Cosmax Receives US FDA Compliance Approval... Triples Sunscreen Production

COSMAX Hwaseong Factory Receives Fourth Compliance Approval
Sunscreen Production to Expand More Than Threefold
"K-Sunscreen Gaining Attention in Overseas Markets Including the U.S."

Global cosmetics original design manufacturing (ODM) company COSMAX announced on the 4th that it received approval for compliance regarding its manufacturing facilities and quality control systems after an OTC (over-the-counter) factory inspection by the U.S. Food and Drug Administration (FDA).

COSMAX plans to expand its global sunscreen market presence by increasing its sunscreen product lineup more than threefold this year.

Sunscreens are classified as over-the-counter drugs in the United States. Therefore, only products manufactured in factories that have passed the rigorous FDA OTC compliance approval process can be distributed and sold within the U.S.

COSMAX’s Hwaseong factory first obtained OTC product manufacturing approval in 2016 and has since received compliance approval a total of four times, including this latest one. In October of last year, the FDA visited the Hwaseong factory to conduct a comprehensive hardware inspection of the production site and quality facilities.

Based on the verified stability and technological capabilities from this approval, COSMAX plans to further expand its sunscreen market strategy. The company stated that the number of sunscreen products it manufactures this year is expected to increase more than threefold compared to the previous year.

Previously, COSMAX established an OTC lab last year. This was to respond to the entire OTC product manufacturing process from research to production, in line with the growth of the U.S. sunscreen market and the expansion of domestic client companies into the U.S. market.

COSMAX is diversifying OTC product formulations to suit the preferences of the U.S. MZ generation consumers, who favor light textures and various formulations. Representative products include sun serums, sun mists, and sun cushions.

A COSMAX official said, "As the need for sunscreen grows and becomes a daily routine due to climate change, K-Sunscreen products equipped with innovative technology are gaining attention in overseas markets including the U.S. COSMAX will establish itself as the number one partner for clients’ overseas expansion through continuous new technology development and thorough production and quality management."

Meanwhile, according to Euromonitor, the global sunscreen market size reached $14.7 billion (approximately 21 trillion KRW) last year, growing 16.5% compared to the previous year. Among this, the U.S. market, which ranks first in market size, accounts for 21.1% of the total, amounting to $3.1 billion (approximately 4.4 trillion KRW).

This content was produced with the assistance of AI translation services.