FDA’s New Sunscreen Labels: Just in Time for Summer

In December 2012, the FDA finalized testing and labeling requirements for over-the-counter sunscreen products with sales of $25,000 or more.  Although summer doesn’t officially begin until June 21st, Memorial Day weekend will kick off the summer season for much of the country.  Before you head to the pool or the beach, here are a few things you should note. 

Sunscreen Basics

Sunlight exposes the skin to both ultraviolet A (UVA) and ultraviolet B (UVB) rays.  UVB rays are the main cause of sunburn, but UVA rays contribute, as well.  UVA rays also contribute to premature aging and wrinkling.  All forms of sunscreen block UVB rays, but not all block UVA rays.

The SPF is a measure of the length of time it takes the skin to turn red after applying sunscreen.  For example, a sunscreen with an SPF of 15 will prevent your skin from turning red 15 times longer than it would without sunscreen.  However, the formula doesn’t seem to hold true as SPF levels increase.  SPF 15 filters out about 93 percent of UVB rays, SPF 30 filters out 97 percent, and SPF 50 filters out 98 percent.

Each day, the National Weather Service calculates the UV index for all areas of the country, which is then posted on the Environmental Protection Agency’s (EPA’s) website to provide information about the dangers of UV rays on a given day.  The website rates the index on a scale including values of low, moderate, high, very high, and extreme.  The EPA also provides the following rule of thumb:  if your shadow is taller than you are in the early morning and late afternoon, UV exposure is likely to be low; if your shadow is shorter than you around midday, UV exposure is likely to be high.

FDA Labeling Requirements

The FDA will now allow products that include protection from both UVA and UVB rays to be labelled as “broad spectrum” Sunscreens that are not broad spectrum or do not offer an SPF of at least 15 must be labelled with the following warning:  “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.”  The FDA recommends utilizing broad spectrum sunscreens with a sun protection factor (SPF) of at least 15.   The American Academy of Dermatology, however, recommends using a broad spectrum, water-resistant sunscreen with an SPF of at least 30. 

The FDA requirements also ban the use of familiar terms.  “Sunblock” is no longer permitted, since no product exists that completely blocks harmful rays.  Similarly, “waterproof” and “sweatproof” are banned because no product offers such complete protection.  Instead, labels may suggest that sunscreens are water or sweat “resistant.”  Products that claim to be resistant must indicate on the label whether they protect for 40 or 80 minutes while swimming or sweating.  If not swimming or sweating, consumers should reapply sunscreen every two hours.  The FDA also recommends avoiding the sun from 10 A.M. to 2 P.M., although many experts recommend avoiding it between 10 A.M. and 4:00 P.M. 

Future Labelling Changes?

Because the FDA does not have any data indicating that sunscreen products with SPFs greater than 50 provide additional benefits, it is considering requiring sunscreens with SPFs greater than 50 to simply be labelled “50+.”  It has also requested data from sunscreen spray product manufacturers to determine their effectiveness and whether they present a safety concern if accidentally inhaled.