FDA Approves Bemotrizinol, First New Sunscreen Ingredient in 25 Years

The FDA finalized its approval of bemotrizinol on Tuesday, June 9, 2026, the first new active sunscreen ingredient cleared for the U.S. market in more than 25 years. Sold under the brand name Parsol Shield by dsm-firmenich, the chemical is a broad-spectrum ultraviolet filter long used in Europe and Asia.

The agency signed off through a streamlined process authorized by the 2020 CARES Act, ending a regulatory wait that began with the ingredient’s first FDA application in 2005. Dsm-firmenich will hold 18 months of exclusive U.S. marketing rights before other formulators can add the filter to their products. The approval closes a long-standing gap between the U.S. and Europe, where the same filter has been in continuous use since 1999.

What Bemotrizinol Does That Current US Filters Don’t

Bemotrizinol is what sunscreen chemists call a broad-spectrum filter, meaning it absorbs both UVB rays, the shorter wavelengths that cause sunburn, and UVA rays, the longer ones tied to premature aging, immune suppression, and most skin cancers. U.S. sunscreens have largely cobbled together broad-spectrum coverage by mixing two or more single-action chemicals, since the older non-mineral UVA and UVB filters on the U.S. market protect against one or the other. Mineral filters, zinc oxide and titanium dioxide, cover the full spectrum on their own, but leave a chalky white residue that many consumers, especially people of color, avoid. Bemotrizinol handles both ranges in a single molecule and, at the FDA-permitted 6% concentration, stays largely on the surface of the skin.

Where older non-mineral UVA filters break down in sunlight, bemotrizinol is photo-stable, holding its protection as the sun beats down on it. Data submitted to the FDA showed absorption levels below the concentration the agency treats as indicative of systemic exposure. Skin irritation tests at permitted concentrations found no meaningful irritation.

For decades, Americans have used outdated sunscreen tech while the rest of the world moved forward. The approval of bemotrizinol will help change that. The FDA’s go-ahead will finally bring more effective, safer sun protection to American store shelves.

David Andrews, chief science officer at the Environmental Working Group, has pushed the FDA since 2019 to clear the new filter, framing it as the first step toward closing a UVA protection gap that American sunscreens have carried for years. The agency agreed that the chemical offers a level of UVA protection not previously available in U.S. formulations, calling it generally recognized as safe and effective for adults and children 6 months of age and older. Dsm-firmenich described the new ingredient as a public health imperative in a March 2026 statement and said it will work with U.S. distribution partner Univar Solutions to roll it out. The FDA’s review found no meaningful skin irritation at permitted concentrations, a finding that echoed the European Union’s 1999 conclusions. Bemotrizinol is the first sunscreen chemical filter cleared through the post-2020 streamlined review process.

A 25-Year Wait Behind a Single Approval

Bemotrizinol was first authorized in the European Union in 1999, the same year the U.S. last approved a new chemical sunscreen filter, avobenzone. The original developer, the Swiss chemical company CIBA Specialty Chemicals, filed the first U.S. application in 2005. CIBA was later acquired by BASF, which now sells the filter overseas as Tinosorb S.

The 21-year gap between the 2005 filing and the June 2026 approval is not, in FDA terms, a delay. The agency classifies sunscreens as over-the-counter drugs, which subjects every new active ingredient to the same lengthy safety and efficacy review applied to nonprescription medicines. The 2019 and 2021 FDA reviews found 12 of the 16 active ingredients then on the U.S. market had insufficient safety data to be called GRASE, though the agency allowed manufacturers to keep selling them while data was gathered. The U.S. treats sunscreens as drugs, while some other countries regulate them as cosmetics.

The first 16 years of bemotrizinol’s U.S. review were governed by an older rulemaking process that agency officials have openly described as broken. The change came in 2020 with the CARES Act.

FDA Commissioner Marty Makary said the agency has historically moved too slowly in this area, leaving Americans with fewer options than consumers abroad. Karen Murry, then the acting director of the FDA’s Office of Nonprescription Drugs, called the new ingredient a welcome addition to the U.S. market and credited the CARES Act for speeding the review. The 2020 pandemic relief law replaced the agency’s slow, court-bound rulemaking with an administrative order process that lets the FDA update OTC monographs, the rulebooks for over-the-counter drugs, more quickly. The proposed sunscreen order issued in December 2025 opened a public comment period before the final approval. The reform turned what had been a 20-year wait into a roughly 21-month review for dsm-firmenich’s most recent filing, submitted Sept. 23, 2024.

