Information About The Safety of the Skin Lightener Hydroquinone

Hydroquinone is one of the most effective and commonly used skin lighteners and is available in both over-the-counter and prescription formulations. The FDA recently proposed a ban on hydroquinone due to studies linking hydroquinone to the development of cancers in animals and the rare development of a darkening of the skin called exogenous ochronosis.

In response to the proposed ban, many dermatologists disagreed with the FDA for a variety of reasons. They felt that the studies linking hydroquinone to cancer were faulty because they involved feeding laboratory animals with large quantities of hydroquinone. In practice, hydroquinone is applied to the skin and NOT eaten. Therefore, it was felt that these studies were not relevant to the use of hydroquinone for dermatologic conditions. In addition, people are exposed on a daily basis to hydroquinones from food items such as pears, coffee and tea at much higher doses than the doses used topically. Studies of cancer rates in workers who are exposed to high occupational levels of hydroquinone, such as in the photographic industry, demonstrate that these workers have similar if not lower rates of cancer than the general population.

While the concern about exogenous ochronosis is understandable, dermatologists believe that they may be overhyped. There have been less than 10 documented cases of exogenous ochronosis in the United States over the last 40 years. The condition seems to occur most commonly in Africa and may be caused by an environmental contribution . In addition, exogenous ochronosis is more common when hydroquinone is used to make the skin lighter than it is supposed to be. In the United States, it is used to restore abnormally darkened skin to its normal color, at which point the hydroquinone is discontinued. For more detailed information, please see:

The safety of hydroquinone: A dermatologist’s response to the 2006 Federal Register, 28 April 2007 Jacob Levitt Journal of the American Academy of Dermatology November 2007 (Vol. 57, Issue 5, Pages 854-872).

At Keris, we understand your concerns about hydroquinone. While we confidently recommend our own hydroquinone formulations, which are high-quality prescription strength compounds that are custom formulated and maintain potency, unlike other hydroquinone agents, we also provide a variety of alternative skin lightening agents. While these agents are not as efficacious as hydroquinone, they include Kojic acid, arbutin, licorice and mulberry extracts among others. Our favorite alternative skin lightener is Azelac RU Serum.

Download the The Safety of Hydroquinone (PDF)