CTK Accelerates U.S. Market Expansion with Launch of Three FDA OTC–Compliant White-Label Suncare Products

CORONA, CA, UNITED STATES, January 20, 2026 /EINPresswire.com/ -- CTK, a global beauty platform company, is accelerating its expansion into the U.S. market with the launch of three white-label suncare products developed in compliance with the U.S. Food and Drug Administration (FDA)’s Over-the-Counter (OTC) requirements, marking a significant step in growing its North American beauty business.

CTK recently completed FDA OTC registration and related compliance steps for three white-label suncare products: a sun lotion, sun stick, and sun serum. “OTC” refers to drug products that can be purchased without a prescription. In the United States, certain products such as sunscreens, acne treatments, and hair loss treatments are regulated as drugs rather than cosmetics and therefore must comply with FDA OTC regulations.

Accordingly, meeting FDA OTC requirements, including establishment registration, product listing, and compliance with applicable OTC monographs, is essential to market OTC products in the U.S. By leveraging pre-established, FDA OTC-compliant white-label products, brands can launch in the U.S. market in as little as four months, without having to independently navigate complex regulatory pathways from scratch. For brands considering entry into the U.S. market, proactively securing OTC compliance, as CTK has done, can represent a practical and efficient solution.

The three newly launched OTC white-label suncare products are developed in compliance with FDA OTC regulations related to UV protection performance and safety, meeting applicable U.S. standards for sunscreen products. All three products provide SPF 50 broad-spectrum protection and feature lightweight, silky textures inspired by Korean skincare, enabling smooth application and quick absorption while maintaining high performance. The formulas are developed using clean, naturally derived ingredients and incorporate K-beauty-inspired benefits such as hydration and anti-aging, delivering both functional performance and a refined sensory experience.

CTK’s OTC products are manufactured at CTK OTC Laboratories in California, USA. The facility operates under stringent quality control systems and FDA regulatory compliance standards. In addition to sunscreens, CTK maintains a broad portfolio of FDA-compliant OTC manufacturing capabilities, including acne treatments, skin protectants, and hand sanitizers, with plans to further expand its product lineup.

A CTK representative stated, “CTK OTC Laboratories has already established the regulatory and quality infrastructure required to support FDA OTC manufacturing. This enables brands to enter the U.S. OTC market in a faster, safer, and more efficient way—without the burden of navigating regulatory complexity on their own.”

The representative added, “By combining K-beauty formulation expertise with U.S.-based manufacturing and compliance capabilities, CTK’s white-label solutions are designed to help global beauty brands unlock new opportunities in the U.S. market.”

Additionally, CTK OTC Laboratories, LLC, located in Corona, California, supports global brands’ entry into the U.S. OTC market by offering a sustainable and clean manufacturing environment, customized formulation development, and comprehensive regulatory compliance support.

Get started at https://ctkclip.com/

For more details contact CTK Co., Ltd. Corporate Strategy Team:
Hyuh Ahn, Head of Division: harryan@ctkclip.com
Kyuri Kim, Manager: kyurikim@ctkclip.com

Websites:
https://www.ctkcosmetics.com
https://www.ctkotc.com/

Address :
CTK : 234, Hyoryeong-ro, Seocho-gu, Seoul, Republic of Korea.
CTK OTC LABORATORIES: 1690 N Delilah St, Corona, California 92879, USA.

Kyuri Kim (Group Strategy Team)
CTK Co., Ltd.
kyurikim@ctkclip.com

Legal Disclaimer:

EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.