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.
What this means for you
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
- 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 →Related recalls
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See all →- LowLinde Eckstein Recalls Make Up Perfect SPF 10 Liquid Make-up
FDA (Drugs) · 2017-08-23
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- LowLinde Eckstein SPF 10 Liquid Make-up Recalled for Subpotent Sun Protection
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- LowLinde Eckstein SPF 10 Liquid Make-up Recalled for Subpotent Drug Claim
FDA (Drugs) · 2017-08-23
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