Agency classClass IIIOur severity:Low FDA (Drugs)·D-1102-2017·Announced 2017-08-23

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

Linde Eckstein is recalling specific lots of SPF 10 liquid make-up because the sun protection factor 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 recall is classified as FDA 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 sand (Titanium Dioxide) SPF 10 liquid make-up. The product is a 1 oz (30 ml) bottle manufactured in Germany and distributed throughout the United States.

The recall is issued because the products are labeled as having SPF 10 protection, but the manufacturer states that this claim cannot be 100% guaranteed. This is classified as a subpotent drug issue.

Consumers with the affected product should check their bottles for the following lot numbers and expiration dates: Lot 300817 (Exp 08/30/2017), Lot 291217 (Exp 12/29/2017), and Lot 010918 (Exp 09/01/2018). The product UPC is 4 035219 032203.

The recalled product

Product: Make Up Transparent sand (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt. 30 ml bottle, Art. 03220, Made in Germany, Doctor Eckstein, Linde Eckstein GMBH Co. Kg, 90522 Oberasbach, Germany, UPC 4 035219 032203.
Manufacturer: Linde Eckstein Gmbh + Co KG
Category: Drug — Topical Sunscreen
Hazard: subpotent-drug
mis-labeling

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 (6)

Lot #: 300817
Exp 08/30/2017
291217
Exp 12/29/2017
010918
Exp 09/01/2018.

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 →

Same manufacturer · Linde Eckstein Gmbh + Co KG

See all →

Low
Linde Eckstein Recalls Make Up Perfect SPF 10 Liquid Make-up
FDA (Drugs) · 2017-08-23
Low
Linde Eckstein Recalls Beautipharm Eye Care Balm Due to SPF Labeling Concerns
FDA (Drugs) · 2017-08-23
Low
Linde Eckstein Recalls Beautipharm Body Moisturizing Balm Due to Subpotent SPF
FDA (Drugs) · 2017-08-23
Low
Linde Eckstein SPF 10 Liquid Make-up Recalled for Subpotent Drug Claim
FDA (Drugs) · 2017-08-23
Low
Linde Eckstein SPF 10 Liquid Make-up Recalled for Subpotent Sun Protection
FDA (Drugs) · 2017-08-23

Same hazard · subpotent drug