FDA proposes adding sunscreen ingredient commonly used in other parts of the world to list of permitted products
Many sunscreen products in Australia and Europe
By Deidre McPhillips, CNN
(CNN) — A new proposal from the US Food and Drug administration would allow sunscreens in the United States to include an active ingredient already commonly used in Europe, Australia 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,” according to a news release from the FDA on Thursday.
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 recognized as safe and effective” for their intended use. Identifying and assessing active ingredients is a key part of GRASE framework.
The European company 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 on Thursday.
The FDA has opened the request to public comments, and will conduct a safety and effectiveness assessment under the GRASE framework before determining if the agency will 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 come from the sun, as well as tanning beds or sun lamps. Staying in the shade, 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.
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