FDA proposes bemotrizinol for U.S. sunscreens — a modern broad‑spectrum UV filter long used overseas
The FDA has proposed adding bemotrizinol, a modern, photostable broad‑spectrum UVA/UVB filter long used overseas, to the OTC sunscreen monograph — potentially available in U.S. sunscreens by early 2026, offering expanded protection for consumers.
Key takeaways
- Proposed addition: The agency issued a proposed administrative order to add bemotrizinol to Monograph M020.
- GRASE and limits: Bemotrizinol is proposed GRASE for ages 6 months and older at concentrations up to 6% (FDA materials).
- Manufacturer & timing: DSM‑Firmenich plans to market it as Parsol Shield; commercial rollout is expected in 2026 with a public comment period open through Jan. 26, 2026 (FDA press announcement).
- Performance & safety: Independent reviews find photostable, broad UVA/UVB protection with low systemic absorption and low irritation rates (NIH / PubMed Central review).
What the FDA has done
On Dec. 11–12, 2025 the agency posted an OTC Monograph Order Request (OTC000039) proposing to amend Monograph M020 to allow bemotrizinol as an active ingredient in over‑the‑counter sunscreens. This marks the first proposed addition of a sunscreen active under the monograph process in roughly 26 years — a change explored in legal analyses such as the Holland & Knight overview.
Evidence the agency cites
FDA materials summarize toxicology, clinical pharmacokinetic, and irritation studies indicating that bemotrizinol offers broad UVA and UVB protection, is photostable, shows low systemic absorption, and rarely causes skin irritation. These points are echoed in independent literature (NIH / PubMed Central review).
DSM’s role and the request to FDA
The application to the FDA came from DSM Nutritional Products LLC (now operating as DSM‑Firmenich), filed Sept. 23, 2024 as an OTC Monograph Order Request seeking GRASE recognition for bemotrizinol at up to 6% (FDA filing; see legal discussion at Holland & Knight).
Commercial plans: DSM plans to market bemotrizinol as Parsol Shield in the U.S.; press reports (Associated Press) indicate a 2026 launch and an estimated exclusivity window of about 18 months, though that exclusivity appears in company and news reporting rather than the monograph text.
Conditions of use under the proposed order
If finalized, the order would permit bemotrizinol at up to 6% in many OTC forms — oils, lotions, creams, gels, butters, pastes, ointments, sticks and certain sprays. For sprays, the FDA specifies they must be formulated without a propellant or packaged so the propellant does not contact the formulation (AFS Law alert; Holland & Knight).
Bemotrizinol may be combined with other sunscreen actives and skin protectants provided all monograph requirements are met.
Safety and pharmacokinetics
Toxicology and human studies reviewed by the FDA and independent researchers show low systemic exposure when bemotrizinol is applied to skin. Clinical pharmacokinetic work found plasma levels rarely exceeded the FDA screening cutoff of 0.5 ng/mL — a threshold that, if crossed, would prompt broader toxicity testing (NIH / PubMed Central review).
Adverse effects reported in the literature are few and mostly mild. International regulators have allowed higher maximum concentrations — up to 10% in some regions — while Canada has set a 6% limit; the FDA’s proposed 6% cap aligns with the company’s request and some foreign rules (PMC review).
Efficacy, stability and comparison to older filters
Bemotrizinol is a member of a newer class of UV filters used widely outside the U.S., alongside filters such as bisoctrizole and drometrizole trisiloxane. These modern filters provide broad UVA/UVB coverage and superior photostability, retaining protective power under sunlight better than some older filters — making them valuable in high‑SPF and long‑lasting formulas (NIH / PubMed Central review).
Regulatory context: why this matters now
The U.S. list of GRASE sunscreen actives has not meaningfully expanded since the late 1990s; the deemed final order carried forward 16 actives from 1999. Many dermatologists and legal analysts contend that limited updates left U.S. consumers with fewer modern options than those in Europe, Australia and parts of Asia (FDA Q&A; PMC review).
The OMOR pathway was created to speed review of ingredients like bemotrizinol and better align the U.S. with global standards. FDA officials have signaled urgency: Commissioner Marty Makary has said the agency historically moved too slowly on sunscreens, and Karen Murry, MD, called bemotrizinol “a welcome addition,” expressing hope for faster access to other new ingredients (FDA press materials).
Timeline, comment period and next steps
The FDA opened a public comment period on the proposed order through Jan. 26, 2026. After the comment period the agency will review feedback and decide whether to issue a final administrative order adding bemotrizinol to Monograph M020 (FDA proposal page; Holland & Knight analysis).
Some analysts projected a possible GRASE determination by March 2026, but final timing will depend on public comments and any additional data requests (PMC literature).
Implications for the Imperial Valley, California
The Imperial Valley’s large agricultural economy and outdoor workforce could see direct benefits if more photostable, broad‑spectrum sunscreens reach the U.S. market. Employers, clinics and public‑health programs may begin adopting newer products to reduce sunburn and long‑term skin damage among farmworkers and outdoor laborers.
Economic: Local retailers and pharmacies could gain new inventory opportunities when Parsol Shield and other bemotrizinol formulas launch.
Political & programmatic: County and public‑health leaders focused on worker safety may expand sun‑safety programs, partnering with employers to distribute sunscreen and shade solutions; potential FDA modernization could enter regional labor‑health discussions.
Social & cultural: Residents who spend long hours outdoors — migrant workers, farmhands, recreationists — may benefit from sunscreens that better withstand heat and sweat. Community clinics serving low‑income populations will need guidance on affordability and efficacy, and outreach programs could promote use among families with infants 6 months and older per the FDA’s proposed age guidance.
Practical guidance: For clinicians, occupational‑health programs and employers in the region, the proposal signals potential new product options. Continue to emphasize layered sun protection — sunscreen combined with hats, long sleeves, shade, and scheduling to avoid peak sun — since sunscreen remains one part of a broader prevention strategy (FDA Q&A).
Sources and further reading
- FDA press announcement — Bemotrizinol proposed order
- NIH / PubMed Central review on modern UV filters and bemotrizinol
- Holland & Knight analysis of the proposed new active
- AFS Law alert on the proposed addition
- FDA Q&A on the sunscreen monograph process
“Bemotrizinol is a welcome addition,” said Karen Murry, MD, acting director of the FDA’s Office of Nonprescription Drugs — reflecting agency interest in modernizing access to safe, effective sunscreens.
