Mar 29 2022
Cosmetic products (such as soaps, lotions, face and eye make up, fragrances, etc.) can provoke allergic reactions in some people. Allergic reactions are the immune system’s overreaction to substances that may otherwise be harmless. An allergen can trigger the immune system to release chemical substances such as antibodies that result in allergy symptoms. Allergic reactions to cosmetics most often appear as itchy, red rashes on the skin – or contact dermatitis.
Common Allergens Found in Cosmetic Products
The FDA has compiled the list below of common allergens found in some cosmetic products. These are allergens that cause most allergic reactions from the use of cosmetic products.
Common allergens fall into the five classes as detailed below: natural rubber, fragrances, preservatives, dyes, and metals.
As noted below, these specific ingredients may not be identified on the cosmetic product label. The European Commission, which has conducted extensive research on fragrance allergens, lists the following 26 fragrance ingredients listed as allergens in Annex III of the European Union Cosmetics DirectiveExternal Link Disclaimer:
Hydroxyisohexyl 3-cyclohexene carboxaldehyde (HICC), (also known as Lyral)
Oak moss extract
Tree moss extract
MethylisothiazolinoneExternal Link Disclaimer (MIT)
Formaldehyde and formaldehyde releasing ingredients:
DMDM hydantoin (1,3-dimethylol-5,5-dimethylhydantoin)
Quaternium-15 (Dowicil 200; N-(3-chloroallyl) hexaminium chloride)
The FDA is also taking steps to learn more about consumer practices and use of cosmetics.
In addition, the FDA intends to conduct interviews with the cosmetics industry to understand how manufacturing, marketing, and sale of cosmetic products is impacted by information on allergic reactions to cosmetic products.
Through interviews with state and local regulatory authorities, FDA will continue to focus on awareness of safety issues associated with cosmetic ingredients, including potential allergens, and how to monitor and address these issues.
FDA can and does inspect cosmetic manufacturing facilities to assure
cosmetic product safety and determine whether cosmetics are adulterated
or misbranded under the FD&C Act or FPLA.
If you have any questions about FDA regulation of OTC Drugs and Cosmetics,
Registration and labeling compliance... , please CONTACT US.