The results of these foundational studies confirm what has been suspected for a long time – that ingredients in sunscreen are absorbed into the bloodstream. The study didn’t determine – nor did it set out to – whether sunscreen is safe or unsafe. Further studies are needed to determine the clinical significance of the findings.

Spaulding Clinical Research was contracted by the FDA to gather data relating to the absorption of four commercially available sunscreen formulations into the bloodstream. We conducted a randomized clinical trial and found conclusive evidence that the four key ingredients we were tracking – avobenzone, oxybenzone, octocrylene and ecamsule – all were absorbed into the bloodstream.

We have already been contacted by companies wanting to have their products tested in relation to this study and we anticipate more needing to do so. More information on the FDA’s work in this area can be found here: Shedding New Light on Sunscreen Absorption

This type of clinical trial seeks to show the amount of active ingredient that enters the bloodstream after an amount is applied that matches what “maximum use” conditions would be. The May 2018 guidance from the FDA defines what a Maximum Usage trial needs to entail for Sunscreen products. All pharmaceutical companies with prescription products that are topically applied must also conduct a maximum usage trial on their product which has been a requirement for decades. Review the FDA’s statement on maximum usage.

There is an abundance of data about the harmful effects of exposure to the sun. Sunscreen has been shown to provide significant protection from these effects. We are aligned with the FDA’s position on sunscreen that “these results do not indicate that individuals should refrain from the use of sunscreen.”