It's been more than a year

We're happy to report that the FDA's new rules on sunscreen addressed some of the issues we raised in our coverage, and nothing in the FDA's update contradict any of its main points. Still, many people are going to feel that the FDA did not go far enough with its new rules -- especially since these are the first major changes it has made in almost two decades.



So what did the FDA achieve with its new regulations that begin to go into effect next year and will be fully required of all sunscreen makers by 2013?



Most importantly perhaps, it ruled that sunscreens can no longer claim they are "sunblocks." Since no sunscreen can block all of the sun's harmful rays, the FDA ruled, that term is patently misleading. Nor will it allow sunscreens to claim they are "sweatproof" or "waterproof" for the same reason. Sunscreens will be permitted to say they are "water resistant" but they must show immersion test data to support 40-minutes or 80-minutes protection to indicate just how long they'll be effective before a re-application will be needed.

"...people need to use more sunscreen and reapply it more often for best protection, regardless of what SPF is shown on the bottle."

Similarly, the FDA will insist on some clarity about claims of "broad spectrum" protection. Only sunscreens that protect against both UVB and UVA rays will be permitted to bill themselves that way. And their SPF rating must be backed by test data that shows they offer protection that is proportional for UVA wavelengths, which has not been the case prior to this because SPF ratings were based solely on UVB testing.The FDA did not insist, as many consumer groups had advocated, on banning SPF claims greater than 50+ even though higher ratings may lead some users to conclude, mistakenly, that they are getting vastly more protection the higher up the scale they move and can therefore spend much longer in the sun without worry.The implication here, not specifically stated in these FDA rules, is that people need to use more sunscreen and reapply it more often for best protection -- just as we recommended last year -- regardless of what SPF is shown on the bottle. Then as now, we suggest a broad spectrum, water resistant sunscreen of minimum SPF 15, and preferably SPF 30 or 50 applied 15 minutes before exposure and reapplied frequently. For full body coverage, about a shot glass full -- three or four tablespoons -- is needed at each application.The FDA did not address concerns that several watchdog groups have raised over nano-particles of zinc oxide and titanium dioxide found in many modern sunscreens that are so small they might be absorbed into living cells or into the bloodstream. Here, the FDA's position remains unchanged: that differences of scale do not make these already approved ingredients any more risky. Dr. Janet Woodcock, director of the FDA's drug center, told thethat tests showed no evidence "that these particles are getting into the body." Even so, sunscreen labels of the future will be required to state that sunscreens should not be used on "broken or damaged skin."Nor did the FDA take any steps to make changes to which chemical compounds it approves for use in sunscreens, although it has indicated it will revisit the latest research data to indicate if changes are necessary in the future. No word on when that may happen. The new rules also do nothing to speed the approval of more than two dozen chemical compounds that are already being used in Europe and Japan, even though there is evidence that many of them have proven to be highly effective, especially in UVA protection.As far as they go, the new FDA rules on sunscreens will help consumers to make better choices, especially those who haven't bothered to educate themselves about the key attributes and differences in sunscreen products. But despite its 46 pages, about half of which are devoted to labeling and half to testing standards, there are still lingering questions that remain unanswered. In its short form summary FAQs for concerned citizens the FDA concludes, just as we did in our articles last year, "the risk of not using sunscreen is much greater than any potential risk posed by sunscreen ingredients." Read more from that summary here True, some of the material is difficult and technical, but the more you know about sunscreen, the better informed you will be in keeping yourself safe from the damaging effects of the sun. The FDA has taken a step forward to help in that direction, but it's clear there's yet more to be done -- and for much of that you're still on your own.