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FDA Proposes New Rule To Ensure Safety, Effectiveness Of Sunscreen Products

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US health regulators are seeking changes that will make it easier for consumers to find safe and effective sunscreen products.

The U.S. Food and Drug Administration announced on Thursday it is proposing new regulations that aim to improve the safety and effectiveness of sunscreen products.

Safety Of Ingredients Used In Sunscreen Products

There are concerns that some ingredients used in sunscreen products could be hazardous to humans, and the proposed rules would classify ingredients as "generally recognized as safe and effective" or GRASE. These are ingredients that do not require approval from the FDA to be marketed.

Under the new proposal, only two — zinc oxide and titanium dioxide — of the 16 active ingredients in sunscreens would be considered GRASE. PABA and trolamine salicylate would not be classified as GRASE due to safety concerns.

The 12 other ingredients, namely meradimate, ensulizole, homosalate, octisalate, octocrylene, padimate O, sulisobenzone, oxybenzone, octinoxate, cinoxate, dioxybenzone, and avobenzone do not have enough data to determine if they can be classified as GRASE. The FDA is asking the sunscreen industry to provide more evidence so it can evaluate the safety and effectiveness of these ingredients.

Other Proposed Changes

The proposed new rule also includes updates on which products can be marketed broad spectrum and what information should be included in the labels of the products.

High SPF numbers may not also be allowed. The proposed new rule suggests a cap of "60+" and a hard limit of 80. While higher SPF may work better, there is controversy about whether or not the numbering system is reliable enough to make a meaningful difference for consumers.

"Today's action is an important step in the FDA's ongoing efforts to take into account modern science to ensure the safety and effectiveness of sunscreens," FDA Commissioner Scott Gottlieb said in a statement. "The proposal we've put forward would improve quality, safety and efficacy of the sunscreens Americans use every day."

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