Is Litigation on the Horizon for Sunscreen Manufacturers?

Posted by on June 25, 2019

On May 6, 2019, a study published in the Journal of the American Medical Association reported that several sunscreens used under maximal conditions resulted in plasma concentrations of active ingredients that exceeded the threshold limit established by the U.S. Food and Drug Administration (FDA). The fact that an ingredient is absorbed through the skin and into the bloodstream does not necessarily mean that it is unsafe. However, plaintiff’s attorneys may seize upon these results to recruit individuals who believe that they were harmed by using sunscreens.

Absorption of Sunscreen After Topical Application

Using four commercially available sunscreens, FDA scientists determined whether four active ingredients (avobenzone, oxybenzone, octocrylene, ecamsule) were absorbed into the bloodstream. For four days, individuals applied one sunscreen product (lotion, cream, or spray) to 75% of their body surface area four times per day.

After four applications, plasma concentrations of all four ingredients in all four products exceeded the threshold limit of 0.5 ng/mL established by the FDA for over-the-counter sunscreens. Levels increased over four days of use, with three of the four ingredients remaining elevated several days after sunscreen use ended.

It is important to note there are several important limitations associated with this study. First, differences in absorption relative to product formulation, skin type, or age were not assessed. Next, the study was conducted indoors without exposure to sunlight, heat, or humidity, all of which could affect the rate of absorption. Finally, the products were applied in excess of what is considered typical usage.

Nevertheless, according to the FDA, ingredients absorbed in excess of 0.5 ng/mL after a single dose are recommended for toxicological testing. Consequently, a second phase of study is planned to examine plasma concentrations of these ingredients after one application of sunscreen and long-term levels after last use, as well as other common sunscreen ingredients.

Sunscreens Generally Recognized as Safe and Effective

Earlier this year, the FDA recommended additional research on 14 common ingredients found in non-prescription sunscreens, as well as newly proposed labeling requirements for sunscreen products. However, the agency emphasized:

[T]his proposed rule does not represent a conclusion by FDA that the sunscreen active ingredients…are unsafe for use in sunscreens. Rather, we are requesting additional information on these ingredients so that we can evaluate their GRASE status [generally recognized as safe and effective] in light of changed conditions, including substantially increased sunscreen usage and exposure and evolving information about the potential risks associated with these products since they were originally evaluated.

Likewise, although additional testing is needed to determine the clinical significance of the current study results, there is no indication that individuals should refrain from the use of sunscreen. Sunscreens have been used for decades and to-date there have been no reported internal harmful effects from their use. In the current study, the most common adverse event was rash.

Is Litigation on the Horizon?

In the days since publication, this study has been widely reported by mainstream media and social media outlets. Additionally on June 9th, Senator Chuck Schumer sent a letter to the FDA urging increased scrutiny of sunscreen ingredients.

Although it remains to be seen if the sunscreen industry will become the next target of litigation, as of writing this post at least two plaintiff-friendly websites (such as here and here) were hyping the results. In toxic tort cases, it is not uncommon for plaintiffs to allege personal injury due to low levels of exposure to a compound, even in the absence of controlled evidence (for example, see our recent blog on PFAS litigation here).

Innovative Science Solutions continues to monitor this story, as well as the  FDA’s proposed recommendations and labeling revisions for sunscreen products.

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