Update May 2012 - FDA delayed labeling rules
- till Dec 2012 for the big companies
- till Dec 2013 for the small companies
- "The FDA took a major step backwards today and as a result, more consumers will likely get burned this summer," said Sen. Jack Reed, D-R.I., who had long urged the FDA to tighten its regulation of sunscreens.
Under the new rules announced Tuesday, the FDA will:
- Allow only sunscreens that pass a test that shows that they shield skin from both ultraviolet A (UVA) and ultraviolet B (UVB) rays to be labeled "broad spectrum," and only those that also have a sun protection factor (SPF) rating of at least 15 can claim that they protect against sunburn, wrinkles and skin cancer.
- Prohibit sunscreen marketing claims such as "waterproof" and "sweatproof," which the agency said "are exaggerations of performance." Water-resistance claims will be allowed, but companies must explain how much time consumers can expect to get the same benefit while swimming or sweating.
- Cap the highest SPF value at 50, unless companies can provide results of further testing that support a higher number.
- Require that manufacturers phase out a four-star system currently used by some companies to rate UVA protection. In reviewing more than 3,000 comments submitted to the agency, the FDA decided the star system was too confusing. Instead, protection against UVA should be proportional to protection against UVB, which is already measured using SPF.
- Prohibit manufacturers from labeling protective products as sunblocks because there is no evidence that they block all the radiation in sunlight.
- What is SPF? SPF — sun protection factor — is how much time is needed to get a sunburn on protected vs. unprotected skin. An SPF rating of 15, for example, means it would take a person 15 times longer to burn wearing that sunscreen compared with someone using nothing.
- UVA vs. UVB: UVB radiation is the major cause of sunburn, while both UVA and UVB cause early skin aging and skin cancer.
- The cancer concern: More than 2 million Americans are diagnosed with skin cancer each year, making it the leading cause of cancer. While most skin cancers are curable, more than 68,000 Americans are diagnosed each year with melanoma — the most dangerous form — and an estimated 8,700 die.
- What do experts say? Most dermatologists recommend a broad spectrum, water-resistant sunscreen of SPF 30 or higher every two hours while outside. People should use about one ounce to cover their bodies.
Consumers will soon have a way to know how well a sunscreen protects them from skin cancer and wrinkles, not just sunburns.
New labels on sunscreens are due by next summer, the Food and Drug Administration announced Tuesday. And it only took 33 years.
The FDA, which first proposed changing labels in 1978, says labels must state which products give "broad spectrum" protection from both major forms of ultraviolet radiation, or UV. One form, UVA, causes wrinkles, while UVB causes burns. Both can cause skin cancer, the American Cancer Society says. More than 2 million Americans are diagnosed with skin cancer each year.
The current system, which touts the sun protection factor, measures only burn protection.
New labels will allow products to claim "broad spectrum" protection only if they pass specific FDA tests for blocking UVA and UVB rays and if they have an SPF of at least 15, said Janet Woodcock, director of the FDA's Center for Drug Evaluation.
This is the first standard for UVA; there weren't reliable ways to test for UVA protection until a few years ago, said Reynold Tan, an FDA scientist.
Products that don't protect against UVA, or that have an SPF of less than 15, will have to carry a warning that they don't protect against skin cancer, Woodcock said. Sunscreens also must carry a "drug facts" box with more detailed information about sun protection.
Although some sunscreens already claim to offer "broad spectrum" protection, consumers have had no way to know what that meant because there was no formal standard, said Darrell Rigel, former president of the American Society for Dermatologic Surgery. "In the past, the words 'broad spectrum' meant nothing."
The FDA announced its intent to draft sunscreen rules in 1978 and published them in 1999. The agency then delayed finalizing the regulations until it could address concerns from both industry and consumers.
The FDA is still working on updated guidelines for spray-on products, which use different formulations from other sun-protection solutions.
Many companies already have adopted some of the language. For example, all Coppertone products from Merck & Co.'s Schering-Plough unit and Neutrogena Sunblock from Johnson & Johnson boast "broad spectrum UVA and UVB protection."
The U.S. market for sunscreens has been growing steadily. It now totals about $900 million annually, according to research firm IBISWorld.
The Associated Press, Washington Post and Los Angeles Times contributed to this story.
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"This is a big disappointment for us. They set the bar quite low," says Sonya Lunder, a senior analyst at EWG. Approximately 80% of today's sunscreens will pass the new test, but 20% to 30% of these wouldn't be allowed to go on sale in Europe because they don't have enough UVA protection (sunburns are primarily caused by UVB rays, but UVA rays contribute to skin cancer and premature aging).
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- All items in Category Noontime sun
- Most sunscreens actually increase the growth of skin cancer - May 2010
- Tanning from Wikipedia
- Overview Suntans and melanoma
- Shade is better than sunscreen – does not eliminate the vitamin D – June 2011
- Sunscreens which do not block UVB which makes vitamin D
- Sunscreens at WikiPedia
- Consumer Reports provides a nice annual review of Sunscreens - available online via most libraries
- Skin Cancer Organization good review of the science: UVA, UVB
- UV provides 2000 X more benefit than problem – 2006
Mercola 7 surprising things you're not supposed to know about sunscreen and sunlight exposure
- The FDA refuses to allow natural sunscreen ingredients to be used in sunblock / sunscreen products
- Nearly all conventional sunscreen products contain cancer-causing chemicals
- In a nation where over 70% of the population is vitamin D deficiency, sunscreen actually blocks vitamin D production
- You can boost your internal sun resistance by changing what you eat (astaxanthin)
- UV exposure alone does not cause skin cancer
- Not all "natural" sunscreen products are really natural
- Many "chemical free" sunscreens are loaded with chemicals
Has link to his June 2010 video The Truth About Sunlight, Cancer and Vitamin D