With Advent of Summer, New Sunscreen Rules From FDA

by Renée Canada

It’s once again that time when schools are letting out for the calendar year. People are packing up for vacations, and more of us will be taking advantage of the rising temperatures to spend time outdoors. Tuesday, June 21, not only marked the beginning of summer, but also the longest day of daylight.

With extra daylight come more opportunities for people to be exposed to the sun. Appropriately, the U.S. Food and Drug Administration recently took steps to clarify which sunscreen lotions were the most effective protection against the potential damaging effects of the sun.

Prior rules on sunscreens primarily addressed protection against ultraviolet B (UVB) radiation from the sun, failing to tackle damage caused by ultraviolet A (UVA) rays. Now, the FDA has established a “standard broad spectrum test” that measures a product’s UVA protection relative to its UVB protection. Sunscreen products that pass this test, protecting against both UVA and UVB rays, may be labeled as “Broad Spectrum.”

For newly labeled “broad spectrum” sunscreen products, the Sun Protection Factor, or SPF, also indicates the overall amount of protection provided. Only those products with an SPF of 15 or higher can claim to help “reduce the risks of sunburn, skin cancer and early skin aging, when used as directed with other sun protection measures,” said FDA Dermatologist Jill Lindstrom, M.D.

“Sunscreen less than SPF 15 is unhelpful in terms of skin cancer protection so I am glad this has been defined for the public,” said David J. Leffell, M.D., professor of dermatology and surgery at Yale University School of Medicine.

The American Academy of Dermatology recommends products with an SPF of at least 30. Sunscreens with SPF values under 15, whether they are labeled Broad Spectrum or not, can only claim to help protect against sunburn.

“There is no evidence that SPF values greater than 50 provide any additional benefit,” said Lindstrum.

Companies that used to label their sunscreen products as waterproof or sweat-proof must now eliminate these terms. According to the FDA, these manufacturers “overstate their effectiveness.” Sunscreens claiming water resistance must indicate the length of their effectiveness, such as for 40 or 80 minutes, while swimming or sweating. If a sunscreen product is not water resistant, it must include instructions for consumers to use water-resistant sunscreen when swimming or sweating.

People should reapply sunscreen “every two hours and more often if you’re sweating or jumping in and out of the water,” said Lindstrom.

All sunscreens must include standard “Drug Facts” information on the back or side of the container. Leffell states that this is probably the most helpful addition to the new sunscreen regulations. “[Sunscreens] have significant beneficial effects and this new requirement will help consumers better understand what ingredients do,” he said.

One form of sunscreen left out of the mix is sun spray. According to the FDA, data and information on spray is “not comparable to that for sunscreens in other dosage forms,” and the way they are applied is significantly different.

The FDA first proposed changing sunscreen labels in 1978. While acknowledging that the guidelines have been a long time in coming, Leffell said they represent an intelligent middle ground. “They will clarify the issues for the consumer and address the technical needs of the industry, which are not insignificant,” he said.

These latest changes are set to go in effect by the summer of 2012.

“The public will benefit from clearer labels and now understand better the idea and need for UVA protection,” Leffell said.

The American Cancer Society states that UVA rays contribute to early skin aging such as wrinkles, while UVB rays are the main cause of sunburns. While UVA rays play a role in some skin cancers, UVB rays are thought to cause most skin cancers.

An estimated $2 billion is spent treating skin cancer annually according to the National Council for Skin Cancer Prevention (NCSCP). More people were diagnosed with skin cancer in 2009 than with breast, prostate, lung, and colon cancer combined.

Young people are not immune to the disease. Leffell has seen cases of women in their 20s, “which used to be unheard of,” he said.

So if you’re going to be spending significant time out in the sun, slather on the sunscreen and slip on your sunglasses and a hat. Cover up as much as you can—tightly woven, darker colored clothing is the best protection against UV rays.


Here are more sunscreen tips from Leffell:

• Use a sunscreen with an SPF of 30 that also provides broad spectrum (ingredients to look for: avobenzone or zinc oxide)

• Apply every couple of hours while active outdoors (claims of sweat-proof and waterproof will no longer be accepted by the FDA)

• Make sure that you avoid the sun during peak hours of 10 am to 4 pm.

You can check the UV index for the day here.


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