D-1251-2020 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- April 29, 2020
- Initiation Date
- March 3, 2020
- Termination Date
- February 6, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12,983 tubes
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.
Reason for Recall
Superpotent drug: This lot of SPF containing lip balm contains up to 150% of the label claim for active ingredient Oxybenzone.
Distribution Pattern
Nationwide within the United States
Code Information
Lot #: 14381, Exp. Date 9/2023