Agency classClass IIIOur severity:Low FDA (Drugs)·D-1097-2017·Announced 2017-08-23

Linde Eckstein Recalls Beautipharm Moisturizing Balm Due to SPF Labeling Concerns

Linde Eckstein is recalling 478 bottles of Beautipharm All Day Moisturizing Balm SPF 10 because the SPF 10 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 as a Class III recall, 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 478 bottles of Beautipharm All Day Moisturizing Balm SPF 10. The product is a 50 ml facial cream manufactured in Germany and distributed throughout the United States. The recall involves specific lot numbers with expiration dates ranging from August 2017 to January 2019.

The recall was initiated because the product is 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. The FDA has classified this recall as Class III, which indicates that use of or exposure to the product is not likely to cause adverse health consequences.

Consumers who have this product should stop using it and return it to the place of purchase for a refund or follow instructions from the manufacturer. The affected product is identified by the UPC 4 035219 032005 and specific lot numbers listed in the recall notice.

The recalled product

Product: Beautipharm All Day Moisturizing Balm SPF 10 (Octocrylene 4% and Octyl methoxycinnamide 4%) Facial Cream, 1.66 oz. Net. Wt. 50 ml bottle, Art. 03120 Made in Germany, Doctor Eckstein, Linde Eckstein GMBH Co. Kg, 90522 Oberasbach, Germany. UPC 4 035219 032005.
Manufacturer: Linde Eckstein Gmbh + Co KG
Category: Drug — Topical Sunscreen
Hazard: mis-labeling
Affected units: 478

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 (14)

Lot #: 240817
Exp 08/24/17
061217
Exp 12/06/17
290318
Exp 03/29/18
160818
Exp 08/16/18
231118
Exp 11/23/18
160119
Exp 01/16/19
080819
Exp 08/08/19

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