WASHINGTON (dpa-AFX) - The U.S. Food and Drug Administration has announced that it is taking action to advance sunscreen innovation, part of a broader initiative in the Office of Nonprescription Drugs. The agency is proposing to add bemotrizinol as a permitted active ingredient for use in sunscreens.
Based on the data reviewed by the FDA, bemotrizinol provides protection against both ultraviolet A and B rays, has low levels of absorption through the skin into the body, and rarely causes skin irritation. If this action is finalized, bemotrizinol will be an additional sunscreen active ingredient that the FDA considers to be generally recognized as safe and effective for use by adults and children 6 months of age and older, expanding consumer choice.
'The agency has historically moved too slowly in this area, leaving Americans with fewer options than consumers abroad. We're continuing to modernize the regulation of sunscreen and other over-the-counter drug products,' said FDA Commissioner Marty Makary.
An over-the-counter monograph drug, such as a sunscreen product, can enter the market without an approved drug application if it meets certain requirements, including conditions established in its monograph such as permitted active ingredients, uses, and doses. The FDA can modify an OTC monograph through an administrative order , and a drug company may start the process by submitting an OTC Monograph Order Request.
The FDA regulates sunscreens to ensure they meet safety and effectiveness standards. Broad spectrum sunscreens that are SPF15 or higher help prevent sunburn and reduce the risks of skin cancer and early skin aging caused by the sun, if products are used as directed with other protective measures, such as wearing protective clothing and limiting time in the sun. Given the recognized public health benefits of sunscreen use, the FDA URGED Americans to use sunscreen with other sun protective measures.
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