Unigen Announces Approval of UP302 as a Skin-Whitening/Spot Removing Special Functional Cosmetic ingredient by China’s NMPA
TACOMA, WASHINGTON – November 10, 2025: Unigen Inc., a natural product R&D and proprietary ingredient supplier, has received approval from China’s Natural Medical Products Administration (NMPA) for its novel research composition, UP302, as a new cosmetic ingredient for skin-whitening and spot-removal (INCI name: Dimethoxy tolylpropyl resorcinol; Registration Certificate No. Guo Zhuang Yuan Zhu Zi 20250001).
In China, skin-whitening is a medical term requiring approval by China’s NMPA, but is more commonly referred to as skin brightening in Western cosmetic marketing.
This approval holds profound industry significance, according to Unigen’s Chief Scientific Officer, Dr. Qi Jia. “UP302 is only the third skin-whitening and spot removing ingredient approved in China in nearly 30 years. Unigen has built a strong pipeline in this field, with more novel actives in development and in the commercialization pipeline.”
Unigen’s President & Chief Executive Officer, Regan Miles, stated: “This is the first case since the implementation of the Cosmetics Supervision and Administration Regulation (CSAR) where an existing market ingredient (UP302®) has successfully passed re-evaluation for both safety and efficacy and been approved for special cosmetic use. This approval has demonstrated the commitment of Unigen to scientific integrity and clinical evidence for the skin-whitening and spot removing application of UP302. With China NMPA’s approval and Unigen’s strong relationship with Estée Lauder Companies, I am excited for the opportunity to bring innovative products to meet the needs of global consumers.”
UP302 is a new chemical entity discovered by Unigen after screening over 2,200 plant extracts for novel tyrosinase inhibitor. A potent and rather minor compound at ppm level was isolated, purified and identified from a Chinese medicinal plant – Dianella ensifolia. More than a decade of collaboration with Estée Lauder Companies and Clinique to understand the mechanism of action, stability and skin penetration led to publication of UP302’s innovative dual-pathway mechanism, providing full-spectrum pigmentation control:
- Triple Anti-Darkening: inhibits tyrosinase activity at the source, accelerates its degradation, and reduces post-inflammatory hyperpigmentation.
- Double Anti-Yellowing: neutralizes free radical damage via antioxidant action and combats glycation to improve dullness and sallowness.
After conducting deep structural analysis, precise modifications, advanced chemical synthesis and bioengineering, Unigen achieved cGMP-scale production, ensuring UP302 to be produced at highest purity with batch-to-batch consistency.
Unigen was granted formal approval for Dimethoxytolylpropyl Resorcinol (UP302) in 2012 by the US Food and Drug Administration, becoming the first cosmetic new ingredient to receive such distinction. UP302 was first used as a new cosmetic ingredient by Estée Lauder’s Clinique brand in the United States. UP302 has been formulated in Clinique Even Better Clinical Dark Spot Clearing Serum for more than 15 years, used by tens of millions of consumers worldwide, with a good safety profile and high favorability rating among consumers.
In preparing the UP302 submission for China NMPA’s approval, Unigen and Estee Lauder Companies (CHINA) followed the guidelines in China’s Cosmetics Supervision and Administration Regulation. The two companies collaborated closely with their internal teams in formulation, quality control, clinical study and regulatory to compile superior safety, efficacy and clinical evidence on UP302 for China NMPA’s review and ultimate approval.
For further information about UP302 and Unigen Beauty, please contact:
MEDIA INQUIRIES
Kathy Markham
Marketing Manager,
Unigen, Inc.
Email: kmarkham@unigen.net
Website: unigen.net
About Unigen, Inc.
Unigen discovers, develops, and manufactures proprietary natural-product active ingredients for dietary supplements, cosmetic and personal care products, prescription medical food and botanical drug products. The Company discovers its ingredients through its high throughput screening PhytoLogix® approach applied to a proprietary well-annotated collection of botanicals and a legacy mining approach applied to botanicals having known medicinal benefits.
Mechanism of action, safety and efficacy are documented with extensive preclinical in vitro and in vivo testing and by human clinical studies. Unigen protects its discoveries with issued patents and patent filings in all major territories and manufactures its products to GMP standards. Unigen commercializes its proprietary ingredients through licensing and ingredient supply alliances with commercial partners engaged in the manufacture, distribution, and marketing of end-products in each of Unigen’s target markets.