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FDA Sunscreen Ingredient Approval

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The FDA approved bemotrizinol as the first new sunscreen active ingredient permitted in the U.S. market in over 25 years. The ingredient, previously used safely in Europe since 1999, will be marketed as Parsol Shield with an 18-month exclusivity period.

2 reported locations
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  1. Washington, District of Columbia, United States
  2. United States

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2026-08-16 to 2026-11-13 · UTC publication dates

Coverage begins 10 Jun, 02:06 UTC

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What happened

The facts
  1. FDA approves bemotrizinol as first new sunscreen ingredient in over 25 years

    The U.S. Food and Drug Administration approved bemotrizinol on Tuesday, June 9, 2026, marking the first approval of a new sunscreen active ingredient in more than 25 years. Bemotrizinol is a broad-spectrum ultraviolet filter that protects against both UVA and UVB rays while causing minimal skin irritation and absorption. The ingredient has been safely used in Europe since 1999 but was not previously authorized for use in the United States.

    1 corroborating report

  2. Bemotrizinol to be marketed under brand name Parsol Shield by DSM Nutritional Products

    Dutch manufacturer DSM Nutritional Products will initially sell bemotrizinol in the United States under the brand name Parsol Shield, with an expected launch later in 2026. The product will have an 18-month exclusivity period before other manufacturers are permitted to use the ingredient.

    1 corroborating report

  3. Bemotrizinol first ingredient approved under streamlined FDA process from 2020

    Bemotrizinol is the first sunscreen ingredient to be approved through a streamlined approval process authorized by Congress in 2020, designed to expedite the updating of FDA's lists of safe nonprescription drug ingredients. Bemotrizinol was originally filed with the FDA for review in 2005 after receiving authorization from European authorities in 1999.

    1 corroborating report

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