EWG Endorses Mineral Sunscreens, Avobenzone And UVA-Protective Chemicals Stranded In Europe

Three-fourths of sunscreens marketed in the US offer “inferior” protection or contain “worrisome” chemicals, according to the Environmental Working Group’s 2020 Sunscreen Guide. The guide shows overwhelming preference for mineral over chemical sunscreens, while also suggesting that Americans would be better off if UVA-protective chemical filters in Europe were allowed stateside.

Acceptable sunscreens on the US market have fallen to 25% in the Environmental Working Group’s 2020 Sunscreen Guide, down from around 33% of evaluated products last year.

Oxybenzone was in around 40% of the 1,300 sunscreens reviewed, accounting for a good portion of the fails.

The group maintains that oxybenzone is allergenic, readily absorbed, a potential endocrine disruptor and a danger to children.

Generally, EWG – whose annual sunscreen guide has been running for over a decade – continues to recommend mineral sunscreens containing titanium dioxide (TiO2) and/or zinc oxide (ZnO). The latter is one of just two UV filters permitted for use in the US that afford meaningful UVA protection, the group says.

The second strong UVA absorber, avobenzone, is present in sunscreens that EWG recommends, as are chemical filters used to stabilize the ingredient, such as octocrylene and octisalate.

However, all chemical UV filters on today’s US market were categorized either as not generally recognized as safe and effective (GRASE) or as requiring additional data (Category 3) in the Food and Drug Administration’s February 2019 proposed rule to establish a final OTC monograph for sunscreen drug products. (Also see "'Data Gaps' Keep 12 Ingredients Off FDA's Proposed OTC Sunscreen Monograph" - HBW Insight, 21 Feb, 2019.)

That makes EWG wary.

But in its view, avobenzone’s safety profile is less concerning than others on the Category 3 list. For example, avobenzone was not nearly the highest-absorbed sunscreen chemical in a bioavailability study the FDA published in January 2020 – oxybenzone was. (Also see "FDA’s Follow-Up Sunscreen Trial Shows More Of The Same: Absorption Of All Tested UV Filters" - HBW Insight, 21 Jan, 2020.)

And avobenzone does not pose the same hormonal concerns that have been linked to oxybenzone, or octinoxate or homosalate, though both avobenzone and oxybenzone are associated with relatively high rates of skin allergy, according to EWG.

The FDA found that all six of the chemical UV filters it evaluated in the absorption study – avobenzone, oxybenzone, octocrylene, homosalate, octisalate and octinoxate – when applied topically, can make their way into the body.

“These findings are troubling,” EWG says, “because they show that sunscreen chemicals are circulating in the blood, and the FDA has indicated that the agency does not have enough information to determine whether the chemicals are causing harm.”

“It is unfortunate that at precisely the time that COVID-19 stay-at-home orders are being lifted and Americans may be heading to beaches and pools, EWG’s 2020 Guide to Sunscreens attempts to needlessly scare consumers with false claims and misinformation.” – PCPC’s Alex Kowcz

On the other hand, in its proposed sunscreen rule the FDA says existing data are sufficient to show that ZnO “does not penetrate into or through human skin to any great extent and, to the extent any de minimis penetration occurs, does not result in adverse health effects, given the high levels of endogenous zinc in the human system.”

ZnO and TiO2 are the only two UV filters on the US market that the FDA deemed GRASE in its proposed rule. The vast majority if not all of the highest-rated sunscreens in EWG’s shopping guide – 1s on the NGO’s 1-10 hazard scale – rely exclusively on ZnO and/or TiO2.

According to EWG, 50% of the sunscreens it assessed for the 2020 guide contained one or more of the 12 chemical UV filters the FDA’s proposed rule flagged as needing additional testing.

A federal COVID-19 relief package signed into law in March included a rider for long-sought OTC monograph reform, essentially rebooting the FDA’s considerations of sunscreen drug ingredients.

The Coronavirus Aid, Relief and Economic Security (CARES) Act requires a revised sunscreen order from the agency within 18 months of the legislation’s enactment, under the auspices of a new OTC drug review process that replaces the lengthy notice-and-comment rulemaking that bogged down the program in the past.

EWG notes, “Now the law requiring the FDA to finalize sunscreen rules has been rewritten,” adding, “The FDA is likely to propose the same changes again.”

‘Americans Are Being Shortchanged’

Much is made in EWG’s 2020 Sunscreen Guide about the inadequate UVA protection provided by sunscreens marketed in the US, particularly when compared with those available in Europe.

