The U.S. has approved a new sunscreen ingredient for the first time in nearly 27 years, paving the way for anticipated changes in K-beauty sun care product development.
With the U.S. being the largest export market for K-beauty, the demand for sunscreens is expected to grow, leading to a rapid increase in inquiries from both domestic and international beauty brands. However, industry experts predict that actual product launches incorporating this new ingredient won’t gain momentum until the latter half of next year.
Ingredient Already Used in Europe and Asia; U.S. Allows Up to 6%
Industry sources reported on Wednesday that the U.S. Food and Drug Administration (FDA) added Bemotrizinol (BEMT) to its list of approved active sunscreen ingredients in June. The new regulations took effect on August 9.
This marks the first addition of a new sunscreen active ingredient in the U.S. since the late 1990s. BEMT, capable of blocking both UVA and UVB rays, has been a staple in sun care products across Europe, Australia, and Asia for decades.
Domestic cosmetic manufacturers (ODMs) have already developed products using this ingredient, accumulating valuable research and formulation expertise. The ODM industry reports that since the FDA’s approval announcement, approximately 80% of sunscreen-related inquiries from both domestic and international clients now focus on BEMT.
The U.S. market is already seeing product launches in response to this regulatory change. Australian sun care brand Ultra Violet released its Unblock Screen SPF 50, containing 3% BEMT, in the U.S. on August 31. This pioneering product is currently available online and will hit U.S. Sephora stores on September 2.
However, industry insiders anticipate that sunscreen products incorporating BEMT will likely enter the market en masse in the second half of next year, considering the time required for product stabilization and formulation development.
An industry spokesperson stated that following the approval announcement, it has seen a significant surge in inquiries and interest from global clients, with about 80% of sunscreen-related queries now focusing on BEMT. It expects the actual product applications to ramp up in the latter half of next year, after undergoing meticulous development processes for stabilization.
U.S. Regulatory Easing Could Expand Sunscreen Formulation Options, as the Country Remains the Top Export Market
BEMT’s previous absence from the U.S. market wasn’t due to safety concerns or prohibition. Rather, the FDA regulates sunscreens as over-the-counter (OTC) drugs, requiring compliance with specific active ingredients and usage conditions. BEMT simply wasn’t on this approved list until now.
Even ingredients widely used in Europe and Asia must meet U.S. safety and efficacy standards and undergo separate approval procedures to be used in sunscreens. This has resulted in a comparatively limited range of usable ingredients in the U.S. market, even as new sunscreen ingredients have proliferated globally.
As K-beauty continues its growth trajectory in the U.S. market, sunscreen exports have also increased. However, the divergent regulations on sunscreen ingredients often necessitated separate formulations for U.S. sales, differing from those used in Korea and Europe.
The domestic industry is particularly invested in this regulatory shift because the U.S. is K-beauty’s largest export market. They anticipate that the expanded options for developing U.S.-specific sunscreens will enhance their market responsiveness.
In the first half of this year, K-beauty exports to the U.S. reached 1.45 billion USD, accounting for 20.7% of total cosmetic exports and securing its position as the largest market. Within this, the export value of basic cosmetics, including sunscreens, hit 1.1 billion USD, marking a 48.6% increase from the previous year.
An industry representative noted that given that BEMT has been utilized in Europe, Australia, and Asia for decades, domestic companies have already amassed significant research and development experience. Korean sunscreens are highly regarded in the global market for their diverse formulations and moisturizing properties, positioning them to swiftly respond with new product developments for the U.S. market using this ingredient.
The industry views this development as significant not just for the approval of a single ingredient, but as an indication that U.S. sunscreen ingredient regulations, largely unchanged for decades, are finally evolving. If additional ingredients gain approval in the future, domestic companies may be able to expand the application of their existing sun care technologies to U.S. products.
An industry spokesperson commented that given the historical restrictions on many sunscreen ingredients in the U.S., the approval of a new ingredient is itself noteworthy. If this paves the way for further approvals, it anticipates a boost in the competitiveness of K-sunscreens and new opportunities for diverse product development.