted forms include oil, lotion, cream, gel, butter, paste, ointment, stick, and spray when the spray has no propellant-formulation contact; powders and propellant-contact aerosols are not permitted under the order text summarized in the Federal Register notice.
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