New FDA sunscreen rules require more protection, fewer claims
posted by: Guest Blogger
You’re an SPF 30 kind of person — cautious, but not meek; edgy, but not reckless, like those SPF 15 hedonists.
But this summer your identity may grow a bit more complicated.
Thanks to new rules by the Food and Drug Administration, manufacturers no longer can emblazon their bottles and squeeze-tubes with SPF-related marketing jargon (Waterproof! All-Day Protection!) and be done with it. Instead, the labels also must declare the product has passed “broad spectrum” tests that measure the lotion’s ability to protect against two key kinds of ultraviolet rays — UVB rays (the ones that SPF refers to) and now also UVA rays, the light that sinks deeper into the skin and, like UVB rays, contributes to cancer and signs of aging.
In addition, that old-school label that called your SPF 30 “waterproof” will be a no-no in months. Sunscreens can be only “water-resistant,” and the labels will spell out how long they will stand up to water: either 40 or 80 minutes. Sunblock? No such thing anymore, either. It’s called sunscreen.
Finally, get used to words — and lots of ’em — on the backs of the bottles, in the drug-information boxes. Now you will know every last ingredient you are slathering on your skin.
The FDA’s fresh involvement in the industry is welcome and long-overdue, said University of Colorado Medical School dermatology professor Theresa Pacheco.
“There is not a day in clinic that somebody doesn’t ask me, ‘What kind of sunscreen should I use?’ This levels the playing field,” she said. “We know protection against light can protect against cancer, against aging. One of the best ways to keep yourself looking great forever is wearing sunscreen. It has been frustrating for us dermatologists. These companies remarket and rebrand their sunscreens every year, they put a new spin on it every year.”
The change, effective June 14, isn’t just a matter of semantics. To pass FDA muster, companies must engage in extensive testing to prove their products protect against “broad spectrum,” and that they can continue to work, while wet, for 40 or 80 minutes.
The testing isn’t cheap. Neither is the new packaging — by this summer, every bottle of sunscreen must have new labels.
“We are a $2 million company, and it will probably cost us between $50,000 and $70,000. That is a huge undertaking,” said Sean Zimmerman, a manager with Rocky Mountain Sunscreen in Arvada. “I think a lot of smaller companies might not be able to make the change.”
The expenses will likely raise prices next year, Zimmerman said. But he also called the FDA’s new regulatory regime “a good thing.”
“It should help the consumer,” he said. Good riddance, he added, to the blizzard of vague marketing terms widely used in the past.
The only downside: The FDA hasn’t yet approved a laundry list of sun-protecting ingredients that are widely used in Europe. For now, most products will depend upon at least one of a pair of active ingredients to protect against ultraviolet rays, Zimmerman said: zinc oxide and avobenzone. Formulas will contain a host other ingredients that affect everything from water resistance to odor, but they don’t offer sun protection.
Long time coming
The FDA rules weren’t a big surprise. Officials with the federal agency have talked about regulating the sunscreen industry more forcefully since the 1970s, and sunscreen makers have been involved with the process all along.
The point of the new rules, said FDA spokesman Devin Koontz, is to wade more deeply into some of the medical concerns associated with sun exposure. In the past, he wrote in an e-mail, FDA rules focused on sunburn, which is primarily caused by UVB radiation and can lead to cancer. But protection against UVA is vital, he wrote, because it also “contributes to skin cancer and aging.”
“After reviewing the latest science, FDA determined that sufficient data are available to establish a broad spectrum-test for determining a sunscreen product’s UVA protection,” Koontz added. “Passing the broad spectrum test shows that the product provides UVA protection that is proportional to its UVB protection.”
At Goddess Garden in Longmont, a sunscreen company that uses all-natural ingredients in its lotions — for its active sun-screening ingredient, Goddess Garden depends on the mineral zinc oxide — the FDA rules will drain corporate coffers by $50,000 or more, but company science guru Paul Halter said the changes make sense for consumers.
One big challenge: Those words that now must be squeezed into a drug-information box.
The formulas can involve a lot of ingredients, and some sunscreen containers are awfully small.