If you’ve had a bad reaction to a cosmetic product—like a rash, burn, or even hair loss—or noticed something off with a product (bad smell, color change, or contamination), it’s important to take action.

What to Do First

1. Stop using the product immediately.
2. Contact your healthcare provider if you’re experiencing a medical issue.
3. Report the issue to the FDA.

Products Considered “Cosmetics”

Cosmetic products include a wide range of everyday items, such as:

• Makeup (mascara, lipstick)
• Skincare (lotions, cleansers)
• Haircare (dyes, relaxers, conditioners)
• Tattoo ink & permanent makeup
• Deodorants, perfumes, shaving products
• Nail polish, temporary tattoos, and more

How to Report to the FDA

Consumers and health professionals can file a complaint in three ways:

• Submit an online report via the MedWatch Voluntary Reporting Form.
• Fill out a paper form and send it to:
  • MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852
  • Fax: 1-800-332-0178
• Call the FDA’s Food and Cosmetics Information Center at 1-888-SAFEFOOD (1-888-723-3366)

Industry Requirements

Thanks to the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), companies must now report serious adverse events to the FDA within 15 business days. This includes submitting product labeling and any follow-up medical info received within a year.

Reports must be filed using Form FDA 3500A, available through the FDA’s MedWatch site