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
D-1566-2019
Product summary
- Event
- Event 82857
- Status
- Terminated
- Classification
- Class II
- Quantity
- 83,050 packets
- Official record key
drug-enforcement:D-1566-2019
Official wording
Reason: 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.
Code information: All lots beginning with 453091
Distribution pattern: Firm's website sales and www.Amazon.com
Derived failure modes
-
Unknown
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.