Why it was recalled
Mislabeling: The active ingredient list on the label does not match the product's actual ingredients Specifically, the label states Octinoxate 7.5% and Oxybenzone 3%, while the product therein is made with Octinoxate 7.5%, Octisalate 5%, Octocrylene 5%, and Avobenzone 3%.
Product description
Higher Education Make Out Ready Vegan Lip Balm, SPF 15, Net Wt. 0.15 oz (4.25 g) per tube, Active Ingredients: Oxtinoxate (7.5%), Oxybenzone (3%); Distributed by: Higher Education Skincare, 1.833.251.0388
Lot numbers, UPCs & expiration codes
Lot 93400-21200
Where it was sold
CA
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-0890-2022
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Apr 29, 2022
- FDA report date
- Jun 1, 2022
- Quantity
- 17,000 units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Eco Lips, Inc
Original FDA data
Every field from FDA enforcement report D-0890-2022, exactly as published.
Show all FDA fields
- City
- Cedar Rapids
- State
- IA
- Status
- Terminated
- Country
- United States
- Event ID
- 90197
- Address
- 6000 Huntington Ct Ne
- Code information
- Lot 93400-21200
- Postal code
- 52402-1268
- Report date
- Jun 1, 2022
- Product type
- Drugs
- Recall number
- D-0890-2022
- Classification
- Class III
- Recalling firm
- Eco Lips, Inc
- Product quantity
- 17,000 units
- Termination date
- Aug 25, 2022
- Reason for recall
- Mislabeling: The active ingredient list on the label does not match the product's actual ingredients Specifically, the label states Octinoxate 7.5% and Oxybenzone 3%, while the product therein is made with Octinoxate 7.5%, Octisalate 5%, Octocrylene 5%, and Avobenzone 3%.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Higher Education Make Out Ready Vegan Lip Balm, SPF 15, Net Wt. 0.15 oz (4.25 g) per tube, Active Ingredients: Oxtinoxate (7.5%), Oxybenzone (3%); Distributed by: Higher Education Skincare, 1.833.251.0388
- Distribution pattern
- CA
- Recall initiation date
- Apr 29, 2022
- Initial firm notification
- Center classification date
- May 23, 2022