FDA Unveils New Sunscreen Regulations

On June 14, the U.S. Food and Drug Administration published new guidelines that "establish a standard test for over-the-counter sunscreen products that will determine which products are allowed to be labeled as 'Broad Spectrum.'” 

According to the FDA's consumer update report, sunscreens that pass this test will protect against both ultraviolet B radiation [UVB] and ultraviolet A radiation [UVA]. The report states that sunburn is caused primarily by UVB, but both UVB and UVA can cause sunburn, skin cancer and premature skin aging.

"A certain percentage of a broad spectrum product’s total protection is against UVA," as stated in the report.

Under the FDA's new regulations, the sunscreen products that protect against skin damage caused by the sun will be labeled "Broadspectrum" and have the sun protection factor [SPF]  on the front of the bottle. In addition, the guidelines specify that the back labels on bottles of sunscreen that are both "Broadspectrum" and with an SPF of 15 or higher that they "not only protect against sunburn, but, if used as directed with other sun protection measures, can reduce the risk of skin cancer and early skin aging."

The FDA's final regulations for sunscreens are meant to help consumers choose and use them appropriately:

• Sunscreen products that are not broad spectrum or that are broad spectrum with SPF values from 2 to14 will be labeled with a warning that reads: “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.” 
• Water resistance claims on the product's front label must tell how much time a user can expect to get the declared SPF level of protection while swimming or sweating, based on standard testing. Two times will be permitted on labels: 40 minutes or 80 minutes.
• Manufacturers cannot make claims that sunscreens are “waterproof” or “sweatproof, or identify their products as “sunblocks.”   Also, sunscreens cannot claim protection immediately on application or protection for more than two hours without reapplication, unless they submit data and get approval from FDA

According to the report, the FDA does not currently have "adequate data" that shows that sunscreens with SPF values higher than 50 provide additional protection compared to sunscreens with a SPF value of 50. Therefore, the FDA is proposing a regulation that would require sunscreens that have SPF values higher than 50 to be labeled as “SPF 50+.”

In addition to its new regulations for sunscreen, the FDA's report provides sun safety tips:

• Use sunscreens with broad spectrum SPF values of 15 or higher regularly and as directed.
• Limit time in the sun, especially between the hours of 10 a.m. and 2 p.m., when the sun’s rays are most intense.
• Wear clothing to cover skin exposed to the sun; for example, long-sleeved shirts, pants, sunglasses, and .
• Reapply sunscreen at least every 2 hours, more often if you’re sweating or jumping in and out of the water.