“In Korea, sunscreens are regulated as functional cosmetics versus the US where they’re regulated as over-the-counter drugs. The Korean Ministry of Food & Drug Safety (MFDS) is the regulatory authority, similar to the FDA, that’s responsible for creating and overseeing the sunscreen approval process. The approval process includes submitting clinical safety and efficacy documentation to the MFDS, which is far simpler than what the US requires. The testing and documentation is similar to what’s required in other global regions but the process is more efficient and can be done quickly.
In contrast, because the FDA treats sunscreen like a drug (and not a cosmetic), they have some of the most stringent requirements in the world, which requires extensive testing. As a result, the FDA in the United States has not greenlit any new UV filters since 1999. Notably, the FDA has recently mandated supplementary safety data for all previously approved chemical UV filters to uphold their market presence in the US.”
https://www.vox.com/culture/354545/korean-sunscreen-is-all-the-rage-if-youre-american-you-might-be-out-of-luck
“Sunscreen is regulated like a drug, which means the product is subject to byzantine FDA regulations that have largely thwarted innovation in the category for the last 20 years.
As the economist Alex Tabarrok has pointed out, European and Asian countries enjoy vastly superior options.
“Suncreens in Europe and Asia are better than in the United States because more ingredients are allowed and these create more effective and more pleasing suncreens,” he writes.
This is no accident, but rather the deliberate result of regulatory policy. The European Union, for instance, has approved 27 different compounds for use in sunscreen, whereas the FDA has only approved 17.
“The number of approved ingredients matters because not all filters can seamlessly be formulated into sunscreens or other suitable products for skin application,” writes the Cato Institute’s Gabriella Beaumont-Smith. “Moreover, some of the ingredients approved in the EU and Japan but not the US are more effective and long‐lasting.”
If the FDA won’t clear more sunscreen ingredients for use in the U.S., the agency should at the very least allow reciprocity: Foreign sunscreens could be made available with warning labels noting that they were approved by European health officials but not by the FDA. Of course, the best option would be for U.S. regulators to simply get out of the way and acknowledge that these products are obviously safe for human use. Indeed, not approving them is the greater danger, since using sunscreen is one of the best ways to prevent skin cancer.”
https://reason.com/2023/08/11/aoc-sunscreen-fda-regulation-tiktok-europe/