Agency classClass IIIOur severity:Low FDA (Drugs)·D-1110-2017·Announced 2017-08-23

Linde Eckstein Recalls SPF 10 Liquid Make-Up Due to Subpotent Labeling

Linde Eckstein is recalling Make Up Perfect terra 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. The issue is a labeling guarantee rather than a confirmed contamination or defect.

Plain-English summary

Linde Eckstein Gmbh + Co KG is recalling Make Up Perfect terra (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. bottles. The product is identified by Article number 03350 and UPC 4 035219 033507. The recall involves specific lots: 221217 (expiring 12/22/2017) and 270718 (expiring 07/27/2018).

The recall was initiated because the product is labeled as providing SPF 10 protection, but the manufacturer states that this claim cannot be 100% guaranteed. This is classified as a subpotent drug issue.

The affected product was distributed throughout the United States. Consumers should check their inventory for the specific lot numbers and expiration dates listed above. If they possess the recalled product, they should stop using it and follow the instructions provided by the recalling firm.

The recalled product

Product: Make Up Perfect terra (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt. 30 ml bottle, Art. 03350, Made in Germany, Doctor Eckstein, Linde Eckstein GMBH Co. Kg, 90522 Oberasbach, Germany, UPC 4 035219 033507.
Manufacturer: Linde Eckstein Gmbh + Co KG
Category: Drug — Cosmetic / Sunscreen
Hazard: 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 (4)

Lot #: 221217
Exp 12/22/2017
270718
Exp 07/27/2018.

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 · mis labeling