The United States has approved a new sunscreen ingredient, bemotrizinol (BEMT), marking the first such approval in the 21st century and the first in nearly three decades. This ingredient, already available in Europe and Asia, was previously hindered from reaching American consumers due to the US Food and Drug Administration's (FDA) regulation of sunscreens as over-the-counter drugs, which involves a more rigorous approval process than for cosmetics.

In response to delays in regulatory updates, Congress mandated the FDA to reform its sunscreen approval process in 2020. DSM Nutritionals, a manufacturer of a bemotrizinol-based sunscreen, submitted an application in 2024. Following a review of safety and efficacy data, bemotrizinol received approval, a development lauded by the Environmental Working Group as a "monumental victory for health and wellness." Dermatologist and assistant professor at the University of Texas at Austin, Dr. Adewole Adamson, noted the significance, stating, "We haven’t been able to really have any innovation in US-based sunscreens since last millennium."

This approval comes at a time when sunscreen use in the US has seen a slight decline, coinciding with rising concerns about sunscreen absorption into the body and potential adverse health effects. BEMT proponents hope its broad-spectrum protection, more appealing application, and reduced skin penetration will help reverse this trend.

Understanding Sunscreen and Safety Concerns

Sunscreen protects against UVA and UVB ultraviolet rays, both of which can cause skin damage. "Broad spectrum" sunscreens are recommended as they offer protection against both types of rays, typically achieved by combining multiple active ingredients or filters. These filters can be either mineral (zinc oxide, titanium dioxide) or chemical. While both types are effective, they have different characteristics: mineral sunscreens can leave a white residue, and chemical sunscreens have faced scrutiny regarding safety.

A shift in public perception began in 2019 when the FDA revised its safety assessment of common sunscreen ingredients. While mineral sunscreen ingredients were deemed generally safe, several chemical sunscreen ingredients were flagged for insufficient data, and two were deemed unsafe. Around the same time, research emerged suggesting that certain chemical sunscreen ingredients could be absorbed into the bloodstream in significant concentrations, raising questions about long-term health impacts. This led to increased skepticism and a rise in anti-sunscreen advocacy, with some individuals reducing or ceasing sunscreen use despite its proven effectiveness in preventing skin cancer.

Bemotrizinol's Advantages

Bemotrizinol offers broad-spectrum protection against both UVA and UVB rays on its own. Adamson described it as potentially more "cosmetically elegant," meaning it is less likely to leave the white residue characteristic of many mineral sunscreens. This improved aesthetic could encourage greater consumer adoption.

The ingredient is also expected to alleviate some of the safety concerns that have fueled sunscreen skepticism since 2019. The aforementioned 2019 JAMA study highlighted the absorption of certain chemical sunscreen ingredients, leading to public apprehension. Adamson stated that preliminary clinical trial evidence suggests BEMT does not reach the same concentrations in human plasma. Having been used for decades in other countries with a strong safety record, BEMT's approval in the US underscores the rigorous standards of the FDA's drug classification.

Availability and Recommendations

DSM Nutritionals will hold exclusive rights to market its bemotrizinol formulation, Parsol Shield, in the US for 18 months. After this period, other companies will be able to incorporate the ingredient into their products. Consumers can identify it by checking for bemotrizinol or BEMT on ingredient lists.

Regardless of the specific ingredient, experts emphasize the importance of Sun Protection Factor (SPF). An SPF between 30 and 50 is generally recommended, providing approximately 98 percent protection against the sun's rays. It is important to note that SPF levels above 50 offer minimal additional protection. Advocates hope that the introduction of BEMT will help restore consumer confidence in sunscreen, a critical tool in preventing skin cancer, which remains the most commonly diagnosed cancer in the United States.