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FDA’s final rule regulates over-the-counter sun protection products, labels and drug claims

September 21st, 2012 | Posted in: Skincare | Tags: , ,

FDA’s final rule regulates over-the-counter sun protection products, labels and drug claims

The FDA’s final rule regulates over-the-counter sun protection products, labels and drug claims. Under the new rule, all labels claiming broad spectrum protection:

–          Must have an SPF of 15 or higher and pass specific FDA testing

–          Are allowed to state that they can reduce the risk of skin cancer and early signs of aging with an SPF of 15 or higher

–          May only claim to help prevent sunburn for SPFs lower than 15

–          Cannot exceed an SPF of 50+, as no data has demonstrated that SPFs higher than 50 are more effective

–          With proper testing can claim “water-resistant” and must state effectiveness – either 40 or 80 minutes while swimming or sweating

–          Can no longer be identified as “sunblocks”

–          Can no longer claim to protect immediately upon application, nor protect for more than two hours without reapplying

–          Must have a clear and accurate “Drug Facts” listing on the container

–          Must clearly state “broad spectrum” on the product itself

Now, you are better informed!