Labeling Laws for Personal Care Products: Potential Pitfalls for the Consumer

Evelyne Tantry; Ariadna Perez-Sanchez, MD; Shelly Fu; Shravya Potula; Rajani Katta, MD


Skin Therapy Letter. 2021;26(5):1-6. 

In This Article

Skin and Hair Care Products

Potential pitfalls for consumers when evaluating skin and hair care product labels can be categorized into three broad categories. These include the potential for confusion with marketing terms, labels that are incomplete, and labels that may be misinterpreted.

Marketing Terms

As many labeling terms lack FDA definitions, they can essentially mean anything a manufacturer decides. The term "hypoallergenic", for example, is not regulated by law. Therefore, although the term is commonly used in marketing a product, it does not inform consumers about the actual safety of a product.

Similarly, there are no legal standards for qualifying a product as a "baby product." This may lead to consumer concerns about certain ingredients, as in 2013 when Johnson & Johnson was pressured by consumers to remove formaldehyde and 1,4-dioxane from about 100 of its baby products.[5] According to the NACDG, formaldehyde is the fourth most common allergen in cosmetics.[2]

One study evaluated the use of marketing terms on products. Researchers found that out of 187 cosmetic products, 89% "contained at least 1 contact allergen, 63% 2 or more, and 11% 5 or more" despite being marketed as "hypoallergenic", "dermatologist recommended/tested", "fragrance free", or "paraben free."[6]

The lack of regulation involving personal care products marketed and sold as "hypoallergenic", "baby product", "natural," "for sensitive skin", and other terms is further discussed in Table 3.

Incomplete Labels

"Free of" Labels. The growing trend among consumers to purchase "free of " ingredient cosmetics, as evident by growing sales and market shares of these products, has prompted cosmetic companies to address these factors when marketing their products.[7]

While these labels are technically correct, they often do not highlight information that patients would find useful. For example, the words "paraben-free" are often highlighted on product labels. However, for those who are prone to ACD, the words "free of methylisothiazolinone" (MI) would be more useful. The NACDG publishes a Significance-Prevalence Index Number (SPIN) ranking, which is a weighted calculation that incorporates both clinical relevance and prevalence of an allergen.[2] MI had the highest SPIN rating of all allergens tested. It has been banned by the European Commission from use in leave-on products, although it is still used in the US. By contrast, parabens were ranked 48th and had the lowest prevalence of positivity of any major preservative on the North American market. In 2019, the American Contact Dermatitis Society announced that because "[parabens] are rarely problematic as contact allergens, [parabens] have been designated (non) allergen of the year."[8]

"Active" Ingredients Listed Separately From Inactive Ingredients. For consumers with ACD, knowledge of all ingredients found in a product is critical. Thus, consumers must be aware that certain product categories separate active ingredients from inactive ingredients. Consumers choosing sunscreens, eyedrops, and over-the-counter medications must be informed to seek out information on both active and inactive ingredients, as sections are separated in these product categories.

Labels That may be Misinterpreted

Fragrance additives are one of the top causes of ACD,[2] but avoidance can be challenging for patients. While product labels may use the terms "fragrance-free" and "unscented", these terms are frequently misinterpreted by consumers.

  • Although the term "fragrance-free" might suggest that a product does not contain any fragrance additives, that is not correct. The FDA defines fragrance as "any natural or synthetic substance or substances used solely to impart an odor to a cosmetic product." According to that definition, if a fragrance additive is used for another function, then it may legally be included in a fragrance-free product.[9] Examples are benzyl alcohol, which may be used as a preservative, and rose oil, which may be used as a moisturizing ingredient.

  • Unscented products may contain masking fragrances.