Why it was recalled
Labeling: Label mix-up
Product description
Coppertone Kids Sunscreen Spray (avobenzone 3%, Homosalate 10%, Octisalate 5%, Octocrylene 4%, Oxybenzone 5%) 8.3 oz. bottle, Dist. by: Bayer Healthcare LLC Whippany, NJ 07981, UPC 41100573636.
Lot numbers, UPCs & expiration codes
Lot#: 7N04CS, 7N05CS, Exp. 11/2019
Where it was sold
Arkansas only
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0590-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 23, 2018
- FDA report date
- Mar 14, 2018
- Quantity
- 528 units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Bayer HealthCare Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-0590-2018, exactly as published.
Show all FDA fields
- City
- Whippany
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 79252
- Address
- 100 Bayer Blvd
- Code information
- Lot#: 7N04CS, 7N05CS, Exp. 11/2019
- Postal code
- 07981-1544
- Report date
- Mar 14, 2018
- Product type
- Drugs
- Recall number
- D-0590-2018
- Classification
- Class II
- Recalling firm
- Bayer HealthCare Pharmaceuticals, Inc.
- Product quantity
- 528 units
- Termination date
- Jan 9, 2020
- Reason for recall
- Labeling: Label mix-up
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Coppertone Kids Sunscreen Spray (avobenzone 3%, Homosalate 10%, Octisalate 5%, Octocrylene 4%, Oxybenzone 5%) 8.3 oz. bottle, Dist. by: Bayer Healthcare LLC Whippany, NJ 07981, UPC 41100573636.
- Distribution pattern
- Arkansas only
- Recall initiation date
- Feb 23, 2018
- Initial firm notification
- Letter
- Center classification date
- Mar 12, 2018