Why it was recalled
Superpotent Drug: The active ingredient, avobenzone, is used at 5% which is higher than the allowable 3% in the sunscreen formula per FDA sunscreen regulations.
Product description
EcoLips Sport Lip Balm, SPF 30, Avobenzone (5%), Octinoxate (10%), Octisalate (5%), Net Wt. 0.15 oz. (4.25g) tube, Eco Lips, Inc., Marion, IA 52302, UPC: 859623000030; 859623000177; 859623000573; Display UPC: 859623000092; 859623000108; 859623000139; 859623000146; 859623000184; 859623000535; 859623001037.
Lot numbers, UPCs & expiration codes
Lot #s: S-17-157, S-17-163C, Exp. 06/30/2020; S-17-187, S-17-S194, Exp. 07/31/2020; S-17-262, S-17-271, Exp. 09/30/2020; S-17-339, Exp. 12/31/2020; S-18-029, Exp. 01/31/2021; S-18-044, Exp. 02/28/2021; S-18-072, Exp. 03/31/2021; S-18-116, Exp. 04/30/2021; S-18-145, Exp. 05/31/2021; S-18-227, Exp. 08/31/2021; S-18-355, Exp. 12/31/2021; 00003 19081, Exp. 03/31/2022; 00003 19304, Exp. 11/30/2022.
Where it was sold
Nationwide within the US.
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-1310-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 15, 2020
- FDA report date
- Jun 24, 2020
- Quantity
- 68,400 tubes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Eco Lips Inc
Original FDA data
Every field from FDA enforcement report D-1310-2020, exactly as published.
Show all FDA fields
- City
- Marion
- State
- IA
- Status
- Terminated
- Country
- United States
- Event ID
- 85774
- Address
- 1199 44th St
- Code information
- Lot #s: S-17-157, S-17-163C, Exp. 06/30/2020; S-17-187, S-17-S194, Exp. 07/31/2020; S-17-262, S-17-271, Exp. 09/30/2020; S-17-339, Exp. 12/31/2020; S-18-029, Exp. 01/31/2021; S-18-044, Exp. 02/28/2021; S-18-072, Exp. 03/31/2021; S-18-116, Exp. 04/30/2021; S-18-145, Exp. 05/31/2021; S-18-227, Exp. 08/31/2021; S-18-355, Exp. 12/31/2021; 00003 19081, Exp. 03/31/2022; 00003 19304, Exp. 11/30/2022.
- Postal code
- 52302-1545
- Report date
- Jun 24, 2020
- Product type
- Drugs
- Recall number
- D-1310-2020
- Classification
- Class II
- Recalling firm
- Eco Lips Inc
- Product quantity
- 68,400 tubes
- Termination date
- Sep 28, 2020
- Reason for recall
- Superpotent Drug: The active ingredient, avobenzone, is used at 5% which is higher than the allowable 3% in the sunscreen formula per FDA sunscreen regulations.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- EcoLips Sport Lip Balm, SPF 30, Avobenzone (5%), Octinoxate (10%), Octisalate (5%), Net Wt. 0.15 oz. (4.25g) tube, Eco Lips, Inc., Marion, IA 52302, UPC: 859623000030; 859623000177; 859623000573; Display UPC: 859623000092; 859623000108; 859623000139; 859623000146; 859623000184; 859623000535; 859623001037.
- Distribution pattern
- Nationwide within the US.
- Recall initiation date
- May 15, 2020
- Initial firm notification
- Letter
- Center classification date
- Jun 15, 2020