“Americans have fewer choices and notably poorer protection than Europeans do from ultraviolet A rays in their sunscreen options. Although most US sunscreens prevent sunburn effectively when used correctly, they aren’t as good as European sunscreens at preventing the more subtle skin damage produced by lower-energy UVA radiation,” EWG says.

The NGO is critical of high-SPF products in the states in large part because UVA protection tends not to increase proportionately with UVB defense, making users susceptible to long-term skin damage and cancer risks as they potentially expose themselves to sun longer in the absence of sunburn, it says.

The FDA’s proposed sunscreen rule included changes to its broad-spectrum testing requirements that would have addressed the issue by yoking higher SPFs to increases in both UVB and UVA protection.

EWG notes, however, that without updates to sunscreen manufacturers’ active ingredient toolkit, UVA protection increases would be difficult to achieve. Instead, SPF values likely would have to come down, a development that EWG ostensibly would welcome, at least as an interim solution.

“Avobenzone and zinc oxide are the only allowed ingredients that provide good UVA shielding. Nearly every non-mineral product with SPF of 30 or higher uses avobenzone at the maximum concentration of 3%. As the SPF in these products increases, the UVA protection does not increase proportionally,” the group says.

It adds, “American sunscreen manufacturers may not be able to improve UVA protection until the FDA caps SPF values and approves the new, modern filters used in Europe.”

Those modern UV filters available to Europeans include bemotrizinol (trade name Tinosorb S), bisoctrizole (Tinosorb M), ecamsule (Mexoryl SX) and drometrizole trisiloxane (Mexoryl XL), all of which appear to be more effective UVA absorbers than avobenzone, according to EWG.

The NGO notes that manufacturers have attempted to obtain GRASE decisions in order to use those filters in sunscreens in the US. However, the FDA determined in each instance that additional data were needed to allow for GRASE decision making. (Also see "FDA Sunscreen Guidance: Absorption Data Is A MUsT For GRASE Review" - HBW Insight, 28 Nov, 2016.)

“Some information the FDA wants, such as complete copies of studies, might be easy for sunscreen makers to produce. But in other cases, the companies could take years to satisfy FDA requests. In the meantime, Americans are being shortchanged,” EWG says.

The group recognizes that the FDA has requested the same types of data for the next-generation, UVA-protective ingredients vying for US entry as it has for chemical filters currently marketed stateside that are receiving fresh looks, including avobenzone, oxybenzone and others.

It may be difficult for some to reconcile EWG’s seeming bias against existing chemical UV filters that the FDA says require data, and its apparent eagerness to usher new chemical filters onto the US market that the FDA says require data.

It is fairly clear that the regulatory bar for sunscreen marketing in the US, where sunscreens are regulated as drugs, is substantially higher than that in the EU, which treats sunscreens as cosmetic products. Permitted UV filters, backed by favorable safety opinions from the European Commission’s Scientific Committee on Consumer Safety, are listed in Annex VI of the bloc’s Cosmetics Regulation.

EWG seems confident in the safety of certain next-generation UV filters sold in Europe, including drometrizole trisiloxane, which it says shows low absorption, no evidence of hormone disruption and low allergenic potential.

“For the time being,” EWG says, “inferior products will remain on [US] store shelves” until the FDA implements changes to the regulatory framework that it proposed previously and industry provides the agency with missing data.

PCPC Fires Back

The Personal Care Products Council issued a rebuke on 22 May.

Chief Scientist Alexandra Kowcz states, “It is unfortunate that at precisely the time that COVID-19 stay-at-home orders are being lifted and Americans may be heading to beaches and pools, the Environmental Working Group’s (EWG) 2020 Guide to Sunscreens attempts to needlessly scare consumers with false claims and misinformation that can be potentially harmful to public health.”

According to the trade association, EWG’s sunscreen ratings imply safety conclusions that the FDA has not reached in its sunscreen rulemaking efforts, particularly with regard to oxybenzone and other chemical UV filters previously designated Category 3.

PCPC rejects the notion that three-fourths of sunscreen products on the US market offer “inferior” protection or contain “worrisome” ingredients.

“FDA requires rigorous testing for sunscreen effectiveness (both Sun Protection Factor [SPF] and Broad Spectrum). Consumers can be confident that these reliable and credible testing methods that are well recognized by experts and regulatory authorities across the globe result in sunscreens that are safe and effective in protecting them from harmful UV rays,” Kowcz says.

She adds, “The methods used by EWG have not been subject to scrutiny or approval by any scientific or regulatory agency.”