FDA recall D-1566-2019

La Fresh Group, Inc. · Class II · drug

Product

LA FRESH travel lite Sunnyside Lotion Wipe silky, non-greasy formula smooth, soft & moisturizing featuring titanium dioxide, 1 wipe individually wrapped packet, 4.75" x 5.75" (12.0 cm x 14.6 cm) Ingredients: Water, Dimethicone, Dimethiconol, Titanium Dioxide, Benzophenone-3, Octinoxate, Ethylhexylglycerine, Phenoxyethanol, Distributed by La Fresh Group, Inc. Chino, CA 91710 www.LaFreshGroup.com

Reason for recall

Marketed without an Approved NDA/ANDA: The product may be construed a sunscreen due to labeling of the product and comments about the product found on e-commerce websites.

Distribution

Firm's website sales and www.Amazon.com

Key facts

Status
Terminated
Initiation date
2019-07-15
Report date
2019-07-31
Termination date
2021-04-09
Voluntary/Mandated
Voluntary: Firm initiated
Location
Chino, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1566-2019