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6 things to know about FDA’s new sunscreen regulations

First introduced in June 2011, the FDA is finally enforcing its new sunscreen regulations this month. Here's what retailers and manufacturers should know to ensure products are compliant—and even stay ahead of legislation—in time for holiday travel.

Jessica Rubino

December 7, 2012

5 Min Read
6 things to know about FDA’s new sunscreen regulations

The Food and Drug Administration (FDA) postponed the compliance deadline for its new sunscreen regulations, but the revised date of December 17 is fast approaching, putting heat on sun care manufacturers and retailers to make sure their products are compliant in time for holiday travel. Any over-the-counter (OTC) sunscreen products with annual sales of $25,000 or more must meet this deadline, while OTC sunscreen products with annual sales less than $25,000 have until December 17, 2013. 

First introduced in June 2011—and initially set to be implemented a year later—these sunscreen requirements address a range of marketing and formulation issues related to chemical and mineral products. Perhaps the most significant being that any company making "broad-spectrum” claims must now test for protection against UVA rays, in addition to UVB.

Here are a few more things to know about what these newly enforced regulations do (and do not) require—and how to stay ahead of the regulations to stock and manufacturer trusted products.

"Broad-spectrum" still isn’t foolproof

Many natural sun care companies using zinc and titanium dioxide already offer “broad-spectrum” protection from UVA (linked to skin cancer) and UVB (the cause of sun burns, shielded by a product’s SPF) rays. Zinc oxide, in particular, is one of the most effective broad-spectrum ingredients on the market, according to Sonya Lunder, a senior analyst with the Environmental Working Group (EWG). Under new regulations, all chemical and mineral sunscreens must test for protection against both types of harmful rays. However, as Lunder points out, these new requirements don’t necessarily mean a product is safe.

“We feel that the pass-fail test the FDA put into place for broad-spectrum protection is actually pretty weak and not setting a very challenging standard for products. Some of those products would not be sold in Europe where the threshold for sun protection and UVA protection in particular is higher,” she said.

The United States is using a pass-fail system that’s much easier to “pass” than the more advanced UVA star-rating system used in Europe. How to know if sunscreens offer adequate protection? The EWG Sunscreen Guide will continue to rank products on safety, including broad-spectrum UV protection. Plus, some brands such as W.S. Badger Co. have adopted the UVA star system used internationally to prove the extent of their UVA protection. 

No more bogus claims

"Waterproof," "sweatproof," or "sunblock" are all red flags—terms now prohibited under the FDA’s regulations. Sunscreens can make "water-resistant" claims but must tell how much time a user will get the SPF values while in water. The two "water-resistant" options are 40 minutes and 80 minutes.  

Chemicals still abound

Though these new regulations will help reduce misleading claims, they don’t regulate the ingredients used, some of which have raised significant health concerns.

Most recently, research shed light on new risks associated with common chemical sunscreen ingredient oxybenzone, ranked a high-hazard "8" in the EWG’s Skin Deep database. The study, published in Environmental Science & Technology, showed that benzophenone chemicals (including oxybenzone), may have stronger estrogenic activities than even bisphenol-A (BPA).

According to the study, a form of benzophenone called benzophenone-1, which forms when the body breaks down oxybenzone, was significantly associated with endometriosis. What’s more, the Centers for Disease Control reports that benzophenones are found in the urine of 97 percent of people.

Nano debate continues

Over recent years, nanoparticles have been a big topic in the sun care industry, where they’ve been used to improve protection and consistency of mineral sunscreens. Consumers have voiced concerns over the safety—and more specifically the absence of set definition or labeling requirements. 

The new FDA regulations do not address nanoparticles in any way, not from a formulation or a labeling standpoint. What may be most concerning is that without any regulations on these tiny particles, companies can say they’re non-nano without having actually tested their products.

The EWG maintains nanoparticles are safe in lotion form but advises against using nano-spray products. And a brand new study published in the Chemical Engineering Journal indicates an unforeseen risk associated with titanium dioxide sunscreen nanoparticles: Chlorine may strip titanium dioxide nanoparticles’ coating and react with water, forming compounds that could contribute to skin damage and even cancer, according to the 2012 study.

In the absence of labeling regulations or guidelines, the surest way to know the size of the particles used in your sun care is to contact the manufacturer directly or look on its website for more detailed formulation information.

Delivery systems called into question 

Though sunscreens in spray or powder form have gained popularity thanks to their convenience, these new FDA regulations shed light on their potential efficacy issues. When it comes to spray products, manufacturers must provide additional data to prove that these products are effective—and that they don’t pose risks if inhaled (concerns with chemical spray sunscreens and mineral spray sunscreens containing nanoparticles). Additionally, powder sunscreens will no longer be allowed.

SPFs limited 

A proposed FDA regulation would require sunscreen products with SPFs higher than 50 to be labeled SPF 50+ as opposed to listing the higher value. This is because there is not adequate data that shows SPFs of higher than 50 offer the additional protection indicated by high numbers.

Until this is enforced, avoid labeling or stocking products labeled as higher than SPF 50 to avoid misleading customers.

About the Author(s)

Jessica Rubino

Vice President, Content, New Hope Network

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