US clears first new sunscreen filter in over two decades
New CapabilitiesAn FDA order lets sunscreen makers start using bemotrizinol, a UVA-and-UVB filter sold in Europe since 1999.
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Overview
For more than 25 years, US sunscreen makers worked from the same short list of ultraviolet filters. On August 9, 2026, an FDA order let them start using a new one.
The filter, bemotrizinol, blocks both UVA and UVB rays and stays stable in sunlight. It has protected skin in Europe and Asia since 1999. Now it can go into Neutrogena, Aveeno, and other US brands.
Why it matters
Americans gain access to a stronger, more stable broad-spectrum filter that has guarded European and Asian skin for 25 years.
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Organizations Involved
The agency regulates US sunscreens as over-the-counter drugs, a stricter path than the cosmetic rules used in Europe.
The company sells bemotrizinol to sunscreen makers under the brand name Parsol Shield.
Kenvue owns Neutrogena and Aveeno, two of the largest US sunscreen brands.
Timeline
January 2005 August 2026
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Filter becomes usable in US products
Today MilestoneThe FDA order takes effect. Manufacturers may now legally add bemotrizinol, though finished products will reach shelves later.
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FDA declares bemotrizinol safe and effective
RegulatoryThe agency issues its final order classifying the filter as safe and effective for adults and children six months and older.
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Sunscreen Innovation Act becomes law
LegislationCongress passes a law to speed FDA review of new sunscreen filters, targeting a backlog of eight pending applications.
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First US application filed
RegulatoryCiba Specialty Chemicals asks the FDA to allow bemotrizinol in US sunscreens. The request then stalls for years.
Historical Context
3 moments from history that rhyme with this story — and how they unfolded.
Europe clears bemotrizinol (1999)
European regulators approved bemotrizinol for sunscreens, treating it as a cosmetic ingredient. Brands sold it under names including Tinosorb S and Parsol Shield. It became a common broad-spectrum filter across Europe and Asia.
European sunscreens gained a stable filter with strong UVA coverage well before US shoppers could buy it.
A widening gap opened between US and international sunscreen formulas that lasted more than 25 years.
The 27-year lag shows how differently the US and Europe regulate the same ingredient. Bemotrizinol was routine abroad long before the FDA cleared it.
Sunscreen Innovation Act (2014)
Congress passed a law to force faster FDA review of new sunscreen filters. Eight applications were stuck, some pending for over a decade. Lawmakers set deadlines for the agency to act.
The FDA issued proposed orders but found the safety data insufficient to clear the pending filters.
No new filter reached the market for another decade, showing that a deadline alone could not resolve the FDA's data demands.
Bemotrizinol is the first filter to clear the process the 2014 law tried to speed up. It shows what it finally took to get one through.
FDA proposed sunscreen rule (2019)
The FDA proposed rules asking for more safety data on common chemical filters after studies showed some, like oxybenzone, were absorbed into the bloodstream. The agency wanted to know what that absorption meant.
The proposal left the safety status of several older filters unsettled and raised the bar for new ones.
Blood absorption became a central test for any filter seeking US approval.
Bemotrizinol cleared that bar. Its very low absorption into the bloodstream was central to the FDA's safe-and-effective ruling.
