GLOBAL AESTHETICS | JUL-AUG 2023 ISSUE

Are Foreign-Available Sunscreens Really Better?

OTC drug or cosmetic? It makes a difference.
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The use of topical sunscreens dates back to the time of ancient Egyptians, who used aloe vera, olive and lotus oil, inorganic clays, rice bran extracts, and mineral powders as photoprotectants. As dermatologists, a lot of us have been purchasing our sunscreens from abroad for years now, and our patients and the general public are catching onto our little secret. But what’s going on now with sunscreen?

UV Filters

In the US, sunscreen is considered an over-the-counter (OTC) drug whereas in other countries (Europe, Japan, India, Korea, Australia) it is considered a cosmetic product.

That is, in the US, UV filters are regulated as drugs and fall under the guidance of the FDA’s OTC sunscreen drug products monograph. In the countries in which sunscreen is regulated as a cosmetic, this makes for a quicker, less tedious and less costly approval process.

In the US, 17 filters are available for use. The last time the US had a new sunscreen filter approved was in 1999. Conversely, in the EU and Asia, there are at least twice as many filters available. However, worldwide, there are filters that are no longer commonly found in current sunscreen products despite approval: cinoxate, PABA, padimate O, trolamine salicylate, sulisobenzone, and dioxybenzone in the US and benzylidene camphor sulfonic acid, camphor benzalkonium methosulfate, polyacrylamidomethyl benzylidene camphor, Peg25 PABA, and benzophenone-5 in the EU.

Is More Necessarily Better?

In the US, the most popular physical (inorganic) sunscreens tend to be zinc oxide and titanium dioxide and chemical (organic) filters avobenzone, octisalate, octinoxate, octocrylene and homosalate. In other countries, there is more of an emphasis on broad spectrum chemical sunscreens that protect against both UVA and UVB rays. More specifically, these sunscreens offer enhanced UVA protection and visible light and hence can help protect against anti-aging. Such non-US-approved filters include Tinosorb S and Tinosorb M, Tinosorb A2B, TriAsorB, Mexoryl XL, as well as Uvinal A+. Bis-diethylaminohydroxybenzoyl benzoyl piperazine (BDBP) is a filter with UVA1 and visible light protection that has been shown to protect against hyperpigmentation. These new filters allow for increased efficacy but unless they are combined with elegant formulations, patients will hesitate to use them on a regular basis.

PA Rating System and Issues

The SPF rating that is given on sunscreen products in the US measures UVB rays. If a sunscreen is labeled as broad spectrum, it offers protection from UVA as well as UVB rays. Japan was the first country to start using a PA rating for UVA rays that is based on a test that causes persistent pigment darkening (PPD), that is, how long it takes for the skin to tan. The results are grouped into a rating system from PA+ to PA++++, with the latter offering the highest level of protection.

Yet, the PPD does not indication the exact amount of UVA protection that is provided and currently, there is no standardized system among countries that utilizes this system.

Where Do We Go from Here?

There is something to be said about the FDA’s important role in protecting us from harmful and potentially toxic products. Since 2021, UV filters in the US have been characterized in 3 categories: Generally recognized as safe (GRASE), not GRASE due to safety issues, or not GRASE as more safety data is required. In order to be GRASE, non-clinical animal studies as well as human trials need to be performed that that cover carcinogenicity, reproductive toxicity, sensitization and absorption. With such stringent safety standards, the FDA acts to safeguard citizens from possible adverse effects. When sunscreens are regulated as cosmetic products in other countries, human data may be reviewed but are not required for approval.

We tell our patients that the best sunscreen is the one that THEY will wear daily. As people become savvier, driven by information that is rapidly transmitted through the internet via Tik Tok and other social media, they may not get the entire picture of the regulatory process involved with UV filters. We live in a country with many freedoms and ubiquitous options. However, there are some people who prefer physical sunscreens because they may have skin sensitization or prone to allergic contact dermatitis from chemical ingredients. So, are sunscreens available outside of the US really better? It depends. Will you wear it every day?

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