FDA Announces New Labeling Standards For Sunscreen

Earlier today, the Food and Drug Administration announced new labeling guidlines for sunscreen in an effort to make it clear to consumers which products offer the best chance of keeping your skin from turning into shoe leather.

As part of the new rules, sunscreens that pass the FDA’s test for protection against both ultraviolet A (UVA) and ultraviolet B (UVB) rays to be labeled as “Broad Spectrum” in addition to their SPF number.

The agency says that Broad Spectrum products with an SPF of at least 15 “will help prevent sunburn, reduce the risk of skin cancer, and reduce the risk of early skin aging,” if used regularly and as directed.

Said the director of the FDA’s Center for Drug Evaluation and Research:

FDA has evaluated the data and developed testing and labeling requirements for sunscreen products, so that manufacturers can modernize their product information and consumers can be well-informed on which products offer the greatest benefit… These changes to sunscreen labels are an important part of helping consumers have the information they need so they can choose the right sun protection for themselves and their families.

If a sunscreen with a sub-15 SPF still meets the Broad Spectrum test, it can be labeled accordingly, but its label may not state that it reduces the risk of skin cancer and early skin aging. It would also require a warning that the product has not been shown to help prevent skin cancer or early skin aging.

“Today’s announcement will take a lot of the guesswork out of reading sunscreen labels,” says Michael Hansen, Ph.D., senior scientist at our benevolent benefactor Consumers Union. “The FDA’s introduction of a broad spectrum test and associated labeling will require the sunscreen makers to first prove that their product provides such protection, and further, it will weed out the sunscreens that make broad spectrum claims without any evidence.”

The largest sunscreen makers will have one year to comply with these new rules. Those with annual sales less than $25,000 will have two years to comply.

In addition to the Broad Spectrum rule, the FDA announced a proposed rule that would limit the maximum SPF value on sunscreen labels to “50 +”. The agency says there is not sufficient data to show that products with SPF values higher than 50 provide greater protection for users than products with SPF values of 50.

Consumers Union’s Hansen applauds this proposal:

Our guidance has been that above 30 SPF, there’s not much more protection. We think the 50 SPF limit is a good step. Our concern is that consumers might mistake an SPF of say 100 to provide twice the protection of an SPF 50, when in fact the increased protection is only incremental.

FDA Announces Changes to Better Inform Consumers About Sunscreen [FDA.gov]