While many consumers purchased sunscreen in confusion over the bottles' sun protection numbers and early aging or cancer prevention claims, the FDA worked to clarify its rules. The agency's new and improved sunscreen regulations take effect next summer.
The U.S. Food and Drug Administration has been aiming to upgrade its sunscreen labeling rules for decades, according to FDA consumer information last updated August 2007 and other information published on the agency's website. This week the FDA revealed the new labeling standards sunscreen manufacturers must use to inform consumers about their products' abilities to protect against harmful sun rays and prevent skin cancer and premature skin aging.
According to the FDA announcement:
Most companies will have a year to implement the changes. Smaller manufacturers with annual sales less than $25,000 have an extra year to comply.
Unlike the standards in effect now that apply only to ultraviolet B (UVB) sunburn-causing rays, the new rules require sunscreen also to protect against ultraviolet A (UVA) rays that cause more molecular-level damage to skin cells, possibly leading to skin cancer and accelerated skin aging, because more UVA rays make it through the atmosphere and they penetrate skin more deeply.
Products labeled "broad spectrum" (meaning they cover the UVA and UVB ranges of the ultraviolet spectrum) that have a sun protection factor (SPF) of 15 and above can effectively block both types of dangerous ultraviolet rays and carry the claim "[This product,] 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."
A warning label stating, "This product has been shown only to help prevent sunburn, not skin cancer or early skin aging," will be required on broad spectrum and other sunscreens that have SPFs lower than 15.
According to an Associated Press report:
The "sweatproof" and "waterproof" labels that often appear now on many sunscreens will no longer be permited, because the FDA considers the terms "exaggerations of performance."
The FDA wants to cap the SPF value listed on sunscreen labels to 50, unless manufacturers can prove, through additional scientific testing, that products merit a higher rating.
The four-star system used now by some companies to rate UVA protection must be phased out.
Some consumer advocates are complaining that draft proposals were stronger than these new guidelines.
According to the National Cancer Institute:
Melanoma, an often lethal form of skin cancer that begins in the pigment-producing cells called melanocytes, caused 8, 700 deaths in 2010, while 68,130 new cases were reported.