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New Sunscreen Rules Take Effect for Large-Scale Manufacturers

The FDA’s final rule for sunscreen labeling requirements took effect in December 2012, an enactment that affects the manufacturers of sunscreen products with annual sales of more than $25,000.

The FDA first announced plans for changes to the wording of sunscreen rules and to the testing processes that some sunscreens undergo in June 2011. The changes were originally supposed to take effect in June 2012, but the deadlines were pushed back by 6 months for large sunscreen manufacturers to December 17, 2012. Smaller companies that manufacture sunscreen still have until December 2013 to comply with the testing and labeling changes.

The final rule that took effect in December for large-scale sunscreen manufacturers calls for products to pass some new broad-spectrum tests; products that pass these tests will be allowed to make claims related to skin cancer protection and early skin aging. Products that are not deemed broad spectrum must include a warning that the product can only protect against sunburn, not skin cancer or photoaging. The new rules also prohibit manufacturers from claiming a sunscreen is “waterproof” or “sweatproof.”

For more information on the new sunscreen rules, please visit”


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