FDA approves bemotrizinol — first new modern sunscreen filter in decades brings broader UV protection to U.S. shelves
The FDA approved bemotrizinol on June 9, 2026, adding the modern UV filter to the OTC sunscreen monograph since 1999, expanding broad‑spectrum UVA/UVB protection in U.S. sunscreens and marking the first new filter in decades.
- Regulatory milestone: The FDA issued a final administrative order on June 9, 2026, adding bemotrizinol to the OTC monograph as a permitted active.
- Product rollout: Bemotrizinol will be marketed initially as Parsol Shield by DSM Nutritional Products / DSM‑Firmenich, with an 18‑month sponsor exclusivity.
- Limits and use: The monograph allows up to 6% bemotrizinol in oils, lotions, creams, gels, sticks and certain spray forms and for ages 6 months and older.
- Policy implications: This is the first filter added via the OMOR pathway created by the CARES Act and may open the door for other modern filters.
What happened
On June 9, 2026, the FDA issued a final administrative order adding bemotrizinol to the OTC sunscreen monograph (M020). The agency’s action makes bemotrizinol a permitted sunscreen active ingredient in the United States. See the FDA news release for the agency announcement and context.
Product name, sponsor, limits and timing
Product name and sponsor: Bemotrizinol will be marketed initially as Parsol Shield by DSM Nutritional Products / DSM‑Firmenich. The trade summary and regulatory analyses describe the expected U.S. launch timing and exclusivity.
Limits and exclusivity: The monograph permits up to 6% bemotrizinol in finished sunscreen products. DSM holds an 18‑month marketing exclusivity as sponsor; after that window other manufacturers may include the filter if they meet monograph conditions.
Age and forms: The FDA considers bemotrizinol GRASE (generally recognized as safe and effective) for adults and children 6 months and older, and permits its use in oils, lotions, creams, gels, sticks and certain spray forms (see the product forms note).
How the FDA reached the decision
The agency used the new administrative pathway created by the CARES Act that lets companies file an OTC Monograph Order Request (OMOR) to add or change active ingredients. DSM submitted a Tier 1 OMOR in September 2024 requesting bemotrizinol at up to 6%.
The FDA proposed the change in December 2025, opened a public comment period that closed January 26, 2026, and finalized the order on June 9, 2026. For timeline and OMOR context, see the FDA news release and the FDA proposed order.
Agency framing: FDA officials positioned the move as part of broader OTC modernization. Commissioner Marty Makary, MD, MPH, said the agency had moved too slowly in the past and Americans deserved timely access to safe, effective and consumer‑friendly products. Acting director Karen Murry, MD, called bemotrizinol “a welcome addition” to existing sunscreen active ingredients.
Why bemotrizinol matters
About bemotrizinol (BEMT): Bemotrizinol is a modern, oil‑soluble UV filter with high photostability and strong broad‑spectrum UVA/UVB protection. That combination helps reduce sunburn risk and long‑term effects such as skin aging and some skin cancers. See the Dermatology review for literature and pharmacokinetic data.
Safety profile: FDA review found low skin absorption and low irritation in DSM’s data package. A pharmacokinetic study reported plasma levels rarely exceeded the FDA’s 0.5 ng/mL threshold used in prior safety assessments. Bemotrizinol pairs well with mineral filters like zinc oxide or titanium dioxide and is more photostable than several older U.S. filters.
Global context and comparisons
Bemotrizinol has been used for years in Europe, Australia and parts of Asia and Latin America. International maximum concentrations vary — up to 10% in the EU, MERCOSUR, Australia, Korea, China and ASEAN countries, and 6% in Canada. The U.S. limit was set at 6% based on the reviewed data. Historically, the U.S. list of actives had not added new modern filters since the 1999 monograph.
Regulatory and market impact
Bemotrizinol is the first sunscreen active added under the streamlined OMOR process. Legal and trade experts view the approval as a test of the CARES Act pathway that may open the door for other modern filters (for example, bisoctrizole or drometrizole trisiloxane) if sponsors submit OMORs that meet safety and labeling requirements. See analyses from HK Law and Diaz Trade Law.
Market rollout: DSM will sell Parsol Shield in the U.S., expected to reach the market from late 2026. During DSM’s 18‑month sponsor exclusivity other brands must wait to include bemotrizinol unless they negotiate licensing or supply agreements. After exclusivity, any OTC manufacturer may use bemotrizinol provided finished products meet monograph requirements such as SPF and broad‑spectrum testing and proper labeling.
Safety, research and next steps
Dermatology researchers note bemotrizinol cleared GRASE review and Maximal Usage Trial (MUsT) standards — rigorous tests for systemic exposure and safety under real‑world use — making it the first recent “Category 1” filter to meet these standards in FDA reviews. Experts expect the approval to encourage additional submissions for modern filters, though manufacturers must still meet strict testing and labeling rules.
Consumer guidance: The FDA reminds consumers that sunscreen is one layer of protection: use broad‑spectrum sunscreens with SPF 15 or higher, apply liberally, reapply after swimming or heavy sweating, and combine sunscreen with protective clothing, hats and shade. See the FDA consumer guidance.
What experts are saying
Dermatologists and policy analysts broadly called the decision a positive step that corrects a long regulatory delay which left U.S. consumers with fewer formulation options. Many predict bemotrizinol will enable lighter, less greasy sunscreens that are more cosmetically appealing and therefore more likely to be used daily.
“A welcome addition” — FDA acting director Karen Murry, MD, on bemotrizinol’s approval.
Implications for the Inland Empire
Economic impact: Local retailers, pharmacies and outdoor businesses in the Inland Empire could see Parsol Shield–containing products on shelves beginning in late 2026. Small businesses serving outdoor workers (landscaping, construction, agriculture) may stock cosmetically friendlier sunscreens for employee safety.
Public health: Residents of the Inland Empire face year‑round sun exposure. A more stable broad‑spectrum filter may reduce sunburn and long‑term skin damage among outdoor workers, park users and families, and the approval for children 6 months and older may reassure parents selecting sunscreens for infants and toddlers.
Policy and workplace guidance: Local public health agencies and county supervisors may update outreach and workplace safety guidance to highlight new sunscreen options. The FDA action also serves as an example of federal steps to modernize OTC regulation that local officials might cite when advocating workplace protections or public health funding.
Practical applications for residents
- Watch product labels for Parsol Shield or bemotrizinol (BEMT) when shopping for sunscreens.
- Continue to choose broad‑spectrum sunscreens with SPF 15 or higher and apply liberally and frequently.
- Employers should consider updating PPE and sunscreen supplies for outdoor staff once new formulations are commercially available.
- Local clinics and dermatologists can help guide choices for people with sensitive skin.
Sources and further reading
- FDA press announcement: “FDA expands sunscreen options for the first time in 20 years”
- FDA proposed order and background
- Diaz Trade Law summary: new sunscreen active ingredient
- HK Law analysis: FDA proposes first new sunscreen ingredient in decades
- Dermatology literature review and pharmacokinetics
- Consumer health coverage: New sunscreen formulas are on the way
