FDA approves bemotrizinol, a new U.S. sunscreen filter, marking first addition in decades
The FDA on June 9, 2026, added bemotrizinol to the OTC sunscreen monograph, the first chemical sunscreen filter approved in nearly 30 years—clearing use at up to 6% for adults and children 6 months and older and enabling new formulations.
Key takeaways
- Ingredient: bemotrizinol (BEMT), now GRASE for OTC sunscreens.
- Use limits & age: Approved at up to 6%, for adults and children 6 months and older.
- Market: First U.S. commercial name PARSOL Shield from DSM, with ~18 months limited exclusivity.
- Regulatory milestone: Final administrative order issued June 9, 2026, via the OMOR pathway—first new chemical filter added in decades.
What the FDA did
On June 9, 2026, the FDA issued a final administrative order adding bemotrizinol to the over‑the‑counter sunscreen monograph (M020). That action makes bemotrizinol a permitted active ingredient under monograph rules—avoiding individual NDA requirements so long as manufacturers meet testing, labeling, and facility registration obligations. See the FDA press release and the earlier FDA proposed order.
Who requested this and what is PARSOL Shield?
Dutch ingredient maker DSM Nutritional Products filed a Tier 1 OMOR on Sept. 23, 2024, requesting approval of bemotrizinol at up to 6% in sunscreens. DSM plans to commercialize the active in the U.S. as PARSOL Shield, with product launches expected in late 2026. DSM will have a limited exclusivity window—about 18 months—before other manufacturers may market bemotrizinol under the monograph. (Background and timeline: HK Law; industry note: Diaz Trade Law.)
Why this matters
The U.S. sunscreen monograph recognized multiple filters in a 1999 final rule, but few modern filters used internationally made it to the U.S. market—creating what experts called regulatory inertia. Bemotrizinol’s approval is a regulatory milestone that modernizes options for consumers and formulators, potentially improving sunscreen efficacy and cosmetic acceptability. Context and analysis: scientific review and consumer outlook.
FDA messaging
“The agency historically moved too slowly — Americans deserved timely access to safe and consumer‑friendly over‑the‑counter products,” said FDA Commissioner Marty Makary, MD, MPH. Karen Murry, MD, acting director of the Office of Nonprescription Drugs, called bemotrizinol a useful addition and signaled faster action on future actives.
Scientific profile of bemotrizinol
Bemotrizinol is a broad‑spectrum chemical filter that absorbs both UVA and UVB radiation. It is highly photostable and oil‑soluble, enabling less greasy formulations with reduced white cast. The FDA reviewed clinical pharmacokinetic and safety data showing low systemic absorption and rare irritation at 6% use; one clinical study reported plasma levels rarely exceeding the FDA reference threshold of 0.5 ng/mL. International limits vary (EU permits up to 10%; Canada allows 6%). For scientific context, see the PMC review and FDA materials (FDA press release).
Formulation flexibility
Bemotrizinol mixes well with other filters, including mineral filters such as zinc oxide and titanium dioxide, allowing brands to develop higher‑SPF, photostable, and cosmetically refined products. The FDA’s final order allows bemotrizinol in lotions, creams, gels, sticks and certain spray formats.
Regulatory details and manufacturer obligations
GRASE status under the OTC monograph does not remove other requirements. Products using bemotrizinol must meet monograph conditions: accurate SPF and broad‑spectrum testing, proper Drug Facts labeling, registered manufacturing facilities, and required FDA drug listing before shipping. Importers must ensure foreign formulations comply to avoid border holds. Legal commentary urges strict adherence to testing and labeling processes. (Compliance guidance: Diaz Trade Law; FDA monograph info: FDA Q&A on monograph.)
Timeline and next steps
- Sept. 23, 2024: DSM filed Tier 1 OMOR for bemotrizinol. (HK Law timeline)
- Dec. 2025: FDA issued proposed order and opened public comment. (FDA proposed order)
- June 9, 2026: FDA issued final order adding bemotrizinol as GRASE. (FDA final order)
DSM expects PARSOL Shield on the U.S. market in late 2026; other brands likely to follow after the ~18‑month exclusivity period, with broader product availability in 2027 and beyond. (Market outlook: Diaz Trade Law; HealthCentral.)
Relationship to broader policy
Lawmakers and public‑health advocates pushed for faster monograph updates. The SAFE Sunscreen Standards Act (late 2025) and the OMOR pathway—used here—aim to speed access to modern filters. Bemotrizinol’s approval may encourage applications for other internationally used filters such as bisoctrizole and drometrizole trisiloxane.
Implications for the world
Economic: U.S. market demand could reshape global supply chains as manufacturers ramp production and brands reformulate. DSM’s PARSOL Shield launch may boost raw‑ingredient demand and export opportunities.
Political: Other regulators monitor FDA actions closely; U.S. approval may reduce non‑tariff barriers and ease trade for international personal‑care firms.
Social & cultural: More elegant, less greasy sunscreens may increase use, improve protection—especially for darker skin tones—and influence beauty norms worldwide.
Practical applications for consumers and businesses
Consumers should not expect an immediate flood of new products. DSM targets late‑2026 launch for PARSOL Shield; other brands will follow after exclusivity ends. Continue following sun‑safety guidance: use broad‑spectrum sunscreen (FDA minimum SPF 15; many experts recommend SPF 30+), apply liberally, reapply every two hours, wear protective clothing and seek shade during peak sun. Manufacturers and importers must complete required testing, labeling and registration before shipping.
Sources and further reading
- FDA press release: FDA expands sunscreen options for the first time in 20 years
- FDA proposed order: FDA proposes expanding sunscreen active ingredient list
- Scientific review and background (PMC)
- Legal and industry analysis (Diaz Trade Law)
- Industry timeline and commentary (HK Law)
- Consumer outlook (HealthCentral)
- FDA Q&A on OTC sunscreen monograph requirements
