Identification of prohibited skin lightening ingredients in misbranded cosmetics products .


Marian Twohig1*, Jane A. Cooper2, Chris Stumpf1
*Corresponding author
1. Waters Corporation, USA 
2. Waters Corporation, United Kingdom


Skin lightening cosmetics products are commonly used to lighten the complexion. There are several skin lightening agents that are routinely used in cosmetics products. However, pharmaceutical active ingredients such as corticosteroids and tretinoin are prohibited for use in cosmetics as skin lightening agents due to the potential side effects (1,2). Hydroquinone is also prohibited in the EU and several other countries (2). In this study, skin lightening products were obtained from online vendors to assess their composition for prohibited active ingredients. The samples were extracted and analysed using UHPLC with Photodiode Array (PDA) and mass detection. This article describes how several samples analysed were found to contain prohibited skin lightening agents and were therefore misbranded as cosmetics products


The practice of lightening skin has a long history and is still practiced today (1). There are many skin lightening/whitening products available on the market. They are often used to produce a more even skin tone (2-4). Several skin lightening agents are allowed for use in cosmetics products including nicotinamide, arbutin and salicylic acid. The products may be marketed to consumers as either a cosmetic to improve appearance of the skin or as a therapy to treat skin conditions (i.e., a drug). The distinction between cosmetic and drug is important from a regulatory and safety perspective because, among other things, a cosmetic should not contain pharmaceutical active ingredients (AI) or otherwise they are classified as a drug according to European Commission’s No. 1223/2009 and the US FDA’s regulations on Cosmetics (5, 6). In this study, we investigate skin lightening products that use AI such as hydroquinone, corticosteroids and tretinoin despite being marketed as cosmetic products.  

The safe use of cosmetics products is of great importance to the cosmetics industry and consumers. The use of the corticosteroid ingredients is prohibited ...