US approves first new sunscreen ingredient in two decades as FDA clears bemotrizinol

The US Food and Drug Administration (FDA) has approved a new sunscreen ingredient for the first time in over two decades.

The ingredient, known chemically as bemotrizinol (or BEMT), has been added to the over-the-counter sunscreen monograph. Dermatologists have praised the decision, saying it will finally give American consumers access to a safer, highly advanced, and more effective option for protection against harmful ultraviolet (UV) rays.

Closing the 'UVA protection gap'

For more than 25 years, the US sunscreen market has lagged behind Europe, Asia, and Australia, where formulators have access to roughly 30 different UV filters. Prior to this ruling, US manufacturers were limited to just 15 filters.

While existing US chemical sunscreens efficiently block UVB rays (the primary cause of sunburns), they struggle to adequately block UVA rays, which penetrate deeper into the skin, causing premature ageing, DNA damage, and skin cancer.

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Why bemotrizinol is a game-changer

Dermatologists and cosmetic scientists consider bemotrizinol to be vastly superior to older US chemical filters like avobenzone, which notoriously breaks down quickly when exposed to sunlight and can cause skin irritation.

Unlike older filters, bemotrizinol is incredibly stable and does not degrade rapidly under the sun, meaning its protective shield lasts significantly longer on the skin.

Mineral-based blocks like zinc oxide offer broad protection but leave a chalky, white residue. Bemotrizinol is a non-mineral filter that goes on completely clear, blending seamlessly into all skin tones.

Because it has a larger molecular structure and higher molecular weight than older chemical filters, bemotrizinol sits safely on top of the skin rather than absorbing heavily into the bloodstream.

The FDA’s safety review included a multiyear animal study and reproductive testing, which concluded that the ingredient is completely non-irritating and safe for adults and children aged 6 months and older.

When will it hit US shelves?

The ingredient will initially enter the US market under a proprietary formulation called Parsol Shield, manufactured by DSM Nutritional Products, which has been granted an 18-month exclusivity period. Consumers can expect to see the first wave of upgraded, bemotrizinol-infused sunscreens hitting American store shelves by the end of the year.