Why it was recalled
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.
Product description
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
Lot numbers, UPCs & expiration codes
All lots beginning with 453091
Where it was sold
Firm's website sales and www.Amazon.com
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-1566-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 15, 2019
- FDA report date
- Jul 31, 2019
- Quantity
- 83,050 packets
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- La Fresh Group, Inc.
Original FDA data
Every field from FDA enforcement report D-1566-2019, exactly as published.
Show all FDA fields
- City
- Chino
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 82857
- Address
- 4651 Schaefer Ave
- Code information
- All lots beginning with 453091
- Postal code
- 91710-5542
- Report date
- Jul 31, 2019
- Product type
- Drugs
- Recall number
- D-1566-2019
- Classification
- Class II
- Recalling firm
- La Fresh Group, Inc.
- Product quantity
- 83,050 packets
- Termination date
- Apr 9, 2021
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Firm's website sales and www.Amazon.com
- Recall initiation date
- Jul 15, 2019
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Jul 31, 2019