May 2020 FDA Recall Drug by Eco Lips Inc
D-1310-2020 - Superpotent Drug

This Class II drug recall was voluntarily initiated by Eco Lips Inc on May 15, 2020 for the product Drug. The FDA reported the reason for recall as superpotent drug. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1310-2020

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.
Initiated
05-15-2020
Reported
06-24-2020
Quantity
68,400 tubes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85774
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Eco Lips Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the US.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-28-2020
Product Description About Product Description
Full technical description of the product.
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.

Batch or Lot Expiration 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.