The FDA announced yesterday that effective next year the labels of sunscreen products will contain new information to better inform consumers of sunscreen products’ levels of protection and ability to reduce the risk of skin cancer, early skin aging and sunburn.

Sunscreen products approved by the FDA for protection against both UVA and UVB rays can now be labeled as “Broad Spectrum.” Under the new labeling, says the FDA, “sunscreens labeled as both Broad Spectrum and SPF 15 (or higher), if used regularly, as directed, and in combination with other sun protection measures will help prevent sunburn, reduce the risk of skin cancer, and reduce the risk of early skin aging.”

Products that have an SPF between two and 14 may be labeled as “Broad Spectrum” if they pass FDA testing, but only sunscreens that are SPF 15 or higher can state on their labels that they reduce the risk of skin cancer and early skin aging when used as directed. Sunscreens that are not “Broad Spectrum” or that are “Broad Spectrum” but have an SPF between two and 14 will now be required to display warning labels that read the following: “Skin Cancer/Skin Aging Alert:  Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.”

Additionally, manufacturers can no longer claim that sunscreens are “waterproof” or “sweatproof,” nor can they identify their products as “sunblock.” Manufacturers that claim their products are “water resistant” must include on the front label that consumers can expect the stated level of SPF while swimming or sweating for either 40 or 80 minutes. Claims of “instant” or “immediate” protection or claims of protection for more than two hours without reapplication will no longer be permitted unless approved by the FDA.

Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research, said in a statement, “The 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.”

Woodcock says that for the best sun protection, consumers should regularly wear “Broad Spectrum” sunscreen with an SPF 15 or higher and be sure to reapply. Consumers are also encouraged by the FDA to limit sun exposure especially between 10 a.m. and 2 p.m., to wear clothing to cover exposed skin in the sun and to reapply sunscreen at least every two hours.

The FDA released three additional regulatory documents, one of which, a Proposed Rule, would limit the maximum SPF on sunscreen labels to be “50+,” as there are insufficient data demonstrating that SPF values above 50 provide an increase in protection. An Advance Notice of Proposed Rulemaking for Dosage Forms will address the effectiveness and safety of sunscreen sprays and address sunscreen dosages. The third document, the Draft Enforcement Guidance for Industry, will aid manufacturers in understanding how to label and test their products.

The FDA is also reexamining the safety of sunscreens’ active ingredients.

About The Author

Shannon O'Neill is a senior editor at Bombshell.

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