FDA approves bemotrizinol sunscreen — first new broad-spectrum UV filter in more than 25 years
The U.S. Food and Drug Administration has approved bemotrizinol, a new broad-spectrum organic UV filter for over-the-counter sunscreens, marking the first new sunscreen active ingredient added in more than 25 years and expanding protection options.
- Regulatory milestone: The FDA issued a final order adding bemotrizinol to the OTC sunscreen monograph (Monograph M020) — the first new active since the late 1990s; see the FDA statement.
- Safety & use: Bemotrizinol is classified GRASE for adults and children aged 6 months and older and is allowed at concentrations up to 6% in U.S. sunscreens (see the peer review).
- Market rollout: DSM will sell bemotrizinol as Parsol Shield with an estimated ~18‑month exclusivity window before other makers can incorporate it.
What the FDA did and why it matters
The FDA used the modernized OTC Monograph Order Request (OMOR) pathway — established under the CARES Act — to add bemotrizinol to the sunscreen monograph (M020). This was the first sunscreen active to complete the Tier 1 OMOR path successfully. The agency proposed the change on Dec. 12, 2025, accepted public comments and issued a final administrative order. For the official announcement, see the FDA statement.
Why it matters: Commissioner Marty Makary, M.D., M.P.H., framed the approval as part of ongoing modernization: “We’re continuing to modernize the regulation of sunscreen and other over‑the‑counter drug products,” and said the agency aims to give Americans access to safer, more effective OTC options.
Sponsor, brand and exclusivity
DSM Nutritional Products LLC (now part of DSM‑Firmenich) submitted the OMOR in September 2024 requesting bemotrizinol be allowed at up to 6% in OTC sunscreens. DSM will market the ingredient under the brand name Parsol Shield and expects U.S. product launches in 2026. Industry reporting indicates an expected exclusivity window of roughly 18 months, after which other manufacturers can formulate with bemotrizinol (see industry commentary).
Scientific profile: what bemotrizinol does
Bemotrizinol (BEMT) is an organic UV filter widely used in Europe and Asia. It offers broad‑spectrum UVA and UVB protection, is highly photostable (resists breakdown in sunlight), and complements other filters for durable protection. For deeper clinical and policy analysis, see the peer‑reviewed policy and clinical review.
Safety findings that mattered to regulators
Regulators reviewed clinical pharmacokinetic studies showing plasma levels of bemotrizinol rarely exceeded 0.5 ng/mL — the FDA threshold used to flag potential systemic safety concerns. Reported adverse effects were few and mostly mild. Based on available data, the FDA concluded bemotrizinol at concentrations up to 6% is GRASE for adults and children older than six months (see the peer review and the FDA statement).
“Plasma levels rarely exceeded 0.5 ng/mL, and reported side effects were few and mostly mild,” according to reviews cited by regulators.
How U.S. rules compare to other countries
Bemotrizinol has been permitted in the European Union, MERCOSUR, Australia, Korea, China and ASEAN markets for years — often at concentrations up to 10% in some jurisdictions. Canada already permits bemotrizinol up to 6%, matching the new U.S. limit. The U.S. lagged because adding new actives previously required lengthy rulemaking; experts note bemotrizinol’s approval may open the door for other modern filters (see the peer review).
What consumers should know now
- Labeling: Look for bemotrizinol or brand names such as Parsol Shield in the active ingredient list; U.S. products will state concentration (up to 6%) as required.
- Use: The FDA continues to recommend broad‑spectrum sunscreens with SPF 15+, reapplying every two hours, and combining sunscreen with hats, clothing and shade (see the FDA sunscreen Q&A).
- Competition: After an ~18‑month exclusivity period, more brands will likely offer bemotrizinol formulations, increasing choices and potentially lowering prices.
Regulatory context and the larger change
The OTC sunscreen monograph hadn’t added a new active since the late 1990s. In 2021 the FDA reviewed several filters and found some — such as zinc oxide and titanium dioxide — clearly GRASE, while others lacked sufficient long‑term systemic data. The CARES Act and the OMOR pathway were created to accelerate updates to OTC monographs. Bemotrizinol is the first clear test case that the OMOR process can work (see the FDA background materials and analysis).
Implications for Paso Robles, California
Paso Robles is a tourism and wine country community where outdoor workers and visitors depend on reliable sun protection. The arrival of bemotrizinol-based sunscreens — initially as Parsol Shield — could broaden product selection in local pharmacies, specialty retailers and online beginning in 2026, with more options appearing after the exclusivity period ends.
Economic and retail impact
Local drugstores, gift shops and outdoor outfitters may expand sunscreen offerings. Early sales will likely be in specialty and pharmacy channels; greater brand competition later may lower prices and increase availability.
Health and outdoor workers
Vineyard and ranch workers, grounds crews and other outdoor employees may benefit from bemotrizinol’s photostability and low reported irritation. Employers and safety managers should monitor formulations for practical features (non‑greasy textures, sticks, sweat‑resistant lotions) that match field needs.
Family and community use
Families gain another pediatric‑safe option: the FDA’s GRASE determination includes children 6 months and older. Pediatricians, clinics and school programs can update guidance and procurement when products arrive.
Tourism and recreation
Event planners, wineries and parks can recommend or stock newer sunscreens. Public messaging that pairs sunscreen use with hats, shade and scheduling can protect visitors and support local businesses.
Local supply chains and small manufacturers
After exclusivity ends, local skincare makers and small brands could reformulate using bemotrizinol, creating opportunities for regionally tailored products for Paso Robles retailers and tourist markets.
Reporting and verification
This article draws on the FDA’s official announcement and peer‑reviewed analyses. Key sources include the FDA press announcement, a peer‑reviewed policy and clinical review, legal and industry commentary at AFSLaw, and background materials at FDA background materials. For an industry discussion on timing and exclusivity see the industry discussion on market timing and exclusivity.
Sources: FDA statement; peer review; industry commentary; FDA background materials; industry discussion (YouTube).