The June 9 announcement is the first new sunscreen active ingredient cleared under the modernized system. Future applications from other manufacturers can use the same streamlined process. The June 9 approval closes the first sunscreen file to move through the modernized process from start to finish.

Timeline: Bemotrizinol’s path to U.S. approval

1. 1999 Bemotrizinol is authorized in the European Union; the FDA last clears a new chemical sunscreen filter, avobenzone.
2. 2005 CIBA Specialty Chemicals files the first U.S. application for bemotrizinol; the filter is later sold abroad as Tinosorb S after BASF acquires CIBA.
3. 2020 Congress passes the CARES Act, modernizing the FDA’s OTC drug review and replacing the old rulemaking process with an administrative order system.
4. September 2024 Dsm-firmenich submits its most recent application to the FDA under the new process.
5. December 2025 The FDA proposes adding bemotrizinol to the U.S. sunscreen monograph at concentrations up to 6%.
6. June 9, 2026 The FDA finalizes its approval, triggering 18 months of market exclusivity for dsm-firmenich’s Parsol Shield.

The UVA Gap American Shoppers Are Missing

Bemotrizinol’s arrival answers a question American sunscreen makers have been asking for two decades: how to bring the UVA protection of European formulas across the Atlantic. The Environmental Working Group’s peer-reviewed research found that U.S. sunscreens deliver on average just 24% of the UVA protection implied by their SPF labels, a gap that high-SPF products do not close. Most Americans reaching for high-SPF bottles are getting only a fraction of the protection they think they are buying. The May 2026 deep-dive on the new filter details how the gap developed.

UVA rays penetrate deeper than UVB, drive premature skin aging, suppress the immune system, and are the main contributor to skin cancer. Skin cancer is the most commonly diagnosed cancer in the United States, with the Melanoma Research Foundation estimating more than 200,000 cases of both types of melanoma in 2026 and more than one death per hour. Bemotrizinol’s photo-stability means it keeps absorbing UVA over hours in the sun, the technical fix the older avobenzone-only formulas could not deliver.

The new ingredient’s stability matters because avobenzone, the workhorse UVA filter in U.S. chemical sunscreens, breaks down in sunlight. Manufacturers have to pair it with stabilizers to keep it effective, and its breakdown products have been linked to allergic reactions. Bemotrizinol does not require that stabilizer scaffolding, and dsm-firmenich says it can also be paired with zinc oxide to cut the white cast that turns many consumers off mineral-only sunscreens. EWG senior scientist Alexa Friedman said bemotrizinol can be combined with zinc oxide to provide broad-spectrum protection with a lighter feel than mineral-only formulas.

The EWG will update its annual Guide to Sunscreens as bemotrizinol products reach shelves. Health and Human Services Secretary Robert F. Kennedy Jr. said in a statement that bemotrizinol has been used safely in Europe for decades and that the agency’s action will increase competition and consumer confidence in sunscreen products.

Sunscreen by the numbers

• 24% average UVA protection U.S. sunscreens actually deliver, vs. what their SPF labels imply (per peer-reviewed research from the Environmental Working Group)
• 200,000+ projected melanoma cases in the U.S. in 2026 (per the Melanoma Research Foundation)
• 515x oxybenzone’s measured blood concentration vs. the FDA’s safety threshold after a single weekend of use
• 18 months dsm-firmenich’s U.S. marketing exclusivity for Parsol Shield
• 6% maximum permitted concentration of bemotrizinol in U.S. sunscreens

From Approval to Store Shelves

The first U.S. products containing bemotrizinol will be dsm-firmenich’s Parsol Shield line, expected to reach stores later in 2026. Under the FDA’s approval order, dsm-firmenich holds 18 months of exclusive marketing rights, after which any manufacturer can incorporate the filter into its own formulations. Consumers shopping for the new sunscreens should look for “bemotrizinol,” “BEMT,” or “Parsol Shield” on the active ingredients list, or the filter’s full chemical name, bis-ethylhexyloxyphenol methoxyphenyl triazine. Dsm-firmenich said it will offer product samples, technical support, and a formulation tool to brands adopting the ingredient. The manufacturer’s March 2026 approval announcement set out the rollout timeline.

