The U.S. sunscreen market is set to open up after two decades of strict regulations. The Food and Drug Administration (FDA) has announced a relaxation of its long-standing rules on sunscreen ingredients, which is expected to benefit the North American expansion of the K-beauty sector, particularly in sun care products.
According to industry sources, the FDA recently granted final approval for the ingredient 'Bemotrizinol' as an active component in over-the-counter (OTC) sunscreens, with the new regulations taking effect on August 9. Bemotrizinol is the first new active ingredient added to the OTC sunscreen list since the late 1990s.
Bemotrizinol blocks both UVA and UVB rays. While it has been used for years in Europe, Australia, and parts of Asia, it was not previously permitted in the U.S., limiting its application in products.
In the U.S., products with sunscreen properties are classified as OTC drugs, unlike in South Korea, where they are considered general cosmetics. This means that manufacturers must comply with FDA regulations regarding permitted ingredients, concentrations, labeling, testing methods, and manufacturing standards.
As a result, domestic brands have had to develop separate formulations for global and U.S. markets. If a domestic product contained ingredients not approved in the U.S., it required redesigning the formulation and conducting separate efficacy and safety tests. This led to increased development costs and delayed product launches.
With this approval, domestic companies can now utilize their expertise in Bemotrizinol formulations for products intended for the U.S. market. ODM companies like Kolmar Korea and Cosmax are likely to see increased demand for product redesigns and new sun care developments from existing clients. K-beauty brands targeting the U.S. market, such as The Founders (Anua), Gudai Global (Chosun Beauty), and Dalba Global (Dalba), along with local sales channels like Olive Young, will also be able to expand their product lines.
Lee Kyo-seok, a researcher at Shin Young Securities, stated, "We expect Kolmar Korea to see an increase in sun care orders due to the easing of Bemotrizinol regulations in the U.S., and the company is likely to benefit significantly from its technological competitive edge starting in the second half of this year."
The U.S. is the largest export market for K-beauty products. According to the Ministry of Food and Drug Safety, South Korea's cosmetic exports to the U.S. reached $1.45 billion in the first half of this year, a 41.5% increase compared to the same period last year. The U.S. accounts for 20.7% of total cosmetic exports, maintaining its position as the largest export destination. Last year, the U.S. surpassed China to become the top export market for cosmetics and has retained that status in the first half of this year.
An industry insider noted, "Given that domestic companies have accumulated substantial formulation data on Bemotrizinol over the years, they can demonstrate a competitive advantage in product development speed and quality. We expect inquiries and new orders from global clients to gradually increase starting in the second half of the year."
* This article has been translated by AI.
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