Hot Summer Weather Brings New Label Requirements For Sunscreen -- FDA Announcement

Hot summer weather and sunburns go hand in hand. Just in time for the summer tanning season, the FDA has announced new requirements for sunscreen currently sold over-the-counter (OTC), i.e. non-prescription. The requirements take effect by the summer of 2012, but consumers may begin to see changes to sunscreen labels before the effective date. Here's the scoop from the Q & A:

Sunburn is primarily caused by UVB. 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.
Under the new regulations, sunscreen products that protect against all types of sun-induced skin damage will be labeled "Broad Spectrum" and "SPF 15" (or higher) on the front.

The new labeling will also tell consumers on the back of the product that sunscreens labeled as both "Broad Spectrum" and "SPF 15" (or higher) 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. For these broad spectrum products, higher SPF (Sun Protection Factor) values also indicate higher levels of overall protection.

By contrast, any sunscreen not labeled as "Broad Spectrum" or that has an SPF value between 2 and 14, has only been shown to help prevent sunburn.

To help consumers select and use sunscreens appropriately, the final regulations include these additional labeling provisions:

*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 (for example, "instant protection") or protection for more than two hours without reapplication, unless they submit data and get approval from FDA.

CBS News reports that the Environmental Working Group claims the FDA standard is too weak for protection against UVA rays, blurring the line for consumers between effective sunscreens and mediocre ones. The group also criticized the FDA for continuing to allow potentially dangerous sunscreen ingredients to be used despite health concerns.

June 16, 2011

Hot Summer Weather Brings New Label Requirements For Sunscreen -- FDA Announcement