Understanding the New FDA Sunscreen Guidelines

Just when you thought you understood the SPF (sun protection factor) system, the labels are changing. To protect consumers from skin damage and false advertising, the U.S. Food and Drug Administration (FDA) created new regulations in June 2011 that require all sunscreens to be tested for protection against UVA and UVB radiation — the two types of sun exposure that cause sunburn, skin cancer and premature aging — and limit how manufacturers can label their products.

UVA + UVB = "Broad Spectrum"

Under the new rules, effective in June 2012, only sunscreens that protect against both UVA and UVB rays can be labeled “broad spectrum.” While UVB rays are primarily responsible for causing sunburn, both types cause skin cancer and premature aging. Products that protect against all types of sun-induced skin damage will be labeled “broad spectrum” and “SPF 15” or higher on the front of the product. Sunscreens that do not offer broad-spectrum protection or those with SPF values of 2 to 14 must contain a warning label stating that the product “has been shown only to help prevent sunburn, not skin cancer or early skin aging.”

Water Resistant vs. Waterproof / Sweatproof

Because no sunscreen is completely waterproof, the terms “waterproof,” “sweatproof” and “sunblock” are no longer allowed on labels. Products may be labeled “water resistant” only if they pass the FDA’s water-resistance test, which involves applying sunscreen to human subjects and submerging them in a whirlpool or tub of water for either two or four 20-minute periods. Any water-resistance claims must state how much time — 40 minutes or 80 minutes — a person can expect to get the declared SPF while swimming or sweating. The products also must provide directions for reapplying after sweating or swimming.

Children and Infants

Although there are no changes in the FDA guidelines specifically related to children and infants, it is important that parents of infants 6 months and younger limit sun exposure during peak hours, from 12 to 2 p.m., and use shade devices, such as hats and umbrellas. For specific product recommendations, talk to your health care provider. All other age groups will benefit from the use of a broad-spectrum sunscreen with an SPF 15 or higher in conjunction with other sun-protection measures.

For more information about the new guidelines, visit FDA.gov or AAD.org.

Posted on April 16, 2012 and filed under Skin Care.