The Recall Desk
ModerateFDA (Drugs)·D-1566-2019·Announced 2019-07-31

La Fresh Sunnyside Lotion Wipes Recalled for Lack of Approval

La Fresh Group is recalling 83,050 packets of Sunnyside Lotion Wipes because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The hazard is regulatory (lack of approval) rather than a confirmed physical or chemical contamination.

Plain-English summary

La Fresh Group, Inc. is recalling 83,050 packets of LA FRESH travel lite Sunnyside Lotion Wipes. The product is a 1-wipe individually wrapped packet containing ingredients such as Water, Dimethicone, Titanium Dioxide, and Benzophenone-3. The recall affects all lots beginning with 453091.

The recall was initiated because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). The FDA notes that the product may be construed as a sunscreen due to its labeling and comments found on e-commerce websites. The affected units were distributed through the firm's website and Amazon.com.

Consumers who purchased these wipes should stop using them and return them to the place of purchase for a refund or contact the recalling firm for further instructions.

The recalled product

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, Octi
Affected units
83,050

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All lots beginning with 453091

Distribution

Distribution scope not specified by the agency.