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Sunscreens, Tanning Products, and Sun Safety

syndicated from the FDA

Skin damage from sunlight builds up with continued exposure, whether sunburn occurs or not. In addition to skin cancer and sunburn, effects related to premature aging can include wrinkling, and in time, an almost leathery appearance of the skin. Research also suggests that excessive exposure to UV radiation may interfere with the body’s immune system.

Sunburn is associated with the shorter ultraviolet wavelengths, known as ultraviolet B (UVB). The longer wavelengths, known as ultraviolet A (UVA), however, can penetrate the skin and damage connective tissue at deeper levels, even if the skin’s surface feels cool. It is important to limit exposure to both UVA and UVB.

The following information on sunscreens, tanning products, and sun safety is intended to help consumers make informed decisions about sun protection and tanning.

Sunscreens

Sunscreens play an important role as one part of a total program to reduce the harmful effects of the sun, that first includes limiting sun exposure and wearing protective clothing. FDA regulates sunscreens as over-the-counter (OTC) drugs (see Title 21 of the Code of Federal Regulations (CFR), Part 352, Sunscreen Drug Products for Over-the-Counter Human Use). Cosmetic products that are marketed with sun-protection claims are regulated as both drugs and cosmetics.

To help consumers select products that best suit their needs, sunscreens are labeled with SPF numbers. SPF stands for “Sun Protection Factor.” The higher the SPF number, the more sunburn protection the product provides. Experts recommend using sunscreens with an SPF number of 15 or higher that also provide protection from UVA rays. Remember, sunscreen use alone will not prevent all of the possible harmful effects of the sun.

The effectiveness of a sunscreen is reduced if it is not applied in adequate amounts or it is washed off, rubbed off, sweated off, or otherwise removed. For maximum effectiveness, apply a sunscreen liberally before going outside and reapply it frequently on all sun-exposed skin. Unless otherwise stated on the label, 30 minutes before going outside and at least every two hours thereafter is a general rule of thumb. About one ounce of sunscreen should be used per application on the average adult.

Label Warning Requirement for Suntanning Products Without Sunscreen

FDA is concerned about the health hazards associated with suntanning products that do not contain sunscreen ingredients. Such suntanning products must bear the following warning statement:

More Sunscreen Regulations Are Coming

The monograph for OTC sunscreen drug products (21 CFR 352), published on May 21, 1999, addresses the testing and labeling of sunscreen products for the prevention of sunburn (that is, UVB radiation protection). The effective date for manufacturers to comply with the requirements of the monograph was subsequently delayed until December 31, 2002.

FDA intends to publish a proposal to amend the sunscreen monograph in order to develop a comprehensive monograph that addresses formulation, labeling, and testing requirements for both UVB and UVA radiation protection. Following that publication, there will be a public comment period and then FDA will prepare an amended final monograph for publication in a future issue of the Federal Register. Because FDA had not yet published the proposed amendment to the monograph, it was not possible for manufacturers of OTC sunscreen drug products to relabel and test their products by the December 21, 2002 effective date. Therefore, on December 31, 2001, FDA delayed the effective date of the sunscreen monograph until further notice is provided in the proposed amendment. FDA anticipates that this new effective date will not occur before January 1, 2005.

Tanning Accelerators

Lotions and pills marketed as “tanning accelerators” often contain tyrosine (an amino acid), often in combination with other substances. Tanning accelerators may be marketed with the claim that they enhance tanning by stimulating and increasing melanin formation. FDA has concluded that these “tanning accelerators” are actually unapproved drugs, and the agency has issued warning letters to several manufacturers of these products. There is a lack of scientific data showing that they work; in fact, at least one study has found them ineffective.

Tanning Pills

Pills that contain large doses of canthaxanthin are sometimes marketed as “tanning pills.” Although FDA has approved canthaxanthin for use as a color additive in foods, where it is used in small amounts, its use as a tanning agent is not approved. Imported tanning pills containing canthaxanthin are subject to import detention as products containing non-permitted color additives.

When a person ingests canthaxanthin in large quantities, the substance is deposited in various parts of the body, including the skin, where it imparts a color ranging from orange to brownish. Tanning pills have been associated with side effects, particularly a condition called “canthaxanthin retinopathy,” the formation of yellow deposits in the retina of the eye.

Sunless Tanners and Bronzers

Sunless tanners, sometimes referred to as self-tanners or tanning extenders, are promoted as a way to get tan without the sun. They produce a tanned appearance by interacting with amino acids on the skin’s surface. The only color additive currently approved by FDA for this purpose is dihydroxyacetone (DHA). These products can be difficult to apply and the chemicals may react differently on various areas of your body, resulting in uneven coloring.

The term “bronzer” refers to a variety of products used to achieve a temporary tanned appearance. Some are applied topically to stain the skin temporarily. Usually, soap and water will remove them. They may streak after application and, when wet, some may stain clothing.

Among other products marketed as bronzers are tinted moisturizers and brush-on powders. These also produce a temporary effect, similar to other types of makeup. Still others are combination products that also contain DHA.

Sunless tanners and bronzers may or may not contain sunscreen ingredients or be labeled with SPF numbers. Consumers are advised to read the labeling carefully to determine whether or not these products provide protection from the sun.

More Sun-Safety Tips

When at the beach or pool, cover exposed areas with tightly woven clothing and wear a wide-brimmed hat to protect your head and face. If you’re a parent, protect your children’s skin; research indicates that one or more severe, blistering sunburns in childhood or adolescence can double the risk of skin cancer later in life.

Remember that the sun’s rays are the strongest from 10:00 a.m. to 4:00 p.m, especially during the late spring and summer. Reflected glare from water and snow also can increase your exposure to UV radiation.

It is equally important to protect your eyes from the sun. Too much UV radiation can damage the cornea and lead to cataracts, a clouding of the lens of the eye that can cause blindness. Not all tinted glasses – even very dark ones – protect against UV radiation. The UV filtration results from an invisible chemical applied to the sunglasses. Check the label when choosing sunglasses in order to make sure that they provide protection against UV radiation.