COSMAX announced on 4th that it recently received a suitable approval notice from the U.S. Food and Drug Administration (FDA) after an on-site inspection of its Over The Counter (OTC) factory.
COSMAX plans to use this as a stepping stone to expand its global sunscreen market strategy, increasing its sunscreen production items by more than three times this year.
According to Euromonitor, the global sunscreen market was valued at $14.7 billion (approximately 21 trillion won) last year, growing by 16.5% compared to the previous year. The largest market, the U.S., accounts for $3.1 billion (approximately 4.4 trillion won), representing about 21.1% of the market size.
Sunscreens are classified as over-the-counter drugs in the U.S. Therefore, only products manufactured in factories that have received FDA OTC conformity approval can be distributed and sold within the United States.
The COSMAX factory in Hwaseong received its first OTC product manufacturing approval in 2016 and has since received suitable approvals four times. The New Jersey factory (COSMAX USA) also maintains its approval for OTC product manufacturing, the company explained.
The FDA visited the Hwaseong factory in October of last year to conduct an overall hardware inspection, including production sites and quality facilities. It also reviewed the software sector, such as manufacturing and quality records, and testing methods for raw materials and finished goods, and recently notified its reauthorization decision.
With this approval, COSMAX plans to expand its market penetration in the sunscreen sector based on its verified safety and technological capabilities. This year, COSMAX's sunscreen production items are expected to increase more than threefold compared to the previous year. Currently, more than four times as many clients compared to last year are planning to collaborate with COSMAX to enter the OTC sunscreen market this year.