FDA recall D-1310-2020

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.

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.

Distribution

Nationwide within the US.

Key facts

Status

Terminated

Initiation date

2020-05-15

Report date

2020-06-24

Termination date

2020-09-28

Voluntary/Mandated

Voluntary: Firm initiated

Location

Marion, IA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1310-2020