Sunscreen is a daily essential for protecting against premature aging and skin cancer, but in the United States, the selection of active sunscreen ingredients is surprisingly limited compared to the rest of the world. While European and Asian sunscreens feature cutting-edge UV filters, U.S. consumers are still using the same chemical sunscreens that have been on the market since the 1990s. This discrepancy is due to the FDA’s slow and stringent approval process, which has sparked an ongoing debate: Is the FDA protecting consumers by ensuring the absolute safety of these ingredients, or is its bureaucracy preventing Americans from accessing superior sun protection?
The Case for FDA’s Cautious Approach
The FDA regulates sunscreen ingredients as drugs, meaning that each new UV filter must undergo extensive testing for safety and efficacy before being approved for over-the-counter (OTC) use. While other regions treat sunscreen as a cosmetic product, the U.S. system subjects these ingredients to the same rigorous standards as pharmaceutical drugs. This process ensures that any new ingredient is thoroughly evaluated for potential risks, including skin irritation, hormone disruption, and long-term toxicity.
Protecting Consumers from Potential Risks
One of the primary concerns surrounding modern UV filters is their potential absorption into the bloodstream. A recent FDA study found that several common sunscreen ingredients, including oxybenzone and avobenzone, can be detected in the blood for extended periods. The FDA argues that it must gather sufficient data on the systemic effects of new UV filters before granting approval. This approach is particularly relevant in light of growing concerns over endocrine disruption and potential links between certain sunscreen ingredients and environmental harm.
Additional studies have raised questions about potential bioaccumulation and hormonal effects, although the evidence remains inconclusive. The FDA contends that without long-term human studies, it cannot determine the full impact of these chemicals on human health. Some sunscreen ingredients, such as 4-Methylbenzylidene Camphor (4-MBC), have been banned in parts of Europe due to safety concerns, which supports the FDA’s cautious stance on approving new filters.
Ensuring Comprehensive Safety Data
Unlike in Europe, where safety testing requirements vary and often rely on industry-funded studies, the FDA requires independent, extensive clinical trials before approving any new sunscreen ingredient. This meticulous process ensures that filters like Tinosorb S, Uvinul A Plus, and Mexoryl XL, which have been used in Europe for years, meet the highest safety standards before reaching U.S. consumers.
The pre-market approval system in the U.S. contrasts with post-market surveillance in Europe, where new ingredients can be used first and later removed if safety issues arise. This difference in regulatory philosophy highlights the tension between proactive safety measures and timely consumer access.
The Case Against the FDA’s Delays
While safety is a top priority, critics argue that the FDA’s outdated regulatory system is preventing access to better sun protection. Currently, only 16 active UV filters are approved in the U.S., while over 30 options are available in Europe. Many of the newer filters provide broader UVA coverage and greater photostability than those currently used in American sunscreens. This has led to frustration among dermatologists, consumer advocacy groups, and even some lawmakers, who believe that FDA bureaucracy is doing more harm than good.
Superior UV Protection Is Being Delayed
Broad-spectrum protection is critical for reducing the risk of skin cancer and premature aging, yet many modern UVA filters—such as Bemotrizinol (Tinosorb S) and Bisoctrizole (Tinosorb M)—are still unavailable in the U.S. These ingredients offer high photostability, minimal skin absorption, and superior protection against deep-penetrating UVA rays. By delaying approval, the FDA is limiting consumer access to more effective sun protection that is already widely used and considered safe in other parts of the world.
Consumers in Europe, Asia, and Australia have access to sunscreens with superior UVA protection, which helps prevent hyperpigmentation, collagen breakdown, and other signs of premature aging. Without these ingredients, U.S. consumers must rely on older, less effective UV filters like avobenzone, which degrades quickly in sunlight unless stabilized by additional chemicals.
The FDA’s Outdated Review Process
One of the biggest hurdles is the FDA’s failure to update its sunscreen monograph system. The last significant updates to U.S. sunscreen regulations occurred in the 1990s, and while the Sunscreen Innovation Act (2014) was meant to streamline approvals, it has done little to speed up the process. Of the eight new UV filters that were submitted for approval over a decade ago, none have been granted full FDA clearance.
The lengthy and expensive testing requirements discourage manufacturers from submitting applications. Companies that have successfully introduced new sunscreen ingredients abroad often choose not to invest in FDA approval, leaving U.S. consumers without access to these innovations.
Industry Reluctance to Navigate FDA Red Tape
Many companies have abandoned efforts to get their filters approved in the U.S. due to the costly and time-consuming nature of the FDA process. For example, BASF and DSM, two major chemical manufacturers, withdrew applications for several promising UV filters due to the FDA’s demand for additional long-term studies. As a result, many of the world’s best sunscreen formulations never reach the U.S. market, leaving American consumers with fewer choices and potentially inferior protection.
With an estimated 9,500 new cases of skin cancer diagnosed daily in the U.S., the demand for advanced sun protection is greater than ever. Many dermatologists argue that the FDA’s overly cautious stance may actually be contributing to higher skin cancer rates by restricting access to superior UV filters.
What Needs to Change?
To balance safety and accessibility, experts suggest that the FDA should adopt a tiered approval system that allows ingredients that have been safely used in Europe and Asia for decades to be fast-tracked for review. Additionally, the FDA could work more closely with dermatologists and global regulatory agencies to assess real-world safety data rather than waiting for costly new clinical trials to be conducted in the U.S.
There is also a push for greater transparency in the approval process. Consumers and industry leaders have long called for clearer timelines and standardized testing requirements so that companies can more efficiently bring new UV filters to market without sacrificing safety.
Some experts suggest that allowing a provisional approval system—where ingredients can be used while undergoing further safety testing—might be a viable compromise. This approach would enable consumers to benefit from advanced sunscreen formulations without waiting decades for bureaucratic approvals.
The Future of U.S. Sunscreen Innovation
Change may be on the horizon. In 2021, the FDA released a proposed rule re-evaluating several existing sunscreen ingredients, including oxybenzone and octinoxate, due to concerns over their potential risks. At the same time, Bemotrizinol (Tinosorb S) is currently undergoing FDA review and could become the first new U.S. sunscreen filter approved in decades.
Ultimately, the debate comes down to a question of risk versus benefit. Is the FDA’s stringent approval process protecting public health, or is it preventing Americans from accessing safer, more advanced sunscreen formulations? As skin cancer rates continue to rise and global innovation in UV protection advances, the pressure is mounting for the FDA to modernize its approach and ensure that U.S. consumers have access to the best possible sun protection.
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