In the case of a reaction or problem with a cosmetic product, the first step is to stop using the product and contact your healthcare provider. FDA does not provide medical advice. Then, report the problem to FDA.
Tell FDA If You Experience
- A reaction after using a cosmetic, such as a rash, redness, burn, hair loss, headache, infection, illness or any other unexpected reaction, whether or not it required medical treatment.
- A problem with a cosmetic product, such as a bad smell, color change, other sign of contamination, or foreign material in the product.
Types of Products that are Considered Cosmetics
Cosmetics products are not the same as drug products, and they are regulated differently by FDA. Here are some examples of cosmetic products:
- Tattoos and permanent makeup
- Face and body cleansers, moisturizers and other skin lotions and creams
- Deodorants and makeup
- Baby lotions and oils
- Hair care products, dyes, conditioners, straighteners/relaxers, perms
- Hair removal creams
- Nail polishes
- Shaving products
- Perfumes and colognes
- Face paints and temporary tattoos
How to Report a Problem with Cosmetics
If you are a consumer, health professional, attorney, or member of the cosmetics industry who wants to report a complaint or adverse event (such as an illness, allergic reaction, rash, irritation, scarring, or hair loss) related to a cosmetic, you have three choices:
- Call an FDA Consumer Complaint Coordinator if you wish to speak directly to a person about your problem.
- Complete an electronic Voluntary MedWatch form online.
- Complete a paper Voluntary MedWatch form that can be mailed to FDA.
The law does not require cosmetic companies to report problems to FDA. Therefore, your report is very important in order to help keep the cosmetics market safe. When you contact FDA, you are asked to include the following information in your report, if known:
- About the Person Affected
- Name and contact information (address, phone, and e-mail address)
- Age, gender, and ethnicity
- About the Product
- Name of the product and the manufacturer
- Product codes or identifying marks on the label or container [Note: do not discard the product packaging and labeling. They provide information that will help FDA investigate the problem]
- When and where the product was purchased
- About the Problem
- Description of the reaction or problem
- Description of medical treatment provided, if any
What FDA Will Do with Your Report
Once a report is received:
- FDA will keep your identity confidential.
- FDA will add the report to our database so that we can see if other people are reporting the same problem.
- FDA will use the information to determine if the product or similar products have a history of problems and represent a public health concern that needs to be addressed.
FDA may not take action on every report received, but the Agency does check all reports to determine if action is necessary to protect the public health.
The CFSAN Adverse Event Reporting System (CAERS) Database is a database that contains information on adverse event and product complaint reports submitted to FDA for foods, dietary supplements, and cosmetics. The database is designed to support CFSAN's safety surveillance program. FDA provides raw data extracted from the CAERS database. The data files, which are available in ASCII format, include:
- demographic and administrative information and the CAERS report ID number;
- product information from the case reports;
- symptom information from the reports;
- patient outcome information from the reports.