Tuesday, June 28, 2011

FDA issues new rules for sunscreen labels

The Food and Drug Administration is issuing new rules about the labeling of sunscreens. The new rules are designed to make it easier for consumers to know what they’re buying and if desired, select sunscreens that are most effective in preventing skin cancer and early aging.

The new rules, which will take effect the summer of 2012 (although some manufacturers will implement them sooner) will only allow sunscreen products that pass the FDA’s test for protection against both ultraviolet A (UVA) and ultraviolet B (UVB) rays to be labeled as “Broad Spectrum.” Both UVB and UVA radiation contribute to sunburn, skin cancer, and premature skin aging. Sunburn is primarily caused by UVB radiation.

Products that have SPF values between 2 and 14 may be labeled as Broad Spectrum if they pass the required test, but only products that are labeled both as Broad Spectrum with SPF values of 15 or higher may state that they reduce the risk of skin cancer and early skin aging, when used as directed. Any product that is not Broad Spectrum, or that is Broad Spectrum but has an SPF between 2 to 14, will be required to have a warning stating that the product has not been shown to help prevent skin cancer or early skin aging.

“Not only should consumers regularly apply and reapply sunscreens with Broad Spectrum and SPF of 15 or higher, they should also limit sun exposure,” says Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research.

The new rule will also prohibit sunscreen manufacturers from using the terms “waterproof” or “sweat proof” because the FDA felt the terms overstated what sunscreens can actually do. Instead, terms such as “water resistant” will be used. If this term is used, the label must indicate whether the protection should last 40 or 80 minutes. Sunscreen labels also will not be allowed to promise more than two hours of protection without first submitting evidence to the FDA and gaining their approval for additional claims.

The rules will also apply to any cosmetics or moisturizers that say they provide SPF protection.

For more details, please visit the FDA’s Website at: http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/UnderstandingOver-the-CounterMedicines/ucm258468.htm#Q6_What_are_the_main_points

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