• FDA proposes new sunscreen regulations

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    The U.S. Food and Drug Administration could soon add new regulations for most over-the-counter sunscreen products.

    In a news release, the agency says the move is "aimed at bringing nonprescription, over-the-counter sunscreens that are marketed without FDA-approval applications up to date with the latest science to better ensure consumers have access to safe and effective preventative sun care options."

    The proposal would raise the maximum SPF labeling on products from 50+ to 60+, based on new evidence of some clinical benefits of additional SPF. Any products rated as SPF 15 or greater will need to provide protection against UVA and UVB rays.


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    "Since the initial evaluation of these products, we know much more about the effects of the sun and about sunscreen’s absorption through the skin," FDA Commissioner Scott Gottlieb, M.D., said in a statement.

    Changes could also be made to product labels. The proposal would require the maker of the product to show active ingredients on the front of the package to bring sunscreen in line with other OTC drugs as well as a notification on the front label for consumers to read the skin cancer/skin aging alert for sunscreens that have not been shown to help prevent skin cancer; and revised formats for SPF, broad spectrum and water resistance statements.

    “The proposal we’ve put forward would improve quality, safety and efficacy of the sunscreens Americans use every day. We will continue to work with industry, consumers and public health stakeholders to ensure that we’re striking the right balance," Gottlieb said.

    Before a ruling is made on this proposal, the FDA wants to hear from you. The agency is seeking public comment it works toward developing a final rule. 


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