12 June, 2026 15:19:05 IST 
The US Food and Drug Administration (FDA) has approved bemotrizinol as a permitted active ingredient in over-the-counter sunscreen products — the first addition to the country's sunscreen monograph since the late 1990s.
The agency finalised the decision on 9 June 2026, seven months after issuing its proposed order in December 2025. The approval covers concentrations up to 6% and extends to adults and children aged six months and older.
Global nutrition, health, and beauty major, DSM-Firmenich, which filed the request to add bemotrizinol to the OTC monograph, will initially market it in the US under the brand name Parsol Shield, with launch expected later this year. Other manufacturers may begin incorporating bemotrizinol from 9 August 2026, following an 18-month exclusivity period for DSM-Firmenich. As per the company, clinical studies involving nearly 500 participants demonstrated broad-spectrum UV efficacy, tolerability, and a strong safety profile for the ingredient.
The approval addresses a longstanding gap in the US sunscreen market. Sunscreens on US store shelves are said to excel at blocking the radiation that causes visible sunburns, called ultraviolet B rays. However, critics say they routinely fail to shield against deep-penetrating ultraviolet A, or UVA rays, which drive premature aging, suppress the immune system and are the primary contributor to skin cancer, according to the American Cancer Society.
Research by the Environmental Working Group (EWG) - a nonprofit health and environmental advocacy organisation - has found that US sunscreens deliver on average just 24% of the UVA protection implied by their SPF labelling. In 2019, US FDA scientists flagged six widely used chemical sunscreen ingredients — including homosalate and oxybenzone — as potentially entering the bloodstream at unsafe levels after a single day's use. Those ingredients remain on shelves pending manufacturer-funded safety studies that have yet to be submitted.
Bemotrizinol has been in use in Europe since 2000 and is also approved in Australia. It provides broad-spectrum protection against both UVA and UVB radiation, is highly photostable, and shows low absorption through the skin into the bloodstream — a concern that has dogged older chemical filters. Unlike avobenzone, currently the only non-mineral UVA filter available in the US, bemotrizinol does not break down under sun exposure. It can also be combined with zinc oxide without the pronounced white cast associated with mineral-only formulations. For formulators, the ingredient enables lightweight textures and, being already approved across multiple regions, simplifies development of globally scalable sunscreen formulations.
Mr. David Andrews, EWG's chief science officer, said the approval would "help close the UVA protection gap in US sunscreens," adding that Americans had "used outdated sunscreen tech while the rest of the world moved forward."
Ms. Parand Salmassinia, Beauty & Care President at DSM-Firmenich, said the approval "builds on years of scientific leadership and regulatory excellence, while helping address a longstanding innovation gap in the market."
The Personal Care Products Council welcomed the decision but called on the FDA to accelerate approval pathways for additional sunscreen actives.
Bemotrizinol is the first ingredient cleared under the streamlined administrative order process enacted by Congress in 2020.
