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FDA Expands Sunscreen Options with First New Chemical UV Filter in Decades

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The U.S. Food and Drug Administration (FDA) has approved bemotrizinol as a new active ingredient for use in sunscreens. This marks the first approval of a new chemical UV filter in the United States in approximately 20 to 30 years.

Key Properties of Bemotrizinol

Bemotrizinol is a chemical UV filter that provides broad-spectrum protection by blocking both UVA and UVB rays. The ingredient is described as photo-stable, meaning it degrades more slowly in sunlight compared to existing chemical filters like avobenzone. According to FDA data, the compound has low absorption into the body. It is also reported to be non-irritating and transparent on the skin, which enables the formulation of less greasy sunscreens that leave less visible residue.

This marks the first approval of a new chemical UV filter in the United States in approximately 20 to 30 years.

Background and Regulatory Context

Current FDA-approved chemical sunscreens in the US generally protect against either UVA or UVB rays, but not both. Mineral sunscreens using zinc oxide or titanium dioxide are broad-spectrum but can leave a white residue. Bemotrizinol has been used as an ingredient in sunscreens in Europe, Australia, and parts of Asia for years.

The approval process took place over two decades due to the FDA's classification of sunscreens as over-the-counter drugs, which requires rigorous safety and efficacy testing. The European company DSM-Firmenich disclosed it invested at least $18 million over more than 20 years to obtain approval for the ingredient.

Availability and Market Rights

DSM-Firmenich holds exclusive U.S. marketing rights for bemotrizinol under the brand name Parsol Shield for a period of 18 months. First consumer products containing the ingredient are expected to be available on store shelves around September.

Statements from Experts and Organizations

  • David Andrews, chief science officer of the Environmental Working Group, stated that the approval improves UVA protection for US consumers.
  • Dr. Heather Rogers, a dermatologist, called the approval "a very big deal" and noted bemotrizinol "hits every box."
  • Kelly Dobos, a cosmetic chemist, stated the ingredient should lead to more aesthetically pleasing sunscreens.
  • Alexa Friedman, a senior scientist at the Environmental Working Group, emphasized the availability of safety data and the ingredient's non-irritating properties.

"This is a very big deal." — Dr. Heather Rogers, dermatologist