Under the recent FDA stated CARES act Hydroquinone is not considered as GRAS and has also been classified as Drug Category II
(For more information, visit the website at: https://www.jdsupra.com/legalnews/congress-enacts-otc-monograph-reform-96907/ )
Sytheon introduced Synovea® HR (INCI: Hexylresorcinol) as a safer and efficacious alternative to Hydroquinone in 2006. Synovea® HR is the optimal tool for addressing hyperpigmentation and globally approved. HR’s performance is superior to hydroquinone: reducing melanogenesis in primary human melanocytes, murine melanoma cells, and pigmented human epidermal equivalents. Several independent clinical studies have deemed Synovea® HR as the gold standard in skin brightening and even toning products demonstrating an efficacy of 2 to 4 times that of hydroquinone. Synovea® HR is effective on all skin types in addressing different types of pigmentation concerns. Hexylresorcinol itself has a long history of human use, well over 80 years, in a number of therapeutic and non-therapeutic applications, with more than 14 years in topical applications. Hexylresorcinol enjoys the GRAS designation and is being used in the food industry for, among other applications, shrimp preservation, and in the personal care industry as an antiseptic in, among other products, throat lozenges and wound cleansers. Recently, HR has been incorporated into several kinds of biomaterials for tissue healing and regeneration thereby strengthening the safety profile of the product. Stay tuned for a clinical study update on “Split-body comparison between Hydroquinone and Hexylresorcinol”
For more information, please send your inquiry to info@sytheonltd.com