Home > Benzoyl Peroxide Warning


Benzoyl peroxide generates free radicals in the skin. Its effect is similar to unprotected sun exposure. The redness of the skin (erythema), caused by sun exposure and benzoyl peroxide, is the result of free radicals (oxidative stress) upon the skin. Repeated sun exposure or benzoyl peroxide use generates free radicals that damage the skin's structure and cellular DNA, resulting in premature aging of the skin. The extent of the damage and aging from benzoyl peroxide is determined by the concentration of benzoyl peroxide, the frequency of application, and the duration of its use.Because benzoyl peroxide generates free radicals, it interferes with and slows the healing process. The red and brown marks that are a part of the acne healing process may last weeks longer when benzoyl peroxide is a regular part of the daily regimen.Benzoyl peroxide has been linked to cancer for a number of years and many research journal entries state "benzoyl peroxide is a free radical-generating skin tumor promoting agent." Performing a word search of the words "benzoyl peroxide cancer" in PubMed in the National Library of Medicine produces 102 articles from medical publications dealing with research aspects of benzoyl peroxide and cancer. About two-thirds of the research supports linkage between benzoyl peroxide and skin cancer."In 1995 the FDA changed benzoyl peroxide from a Category I (safe) to a Category III (safety is uncertain) ingredient and stated this action (56 FR 37622) was based on new information that raised a safety concern regarding benzoyl peroxide as a tumor promoter in mice ..." Additionally the FDA charged manufacturers with the responsibility of providing this information to consumers so they could make educated decisions. A more complete FDA statement is at the bottom of this page, for your reference.FDA / BENZOYL PEROXIDE ACTION: FEBRUARY 17, 1995*

Food and Drug Administration (FDA) / Department of Health and Human Services

"Topical Drug Products Containing Benzoyl Peroxide: Required Labeling""The Food and Drug Administration (FDA) is proposing additional labeling (warning and directions) for all topically-applied acne treatment drug products containing benzoyl peroxide. The warning advises consumers to avoid unnecessary sun exposure and to use a sunscreen when using a benzoyl peroxide product to treat acne ...""The agency classified benzoyl peroxide from its previous status Category I to Category III status. This action (56 FR 37622) was based on new information that raised a safety concern regarding benzoyl peroxide as a tumor promoter in mice and a study that reported that benzoyl peroxide has tumor initiation potential.""FDA evaluated these data and information and determined that the studies show that benzoyl peroxide is a skin tumor promoter in more than one strain of mice as well as in hamsters. To date, topical studies (which have shown only tumor promotion) have been of short duration (about 52 weeks).Although animal data and human epidemiology data are available, the agency has determined that further studies are necessary to adequately assess the tumorigenic potential of benzoyl peroxide. These studies are currently being conducted.The agency acknowledges that it may take several years for these studies to be completed and analyzed, and for the final determination to be made on benzoyl peroxide's safety."*J Biomed Mater Res A. 2004 Dec 15;71(4):682-92 — J Biochem Mol Toxicol. 2004;18(2):107-14 — 
Indian J Exp Biol. 2003 Aug;41(8):827-31

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