US proposes major change to sunscreen regulations

Friday, 12 December 2025 09:20

The change would allow sunscreens in the US to include an active ingredient already commonly used in Australia.

A new proposal from the US Food and Drug administration would allow sunscreens in the US to include an active ingredient already commonly used in Australia, Europe, and parts of Asia.

Bemotrizinol is a chemical that provides broad-spectrum protection against both ultraviolet A and B rays. It "has low levels of absorption through the skin into the body, and rarely causes skin irritation," the FDA said in a news release today.

The FDA regulates the safety and effectiveness of sunscreens. New products can be brought to market through an over-the-counter drug review process that sets conditions about how and when they are "generally recognised as safe and effective" for their intended use. Identifying and assessing active ingredients is a key part of the GRASE framework.

A thoughtful elderly woman applies sunscreen to her husband's arms and shoulders to shield his skin.

DSM Nutritional Products LLC, with headquarters in both Switzerland and the Netherlands, has submitted a request that the FDA add bemotrizinol as a new active ingredient permitted for use in sunscreens in the US, the FDA said.

The FDA has opened the request to public comments and will conduct a safety and effectiveness assessment under the GRASE framework before determining whether to issue a final order to add bemotrizinol to the active ingredient list for sunscreens.

"Bemotrizinol would be a welcome addition to the current array of effective sunscreen active ingredients already available to American consumers" Dr Karen Murry, acting director of the Office of Nonprescription Drugs, said in a statement.

The majority of skin cancers are caused by too much exposure to ultraviolet radiation, which comes from the sun as well as tanning beds or sun lamps.

Staying in the shade and wearing UV-protective clothing, hats and sunglasses can all reduce exposure, but sunscreens, chemical or mineral, are also important tools to protect skin.

Chemical sunscreens – such as avobenzone, oxybenzone, octocrylene, ecamsule, homosalate, octisalate and octinoxate – bind to the top layer of skin and transform UV rays into heat that disperses. Mineral sunscreens, such as zinc oxide and titanium dioxide, form a protective barrier between the skin and the sun.

DOWNLOAD THE 9NEWS APP: Stay across all the latest in breaking news, sport, politics and the weather via our news app and get notifications sent straight to your smartphone. Available on the Apple App Store and Google Play.