FDA-Approved Sunscreen Filter Bemotrizinol Debuts in New US Products

The FDA added bemotrizinol to its OTC sunscreen monograph in June 2026, permitting the ingredient in US sunscreen formulations at concentrations up to 6%. The action, finalized 7 months after the ingredient's initial proposal, came through the CARES Act's administrative order pathway.¹

FDA officials, including acting director Mike Davis, MD, PhD, said bemotrizinol is "generally recognized as safe and effective for adults and children aged 6 months and older.” The approval drew a statement from Health and Human Services (HHS) Secretary Robert F. Kennedy Jr., who tied it to the administration's broader health agenda.¹

"As promised in the Trump administration's MAHA Strategy Report, HHS is advancing innovation by bringing a new sunscreen ingredient to the US market for the first time in 20 years," Kennedy said.¹ "Bemotrizinol has been used safely in Europe for decades, and FDA's action will increase competition and consumer confidence in sunscreen products."

Bemotrizinol is an oil-soluble organic chemical ultraviolet (UV) filter that provides broad-spectrum UVA/UVB protection and does not leave the visible white residue associated with mineral sunscreens.¹

It is photostable, meaning it resists breaking down quickly under sunlight, and its larger molecular size corresponds with low levels of skin absorption. The ingredient has been used safely in Europe, Australia, and Asia for decades, and its US approval marks the first new sunscreen ingredient permitted domestically since the late 1990s.¹

Parsol Shield Manufacturer Highlights Regulatory Milestone

dsm-firmenich announced that its Parsol Shield (bemotrizinol) has been approved for the US market, calling it the first new sunscreen active approved in the United States in more than 25 years under modernized generally recognized as safe and effective (GRASE) and MUsT evaluation guidelines. Clinical studies supporting the approval involved nearly 500 participants representing the diversity of the US population and demonstrated what the company described as exceptional UV efficacy, tolerability, and safety.²

"PARSOL Shield approval represents an important step forward not only for dsm-firmenich but for the future of sun protection in the US. This milestone reflects years of scientific leadership, regulatory collaboration, and commitment to bringing meaningful innovation to consumers,” Parand Salmassinia, JD, president of Beauty & Care at dsm-firmenich, said in a news release.²

Jochen Klock, DSc, director of global regulatory affairs for the company's Beauty & Care division, called the approval "a landmark step for sun protection in the United States" that "closes a longstanding innovation gap in the US. sunscreen market and reflects a modern scientific and regulatory standard that can help expand access to advanced UV protection for American consumers."²

Ultra Violette Becomes First Brand to Launch With Bemotrizinol

Ultra Violette said it is the first brand in the US to launch a sunscreen containing bemotrizinol, introducing Unblock Screen SPF 50 Breakout-Friendly Skinscreen. The product combines bemotrizinol with Bix'Activ, which the brand says helps control excess oil and blur the appearance of pores, and Pentavitin, a plant-based extract intended to support hydration for up to 72 hours. It is packaged in a touchless, press-and-play airless jar.³

"This is such a win for the US consumer. It broadens the range of SPF formats available, allows for more elegant, cosmetically pleasing textures, and supports the kind of robust protection that matters for overall skin health, including skin cancers, skin aging, melasma, and pigmentation," Ava Matthews, co-founder of Ultra Violette, said in a news release.³ "I am hopeful that BEMT's categorization of GRASE is also going to help shift the broader conversation around chemical sunscreens, which are so often unfairly stigmatized despite all their many benefits.”

Co-founder Bec Jefferd said the company has developed bemotrizinol-based products in its global range for close to 10 years, which she said allowed it to move quickly once the ingredient cleared FDA review.

"We are incredibly proud to be the first to bring our SPF products formulated with bemotrizinol to Sephora and the wider US market," Jefferd said in a news release, pointing to a pipeline of additional bemotrizinol products "starting with the highly anticipated launch of Fave Screen in January 2027."³

That follow-up product, Fave Screen SPF 50, is described as an ultralight, brightening milky sunscreen powered by 5% bemotrizinol alongside niacinamide and vitamins C and E. Ultra Violette was founded in Australia in 2019 by Matthews and Jefferd, entered the US market in 2025, and is sold at Sephora locations across the US, UK, and Australia.³

Pharmacist Counseling Points for New Sunscreen Filters

As bemotrizinol-based products reach US shelves, standard sun safety counseling still applies. Pharmacists advise applying 1 oz of sunscreen 15 to 30 minutes before sun exposure and reapplying every 2 hours or immediately after swimming or sweating. Sunscreen should also be stored away from direct heat and sunlight to preserve its effectiveness.¹

For pharmacists, a chemical filter with a different molecular profile than older options gives them a new talking point when patients ask about formulation, tolerability, or the difference between chemical and mineral sunscreens. As more brands add bemotrizinol to their lineups in the months ahead, pharmacists may field more questions about product availability and how the new filter compares with existing options.

REFERENCES

1. Gallagher A. FDA approves bemotrizinol as an OTC sunscreen ingredient. Drug Topics. June 9, 2026. Accessed September 1, 2026. https://www.drugtopics.com/view/fda-approves-bemotrizinol-as-an-otc-sunscreen-ingredient

2. PARSOL Shield approved by FDA, dsm-firmenich setting a new era for U.S. sun protection. News release. dsm-firmenich. September 1, 2026. Accessed September 1, 2026. https://prnmedia.prnewswire.com/news-releases/parsol-shield-approved-by-fda-dsm-firmenich-setting-a-new-era-for-us-sun-protection-302864381.html

3. Ultra Violette becomes first brand in the US to launch a sunscreen containing newly FDA-approved filter bemotrizinol. News release. Ultra Violette. August 31, 2026. Accessed September 1, 2026. https://prnmedia.prnewswire.com/news-releases/ultra-violette-becomes-first-brand-in-the-us-to-launch-a-sunscreen-containing-newly-fda-approved-filter-bemotrizinol-302865398.html