Cosmax gets FDA certification to export sun protection products

Cosmax Inc., a South Korean cosmetics developer and manufacturer, said on Monday it has received both product and consumer health certification from the U.S. Food and Drug Administration, meaning all products coming from its Korean plant can be marketed in the U.S.

Korea and the U.S. vary in classification of cosmetics. Some products approved as cosmetics in Korea should be approved as consumer health products that are traded without a doctor’s prescription in the U.S. Sun cream and spray products are a point in case. The U.S. and other advanced countries classify sun protection products as consumer health products. Korean manufacturers need a consumer health certificate to export these products.

Cosmax has prepared for the FDA certification since 2014 to better respond to rising demands from global customers. An FDA inspection team visited the company’s plant to review the whole manufacturing process from raw material warehousing to finished product shipment, as well as a quality control system. The approval came one year after the company began the preparation.

A company official said Korean companies have so far received an FDA certificate for specific products but Cosmax received the certification for its manufacturing facilities, allowing it to export an array of products to the U.S.

With the certification, Cosmax will be able to target the U.S. market of sun protection products worth about $800 million a year. “With the FDA certification, we are given a stronghold to export our products to not only the U.S. but also other advanced countries,” said Cosmax Chairman Lee Kyung-soo.

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