In a significant development for sun protection, the US Food and Drug Administration (FDA) has approved bemotrizinol, marking the first introduction of a new sunscreen ingredient in a quarter of a century. This long-awaited approval, announced on June 9, reflects ongoing efforts to enhance innovation in the skincare sector, particularly in the realm of sun safety.
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Bemotrizinol, a chemical compound that absorbs both UVA and UVB light rays, is already established in markets across Europe, Asia, Australia and Canada. With the FDA declaring it generally recognised as safe and effective, the ingredient can be used by adults and children aged six months and older. The announcement underscores the importance of robust sun protection, especially given that exposure to harmful UV rays is a known risk factor for skin cancer.
The active ingredient has been shown to be absorbed minimally through the skin, thus posing lower risks of systemic effects. The American Academy of Dermatology highlights the dangers of both UVA and UVB rays: UVA can lead to premature skin ageing while UVB is primarily responsible for sunburn. Importantly, UVA rays can penetrate glass, which means standard indoor environments are not necessarily safe from sun exposure.
Bemotrizinol was first included in sunscreen formulations in the European Union in 2000, and its regulatory approval by the FDA signifies a shift in the landscape of over-the-counter sun care products in the United States. It is noteworthy that this addition to the sunscreen monograph marks the first active ingredient incorporation since regulations were updated in the late 1990s.
Robert F. Kennedy Jr, Secretary of Health and Human Services, remarked on the implications of this approval, stating that the introduction of bemotrizinol will not only increase competition in the sunscreen market but also enhance consumer trust in sun protection products. With more options available, consumers will be better equipped to protect themselves against the detrimental effects of sun exposure.
The process for bemotrizinol’s inclusion initiated when DSM Nutritional Products, a European company, submitted a petition to the FDA to allow its use at concentrations of up to 6%. Following thorough examination, the FDA proposed the addition of bemotrizinol as a recognised active ingredient in sunscreens. It is anticipated that DSM Nutritional Products will market this ingredient under the brand name Parsol Shield, with a planned launch set for late 2026.
For the initial 18 months post-launch, DSM Nutritional Products will have exclusivity in selling sunscreens containing bemotrizinol. After this exclusivity period, other manufacturers will be permitted to utilise the ingredient, thereby increasing the variety of sunscreen options available to consumers.
Mike Davis, the Acting Director of the FDA Centre for Drug Evaluation and Research, praised this regulatory advancement as an example of progress achieved through the modernisation of FDA processes. He reassured the public of the agency’s commitment to ensuring access to effective and safe therapeutic options, particularly regarding over-the-counter products like sunscreens.
As bemotrizinol enters the US market, it holds the promise of enhancing skin protection measures for individuals of all ages. With rising concerns over skin health and the associated risks from UV radiation, the addition of this new sunscreen ingredient is a welcome advancement in the ongoing fight against skin cancer and sun damage. Consumers can look forward to a new era of effective sun protection just around the corner.