FDA Orders Sunscreen Makers to Change Claims on Labels

ALTudor Editor
  • The U.S. Food and Drug Administration (FDA) has ordered sunscreen makers to alter the wording and claims on its products, saying that some of the labels contain information that is misleading or incorrect.


    For example, the words “sunblock,” “waterproof,” and “sweatproof” must be removed from sunscreen labels, since no sunscreen can completely block harmful radiation and all wear off eventually.  Labels will also have to specify which sunscreens only prevent sunburn and which – when combined with other sun protection measures – can help prevent skin cancer. 


    The difference?  The sunscreen’s sun protection factor, or SPF, and its ability to block sun radiation. With the new labels, only those products with a SPF rating of 15 or greater and that have passed a so-called “Broad Spectrum” test to show they block both UVA and UVB rays will be able to claim that they help prevent skin cancer.  Also, those sunscreen products that have not passed these tests or carry these SPF ratings will be required to carry labels that say they do not prevent skin cancer or early skin aging.

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    As for those products that are labeled with SPF ratings of “50+,” the FDA’s sunscreen task force also issued a “Proposed Rule” stating that labels should not be able to carry this SPF designation, since there is little evidence that SPF ratings of more than 50 provide greater skin cancer protection.  (The FDA did invite evidence to prove these claims, however.)


    The FDA originally asked for the labeling changes to be made by this summer in an effort to better inform and protect consumers. But on May 10th, the regulatory agency issued a six-month extension after many manufacturers reported that making the labeling changes that quickly would likely lead to a shortage of sunscreen products this summer. Smaller companies will receive an even longer extension for their label changes, until December 2013.


    So what does this mean for you?  Well, these changes will likely better inform consumers about what their sunscreens can – and cannot – do. But beyond that, the actual makeup of most of the sunscreen products themselves are not likely to change. That’s because most sunscreens can already pass the FDA’s Broad Spectrum tests as they are.


    But the label changes are a wake-up call for consumers in another way.  Skin cancer experts say that sunscreen is only a small part of protecting yourself from sun-related skin damage and cancer. Covering up and reducing sun exposure time are still the best ways to prevent sun-related skin damage. The label changes should simply act as a reminder that relying too heavily on sunscreen without changing your sun habits isn’t going to offer you all of the protection your skin needs.




    Sources:  U.S. Food and Drug Administration; USA Today

Published On: May 11, 2012