Sunscreens: Safe Sunning

by Food and Drug Administration (FDA)

(Page 3 of 4)

In the final monograph completed last year, FDA proposed limiting SPF values on a sunscreen label to 30. Products with higher SPFs would be labeled "30+" (or "30 plus"). The agency took this action for two reasons: inadequacies in the testing methodologies for higher-level SPF formulations, and concern that the high SPF labeling may lead consumers to spend more time in the sun than they should.

The SPF portion of FDA's monograph immediately produced opposition from both industry groups and consumer organizations. The National Coalition for Sun Safety, an organization supported by the American Academy of Dermatology, advocated "a floor rather than a cap on SPF," wrote coalition co-chairmen Rex Arnonette, M.D., and Roger Ceilley, M.D. The organization wants a minimum level of SPF to ensure that all products provide some protection.

Industry, primarily represented by the Cosmetic, Toiletry and Fragrance Association (CTFA), opposed the 30-plus cap for several reasons, including consumer confusion, fear that manufacturers would remove effective sunscreen protection in their products to avoid misbranding, and unresolved scientific issues about UVA. With the deferral of the monograph's implementation, the industry, along with the agency, will have additional time to resolve the issues.

The Labeling Controversy

The questions surrounding labeling, which may have less to do with science and more to do with motivating human behavior, may prove to be the thorniest of all. Everyone agrees on the goal: Create a simple label that consumers can easily understand.

In addition to recommending the SPF limit on labels, FDA has proposed further label changes to help clarify the risks and benefits of sunscreen use and how to use the products properly. For example, FDA wants the label to avoid unsupported, misleading or confusing terms such as "sunblock," "waterproof," "all-day protection" and "visible and/or infrared light protection." And when the label says the product is "water resistant," or "very water resistant," it must mean that the product provides the stated SPF level after water resistance testing for a specified length of time. FDA and the industry also are wrestling with what it means to claim that a sunscreen is "broad-spectrum," that is, protective against both UVA and UVB.

Complexity is the problem because consumers want simplicity. Industry already has conducted studies that test the effectiveness of different ways to present information on the label. For example, Schering-Plough Health Care Products of Berkeley Heights, N.J., tested a label that contained another number in addition to the SPF to indicate the degree to which the product protected against UVA. "The second protection number created unnecessary complications and confusion for the consumer," says Patricia Agin, Ph.D., Schering-Plough's photobiology research director. "UVA should complement and not distract from SPF on the label. A descriptive approach better conveyed to consumers the added benefit of UVA protection and did not distract from the SPF number."

"SPF should remain the primary index of efficacy," agrees Jay Nash, Ph.D., of Proctor & Gamble Pharmaceuticals Inc., of Mason, Ohio, "and any additional descriptor should be independent and commensurate with this information. Simplicity is the key to public policy."

Simple or not, the labeling issue is not trivial because studies already show that consumers may not use sunscreens correctly. The public under-applies sunscreens by as much as half of the recommended amount, concluded a study published in the Archives of Dermatology. Consequently, the study argued, consumers are receiving only half of the SPF protection they believe the product provides.

Couple that with prolonged periods of baking in the sun and you have a recipe for future disease.

Safe Sunning

The basic advice about protecting yourself from the harmful effects of the sun remains sound, according to the Department of Health and Human Services. The department continues efforts, launched in 1998 with its "Choose Your Cover" public education campaign, to help all Americans, but especially the young, prevent skin disorders associated with excessive exposure to the sun.

The recommendation is simple: To prevent premature aging, sun damage, and skin cancer, you need to protect yourself and your family from the harmful ultraviolet (UV) rays of the sun. And sunscreen alone will not protect you. You need to use a total program to reduce the sun's harmful effects, including:

Lavishly apply a sunscreen with a sun protection factor (SPF) of at least 15 and reapply it every two hours according to the directions on the label.

Reapply sunscreen as needed after swimming, sweating or towel drying. And use sunscreen even on cloudy days.

Avoid the sun during the middle of the day, especially between 10 a.m. and 4 p.m., when the atmosphere absorbs less of the harmful UV rays of sunlight than earlier or later in the day.

If you have to be out in the midday sun, avoid long periods of direct sun exposure. Stay in the shade.

Wear a wide-brimmed hat, protective clothing, and sunglasses.

Never leave children exposed to the sun without adequate protection. Because of the long time it takes for cancer to develop, studies suggest that over-exposure early in life may lead to skin cancers later in life.

Although industry studies show that consumer use of sunscreen products continues to improve — up 13 percent in 1999 — the American Academy of Dermatology (AAD) says that consumers still do not apply the correct amounts of sunscreen to achieve the full benefit.

A study sponsored by Seventeen Magazine, Beiersdorf Inc.'s Nivea brand, and the AAD found an increase in the use of sunscreen by teens, but also found problems: Eighty-eight percent of teens spend a significant amount of time in the sun, but only 72 percent say they use sunscreen at least some of the time. Only about 40 percent of the teens say they use sunscreen often or all of the time. Young women use sunscreen more than young men (46.2 percent compared to 30.5 percent), and the reasons given for not using it include the belief that they never burn (30 percent), inconvenience (17 percent), and the desire for a dark tan (6 percent).

The difficulty, of course, is that teenagers won't see the effects of sun damage until they reach their 40s and 50s or later. By then, however, the damage already is done.

About the Author

www.fda.gov
FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.