Why it was recalled
Superpotent drug: This lot of SPF containing lip balm contains up to 150% of the label claim for active ingredient Oxybenzone.
Product description
PEPPERMINT LIP MOISTURIZER (oxybenzone (4%) and Octinoxate (7%) SPF 15, 4.2 g tube, labeled as a) Bimark Inc., bimark.com; b) NOCO TRAIL REPORT, www.NoCoTrailReport.org; c) Herbruck's, d) St. Mark's Outpatient Surgery Center, 1250 East 3900 South Suite 100, Salt Lake City, UT 84124, e) Trust Company Oklahoma, trustok.com, f) Creekside Dental, www.creeksidedentalkennewick.com, g) Children's Healthcare of Atlanta Hughes Spalding, h) Great Smiles Orthodontics, Dr. Savage & Dr. Weissman, Crestline. Inverness.Turssville, www.bracebygreatsmiles.com, i) Acceleration station, j) The Children's Therapy & Learning Center, www.childrenstlc.com. FLAVORED LIP MOISTURIZER (oxybenzone (4%) and Octinoxate (7%) SPF 15, 4.2 g tube labeled as a) Gregory P. Miller DDS FAGD, 1140 South Avenue North Mankato, MN 56003, www.gregmillerdds.com, b) Shelby, c) Carolina Custom Traders, Wake Forest, North Carolina, c) Palm Springs Dental Associates Jonathan W. Preble, DMD, 499 E. Central Parkway, Suite 200, Altamonte Springs, FL 32701, www.drjpreble.com. LIP MOISTURIZER (oxybenzone (4%) and Octinoxate (7%) SPF 15, 4.2 g tube labeled as Family Dental of Thronton, 12889 Quebec St, Thornton, CO 80602, www.FamilyDentalofThornton.com.
Lot numbers, UPCs & expiration codes
Lot #: 14381, Exp. Date 9/2023
Where it was sold
Nationwide within the United States
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-1251-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 3, 2020
- FDA report date
- Apr 29, 2020
- Quantity
- 12,983 tubes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Yusef Manufacturing Laboratories, LLC
Original FDA data
Every field from FDA enforcement report D-1251-2020, exactly as published.
Show all FDA fields
- City
- Clearfield
- State
- UT
- Status
- Terminated
- Country
- United States
- Event ID
- 85323
- Address
- Freeport West, F-4, #3
- Code information
- Lot #: 14381, Exp. Date 9/2023
- Postal code
- 84016
- Report date
- Apr 29, 2020
- Product type
- Drugs
- Recall number
- D-1251-2020
- Classification
- Class II
- Recalling firm
- Yusef Manufacturing Laboratories, LLC
- Product quantity
- 12,983 tubes
- Termination date
- Feb 6, 2024
- Reason for recall
- Superpotent drug: This lot of SPF containing lip balm contains up to 150% of the label claim for active ingredient Oxybenzone.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- PEPPERMINT LIP MOISTURIZER (oxybenzone (4%) and Octinoxate (7%) SPF 15, 4.2 g tube, labeled as a) Bimark Inc., bimark.com; b) NOCO TRAIL REPORT, www.NoCoTrailReport.org; c) Herbruck's, d) St. Mark's Outpatient Surgery Center, 1250 East 3900 South Suite 100, Salt Lake City, UT 84124, e) Trust Company Oklahoma, trustok.com, f) Creekside Dental, www.creeksidedentalkennewick.com, g) Children's Healthcare of Atlanta Hughes Spalding, h) Great Smiles Orthodontics, Dr. Savage & Dr. Weissman, Crestline. Inverness.Turssville, www.bracebygreatsmiles.com, i) Acceleration station, j) The Children's Therapy & Learning Center, www.childrenstlc.com. FLAVORED LIP MOISTURIZER (oxybenzone (4%) and Octinoxate (7%) SPF 15, 4.2 g tube labeled as a) Gregory P. Miller DDS FAGD, 1140 South Avenue North Mankato, MN 56003, www.gregmillerdds.com, b) Shelby, c) Carolina Custom Traders, Wake Forest, North Carolina, c) Palm Springs Dental Associates Jonathan W. Preble, DMD, 499 E. Central Parkway, Suite 200, Altamonte Springs, FL 32701, www.drjpreble.com. LIP MOISTURIZER (oxybenzone (4%) and Octinoxate (7%) SPF 15, 4.2 g tube labeled as Family Dental of Thronton, 12889 Quebec St, Thornton, CO 80602, www.FamilyDentalofThornton.com.
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Mar 3, 2020
- Initial firm notification
- Center classification date
- Apr 22, 2020