Why Doesn't the United States Allow More Sunscreen Filters?
Sunscreen is a crucial part of skincare, offering protection against harmful UV rays that can lead to skin damage, premature aging, and even skin cancer. While many countries around the world have approved a wide variety of sunscreen filters, the United States has a much more limited selection. Despite new innovations and advancements in sunscreen technology, the U.S. Food and Drug Administration (FDA) has been slow to approve new sunscreen ingredients. So, why does the U.S. lag behind in sunscreen filter approval, and what are the implications for consumers?
The FDA's Strict Approval Process
The primary reason the U.S. doesn’t allow more sunscreen filters is the FDA's rigorous and complex approval process. The FDA regulates sunscreen ingredients as over-the-counter (OTC) drugs, which means they must undergo extensive testing to prove their safety and efficacy before they can be marketed. This process is far more stringent than in many other countries, where sunscreens are typically treated as cosmetics rather than drugs.
The approval process includes:
Extensive Safety Testing: The FDA requires data on long-term safety, potential side effects, and any interactions with other ingredients.
Efficacy Trials: Sunscreens must prove their ability to effectively block UV rays and reduce the risk of sunburn, skin aging, and cancer.
Regulatory Delays: The approval process can be long, with ingredients often taking years to be reviewed, tested, and eventually approved or rejected.
This means that many sunscreen filters, which have been in use for years in Europe, Asia, and other regions, are still awaiting FDA approval in the U.S.
Examples of Approved vs. Unapproved Filters
While sunscreens in the U.S. commonly contain ingredients like zinc oxide, titanium dioxide, avobenzone, and oxybenzone, many other widely used filters are not approved for use in the U.S.
Approved Filters in the U.S.
Zinc Oxide and Titanium Dioxide (mineral filters)
Avobenzone, Oxybenzone, Homosalate, Octocrylene (chemical filters)
Unapproved Filters in the U.S.
Tinosorb S and Tinosorb M (both offer broad-spectrum UVA/UVB protection)
Mexoryl SX (advanced UVA protection)
Uvinul A Plus (UVA protection)
Ecamsule (a powerful UVA filter used in Europe)
These unapproved filters are considered safer, more stable, and more effective by many international dermatologists, but they are still awaiting FDA evaluation.
Why the Delay?
Rigorous Safety Testing The FDA requires detailed safety data, particularly on how long-term exposure to a sunscreen ingredient may affect skin health, hormonal balance, or the environment. Some ingredients, such as oxybenzone, have been under scrutiny due to concerns about their absorption into the bloodstream and potential endocrine-disrupting effects. While other countries may allow these ingredients based on international safety reviews, the FDA's conservative stance prioritizes additional studies and data.
Slow Regulatory Process Sunscreen filters that are approved in Europe or Asia often face years of delays before being considered in the U.S. regulatory process. The FDA operates under limited resources and has a backlog of sunscreen ingredient submissions, meaning that new products take much longer to gain approval.
Environmental Concerns Environmental concerns, especially regarding coral reefs, have also contributed to the slow approval of certain sunscreen filters. For example, oxybenzone and octinoxate have been banned in several U.S. states, including Hawaii and Florida, because of their potential harm to marine life. The debate surrounding the environmental impact of sunscreens may influence the FDA’s caution in approving new filters that could have similar effects.
Lack of Urgency The U.S. public health system tends to prioritize other health risks over skin cancer prevention. While skin cancer rates are high, sunscreen is just one of many preventive measures, and some may view it as less urgent compared to other public health issues. As a result, sunscreen innovation doesn’t always receive the level of attention or funding it deserves.
The Impact on U.S. Consumers
The limited availability of sunscreen filters in the U.S. means that American consumers may not have access to the safest or most effective products available elsewhere. Many sunscreen filters used in Europe and Asia are considered superior in terms of both performance and skin compatibility. For example, Tinosorb S and Mexoryl SX provide exceptional UVA protection and are highly photostable, making them ideal for daily use. Without these ingredients, U.S. sunscreens may not offer the same level of broad-spectrum protection, leaving consumers with fewer options for effective sun protection.
Additionally, the lack of newer, more advanced filters limits the cosmetic appeal of many U.S. sunscreens. Mineral sunscreens, which are commonly used in the U.S., can leave a visible white cast and may feel thick on the skin, whereas chemical sunscreens with newer filters tend to feel lighter and more comfortable to wear daily.
Recent Efforts to Approve More Filters
The FDA has recently taken steps toward modernizing its approach to sunscreen regulation. In 2021, the FDA proposed updates to sunscreen regulations, including considering more modern ingredients for approval. It is expected that new filters will be reviewed in the coming years, but the process remains slow.
Advocacy from dermatologists, the sunscreen industry, and consumer protection groups may eventually push the FDA to streamline its approval process and allow more sunscreen filters to be used in the U.S. Until then, consumers will have to navigate the limited options available, many of which are outdated compared to what is offered globally.
