New rules for sunscreen in the works

Published: July, 2010

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In 1993, the Food and Drug Administration proposed new regulations for sunscreens. Significant delays have occurred as the FDA wrestled with changing science, the finer points of testing and labeling requirements, and a flood of public comments. New rules were finally scheduled to go into effect in May 2010, but the FDA postponed the target date to October 2010.

Here are a few of the proposed changes:

Companies would test and rank UVA protection, not just UVB. The invisible ultraviolet light that affects the skin is divided into two categories, ultraviolet A (UVA) and ultraviolet B (UVB). UVB is the main cause of sunburn and the more carcinogenic of the two, although both contribute to skin cancer. UVA, which moves at a longer wavelength and is more penetrating, is responsible for tanning and contributes to skin aging.

Many sunscreens currently on the market promise "broad spectrum" protection against both UVA and UVB, but the manufacturers can use whatever tests they want to back up that claim.

Under the new rules, sunscreens would be required to undergo two types of assessments of their UVA-blocking power: a test of the sunscreen itself and another one that compares how fast skin tans with and without the product on. There would be no SPF-like rating, instead, sunscreens would be ranked as providing low, medium, high, or highest UVA protection, with corresponding stars (one for low, two for medium, and so on). Sunscreens won't be required to block UVA, but the label would have to say "No UVA protection" if the product didn't.

SPF tops out at 50+. The SPF is a comparison between the time it takes the skin to turn red with and without sunscreen. The number is calculated like this: if a person normally experiences the onset of redness on unprotected skin after 10 minutes of exposure, an SPF-15 sunscreen would provide protection for 150 minutes. Several years ago the FDA said the data it had received supported SPFs up to 50, so it proposed a cap of 50+. That cap may go up in the final rules. Originally the agency was going to draw the line at 30+.

Sun protection factor gets a new name. The term "sun protection factor" is misleading because it's a measure only of sunburn and UVB protection, not protection against the entire UV spectrum. The proposed rules acknowledge the misnomer and would change the name to sunburn protection factor.

UVA and UVB get equal billing. The FDA is proposing to require that the sunscreen label have a statement that mentions the importance of both UVA and UVB protection. In addition to the SPF number, UVB protection will be described as low, medium, high, and highest, so it matches the new UVA rating system. The agency is also proposing that the information about UVA and UVB be printed in the same font and type size.

Generous and liberal use still encouraged. Most people use less than half the amount of the sunscreen required to get the SPF protection on the label. So far, the FDA has rejected suggestions that would change SPF testing so it would reflect more realistic amounts of sunscreen. Another suggestion was to have the label on the bottle spell out quantities per application. But under the rules as proposed, the label would continue to say that sunscreen should be applied "liberally" or "generously" before sun exposure.

Reapplication emphasized. Even a fairly weak sunscreen can provide protection in intense sunlight if it's reapplied often. The new rules would tighten up the reapplication language. The label on many sunscreens would suggest reapplying sunscreen at least every two hours and after swimming, sweating, or drying off with a towel.

Consumers get a new warning. The FDA wants to get rid of an optional "sun alert" and replace it with a mandatory one that will be labeled as a warning. This is the proposed wording: "UV exposure from the sun increases the risk of skin cancer, premature aging, and other skin damage. It is important to decrease UV exposure by limiting time in the sun, wearing protective clothing, and using a sunscreen."

No skin aging or skin cancer claims allowed. Despite the new warning, sunscreen makers would not be allowed to claim their products reduce skin aging or prevent skin cancer. As of this writing, the FDA had taken the position that such claims would be misleading because of the lack of data showing that sunscreen alone prevents skin aging or cancer. The agency has also said prevention of sunburn or certain kinds of cellular damage can't be extrapolated to prevention of skin cancer.

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