Agency classClass IIIOur severity:Low FDA (Drugs)·D-1098-2017·Announced 2017-08-23

Linde Eckstein Recalls Beautipharm Body Moisturizing Balm Due to Subpotent SPF

Linde Eckstein is recalling Beautipharm Body Moisturizing Balm SPF 10 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 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 Beautipharm Body Moisturizing Balm SPF 10 (Octocrylene 4% and Octyl methoxycinnamide 4%) Body Lotion. The product is an 8.3 oz (250 ml) bottle manufactured in Germany. The recall involves 105 units of the cream.

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 affected lots are 201017 (Exp 10/20/17), 290618 (Exp 06/29/18), and 040419 (Exp 04/04/19).

The product was distributed throughout the United States. Consumers should check their lot numbers and expiration dates to determine if they have an affected unit. The FDA has classified this as a Class III recall, indicating that the violation is not likely to cause adverse health consequences.

The recalled product

Product: Beautipharm Body Moisturizing Balm SPF 10 (Octocrylene 4% and Octyl methoxycinnamide 4%) Body Lotion, 8.3 oz. Net. Wt. 250 ml bottle, Art. 03150 Made in Germany, Doctor Eckstein, Linde Eckstein GMBH Co. Kg, 90522 Oberasbach, Germany. UPC 4 035219 031503.
Manufacturer: Linde Eckstein Gmbh + Co KG
Category: Drug — Topical Sunscreen
Hazard: mis-labeling
Affected units: 105

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 #: 201017
Exp 10/20/17
290618
Exp 06/29/18
040419
Exp 04/04/19.

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 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
Low
Linde Eckstein SPF 10 Liquid Make-up Recalled for Subpotent Drug Claim
FDA (Drugs) · 2017-08-23

Same hazard · mis labeling