The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-1104-2017·Announced 2017-08-23

Linde Eckstein SPF 10 Liquid Make-up Recalled for Subpotent Drug Concerns

Linde Eckstein is recalling specific lots of SPF 10 liquid make-up because the sun protection claim cannot be fully guaranteed.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The FDA classified this recall as Class III, which by definition is unlikely to cause adverse health consequences, fitting the 'Low' severity criteria for minor labeling or documentation issues.

Plain-English summary

Linde Eckstein Gmbh + Co KG is recalling specific lots of Make Up Transparent dark tan (Titanium Dioxide) SPF 10 liquid make-up. The product is a 1 oz (30 ml) bottle manufactured in Germany. The affected lots are 040318 (Exp 03/04/2018) and 261018 (Exp 10/26/2018). The product was distributed throughout the United States.

The recall is due to the product being classified as a subpotent drug. The products are labeled as having SPF 10 protection; however, the source text states that this claim cannot be 100% guaranteed. The FDA has classified this recall as Class III.

Consumers with the affected product should stop using it and contact the recalling firm for further instructions.

The recalled product

Product
Make Up Transparent dark tan (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt. 30 ml bottle, Art. 03240, Made in Germany, Doctor Eckstein, Linde Eckstein GMBH Co. Kg, 90522 Oberasbach, Germany, UPC 4 035219 032401.
Manufacturer
Linde Eckstein Gmbh + Co KG
Category
Drug — Topical Sunscreen
Hazard

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 (4)

  • Lot #: 040318
  • Exp 03/04/2018
  • 261018
  • Exp 10/26/2018.

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 14 recalled by Linde Eckstein Gmbh + Co KG under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 14 products in this recall →

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