Univar Solutions, dsm-firmenich’s U.S. distribution partner, said the filter gives formulators a path to sunscreens that meet evolving consumer expectations for both protection and sustainability. The companies did not name a U.S. retail launch date for Parsol Shield-branded products. Pricing and product formats have not been disclosed.

U.S. vs. European sunscreen filter lineups

The FDA’s Broader Sunscreen Overhaul Is Still Unfinished

In 2019 and again in 2021, the FDA proposed wider reforms to U.S. sunscreen regulation, including stronger UVA standards, caps on SPF numbers, better labeling, and updated safety data requirements for older filters. None of those reforms has been finalized. Of the 16 active ingredients already on the U.S. market before bemotrizinol, 12 have insufficient safety data to be called GRASE, even though the agency has allowed them to stay on shelves. The same reviews flagged PABA and trolamine salicylate as not GRASE for safety reasons.

This approval is a triumph of consumer advocacy, but it also shines a harsh spotlight on a federal system stuck in neutral. American consumers are then left with fewer options than people in Europe and Asia have had for decades.

Melanie Benesh, vice president for government affairs at the Environmental Working Group, said the broader sunscreen reform agenda remains unfinished. Dsm-firmenich said the next step is to add products containing bemotrizinol to shelves by the end of 2026, after which the FDA’s broader reform agenda will determine how many of the filters sold in Europe and Asia can be brought to American consumers. The advocacy group plans to update its sunscreen guide as products with the new filter reach stores. The full analysis of the approval lays out the safety data and the regulatory gaps that remain.

Frequently Asked Questions

What is bemotrizinol?

Bemotrizinol is a broad-spectrum ultraviolet filter that absorbs both UVA and UVB rays. The FDA approved it on June 9, 2026, for use in U.S. sunscreens at concentrations up to 6%, making it the first new chemical sunscreen active ingredient cleared in the U.S. in more than 25 years. It has been sold in Europe and Asia since 1999 under names including Parsol Shield, Tinosorb S, AakoSun BEMT, and Escalol S.

Is bemotrizinol safe?

The FDA classified bemotrizinol as generally recognized as safe and effective (GRASE) for adults and children 6 months of age and older. The agency’s review covered a two-year animal cancer study, a multigenerational reproductive study, and skin irritation tests, all with no concerning findings. The European Union’s scientific committee reached similar conclusions when it first cleared the filter in 1999.

When will bemotrizinol sunscreens be available in the U.S.?

Dsm-firmenich said it expects products containing its Parsol Shield version of bemotrizinol to reach U.S. stores later in 2026. Under the FDA’s approval order, dsm-firmenich holds 18 months of exclusive marketing rights, after which other manufacturers may use the filter in their own formulations.

How is bemotrizinol different from existing U.S. sunscreen ingredients?

Bemotrizinol covers both UVA and UVB rays in a single molecule, is photo-stable in sunlight, stays on the skin’s surface at the FDA-permitted 6% concentration, and can be combined with zinc oxide. Avobenzone, the workhorse UVA filter in U.S. chemical sunscreens, breaks down in sunlight and requires stabilizers. Mineral filters (zinc oxide and titanium dioxide) cover the full spectrum but leave a white cast on the skin.

Why did it take more than 25 years to approve a new sunscreen filter in the U.S.?

U.S. sunscreens are regulated as over-the-counter drugs, which puts them in a slower review lane than cosmetics. The 2020 CARES Act created a faster administrative order process for OTC drug reviews, and dsm-firmenich used it to submit a fresh application on Sept. 23, 2024. The FDA finalized the approval in June 2026 under that modernized system, ending a 25-year wait for a new U.S. sunscreen chemical filter.

Disclaimer: This article is for informational purposes only and is not a substitute for professional medical advice. Sunscreen safety and effectiveness vary by individual; consult a dermatologist or other qualified health professional for personalized skin-care guidance. Figures are accurate as of June 10, 2026.