Cosmax Establishes Dedicated Team for Sunscreen Products

Targeting the $3 Trillion US Sun Care Market

Cosmax, a cosmetics research, development, and manufacturing (ODM) company, has established a dedicated organization for ultraviolet (UV) protection functional OTC (Over-the-Counter) products within its domestic research center. The company plans to actively respond to the rapidly increasing demand for entry into the U.S. market by strengthening its expertise in sun care products, which are classified as pharmaceuticals in the United States.

Introduction to Cosmax R&I Center OTC Lab.
[Photo by Cosmax]

Cosmax announced on the 12th that it has established an OTC dedicated organization called the ‘OTC Lab’ within its R&I (Research & Innovation) Center.

Cosmax has obtained approval from the U.S. FDA (Food and Drug Administration) and produces OTC sun care products at two locations: its Hwaseong plant in Gyeonggi Province and its New Jersey plant in the United States.

UV protection products, classified as functional cosmetics in Korea, are categorized as pharmaceutical OTC items in the U.S. and are subject to pharmaceutical-level management and control by the FDA. Representative OTC items include sunscreens, acne products, and anti-dandruff shampoos.

According to Cosmax, FDA registration is required for all facilities that manufacture, repackage, or relabel pharmaceuticals used in the U.S. Unlike in Korea, sunscreen manufacturing sites are inspected under pharmaceutical standards rather than cosmetic standards, applying stringent criteria.

Since becoming the first in the industry to obtain U.S. FDA OTC certification in 2016, Cosmax has maintained this certification through rigorous quality control. The company has also established a specialized OTC product management system capable of responding in real time to changing U.S. FDA regulations through its global quality team within the R&I Center.

Based on the accumulated know-how, Cosmax plans to actively support its clients from the early stages of entering the U.S. OTC sun care market and will continuously expand the formulations and product lineup of sunscreens that can be produced as OTC items.

Meanwhile, according to Euromonitor, the global sun care market size in 2023 is approximately $12.4 billion (about 16 trillion KRW). Among this, the U.S. sun care market size is about $2.6 billion (about 3.3 trillion KRW), accounting for more than 20% of the total market share.

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