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Starting in June 2012, new sunscreen guidelines from the FDA (Food and Drug Administration) will be required. Manufacturers must meet new labeling rules that address five main areas.
1. Broad Spectrum designation: Now, manufacturers must indicate how well the product protects against both UVA rays and UVB rays by using the term “Broad Spectrum SPF”.
In the past, sunscreens only had an SPF rating, which just addressed UVB rays. Containers stated “SPF 15” or above. The Broad Spectrum designation indicates protection against both UVA and UVB rays.
Additionally, no products can show a Broad Spectrum SPF above 50. The FDA feels “there is not sufficient data to show that products with SPF values higher than 50 provide greater protection for users than products with SPF values of 50”.
2. Use claim: Only products that show a Broad Spectrum protection of SPF 15 or above can claim to reduce cancer if used as directed. “Non-Broad Spectrum sunscreens and Broad Spectrum sunscreens with an SPF value between 2 and 14 can only claim to help prevent sunburn”.
3. Water Resistance claims: Sunscreen must include how many minutes it remains effective when wet. For example, labeling might say “Water Resistant: 40 min”
4. Marketing Terms Limitations: Sunscreens can no longer state claims of “all day protection”, sweat proof, waterproof, instant protection or sunblock , which overstate the effectiveness of their products. They cannot claim that protection lasts longer than two hours without reapplication.
5. Drug Facts: All sunscreens must now list drug information on the back or side of the container like all other over-the-counter products.
Cosmetics that advertise sunscreen protection must also abide by the FDA labeling guidelines.
The new labels will look like this.
The FDA has worked for the last 30 years to develop these improved standards for sunscreen labeling protection. The reason they feel this is important is that both UVA and UVB rays contribute to risk of skin cancer.
UVA radiation is made up of long-wave rays that penetrate deeper into the skin while UVB rays are shortwave rays that cause sunburn and other minor skin damage.
The rules to not apply sunscreen to babies under 6 months will continue because their skin is much thinner, so they absorb more sunscreen. The recommendation for babies is to use clothes and other methods to shield them from the sun.
Some people have expressed concerns that sunscreens are “poisonous” and that the FDA should address those concerns. Henry Lim, M.D., chair of dermatology at Detroit’s Henry Ford Hospital and chair of the science and research council of the American Academy of Dermatology (AAD) stated, “The risk of not applying sunscreen is greater than any the risk of any toxic chemical being in sunscreen.”
Dr. Lim addressed what is known about three of the main components in sunscreen. He stated that studies have not confirmed claims that: (1) retinyl palmitate, a vitamin A derivative, causes cancer, that (2) oxybenzones cause hormonal side effects, nor that (3) nanoparticles in sunscreen have been found to pass through the skin into the bloodstream.
Other precautions like wearing clothes and hats for additional skin protection, and staying out of the sun during the peak times of the day between 10 a.m. – 2 p.m., should still be practiced in addition to sunscreen use.
The FDA recommends people use broad-spectrum, water-resistant sunscreens with an SPF of 15 or higher. However, the AAD (American Association of Dermatology) recommends broad-spectrum, water-resistant sunscreens with an SPF of at least 30.
Sources:
Questions and Answers: FDA announces new requirements for over-the-counter (OTC) sunscreen products marketed in the U.S. FDA: U.S. Food and Drug Administration. Retrieved May 12, 2012. http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSa...
FDA Announces New Sunscreen Rules-'Broad Spectrum' Means UVA Plus UVB Protection. WebMD. Retrieved May 12, 2012.
http://www.webmd.com/healthy-beauty/news/20110614/new-sunscreen-rules-fr...
FDA’s New Sunscreen Rules: FAQ. WebMD blogs. Retrieved May 12, 2012. http://blogs.webmd.com/breaking-news/2011/06/fdas-new-sunscreen-rules-fa...
Michele is an R.N. freelance writer with a special interest in woman’s healthcare and quality of care issues. Other articles by Michele are at www.helium.com/users/487540/show_articles
Edited by Jody Smith
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