Why it was recalled
Labeling; Product Contains Undeclared API (Oxybenzone)
Product description
Coppertone SUNSCREEN LOTION, CLEARLY SHEER, BROAD SPECTRUM SPF 50, 5 FL OZ (147mL), OTC, Dist by: Bayer HealthCare LLC, Whippany, NJ 07981 --- NDC 11523-7391-1, UPC 00041100005762
Lot numbers, UPCs & expiration codes
CV006V9, 2/2018
Where it was sold
Nationwide
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-0977-2016
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 10, 2016
- FDA report date
- Jun 15, 2016
- Quantity
- 37,512 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Bayer Health Care LLC
Original FDA data
Every field from FDA enforcement report D-0977-2016, exactly as published.
Show all FDA fields
- City
- Cleveland
- State
- TN
- Status
- Terminated
- Country
- United States
- Event ID
- 74138
- Address
- 4207 Michigan Avenue Rd NE
- Code information
- CV006V9, 2/2018
- Postal code
- 37323-5505
- Report date
- Jun 15, 2016
- Product type
- Drugs
- Recall number
- D-0977-2016
- Classification
- Class II
- Recalling firm
- Bayer Health Care LLC
- Product quantity
- 37,512 bottles
- Termination date
- Oct 6, 2016
- Reason for recall
- Labeling; Product Contains Undeclared API (Oxybenzone)
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Coppertone SUNSCREEN LOTION, CLEARLY SHEER, BROAD SPECTRUM SPF 50, 5 FL OZ (147mL), OTC, Dist by: Bayer HealthCare LLC, Whippany, NJ 07981 --- NDC 11523-7391-1, UPC 00041100005762
- Distribution pattern
- Nationwide
- Recall initiation date
- May 10, 2016
- Initial firm notification
- Letter
- Center classification date
- Jun 9, 2016