# FDA recall D-0977-2016

> **Bayer Health Care LLC** · Class II · drug recall initiated 2016-05-10.

## Product

Coppertone SUNSCREEN LOTION, CLEARLY SHEER, BROAD SPECTRUM SPF 50, 5 FL OZ (147mL), OTC, Dist by: Bayer HealthCare LLC, Whippany, NJ 07981 --- NDC 11523-7391-1, UPC 00041100005762

## Reason for recall

Labeling; Product Contains Undeclared API (Oxybenzone)

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0977-2016
- **Recalling firm:** Bayer Health Care LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2016-05-10
- **Report date:** 2016-06-15
- **Termination date:** 2016-10-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Cleveland, TN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0977-2016

## Citation

> AI Analytics. FDA recall D-0977-2016. Retrieved 2026-06-01 from https://api.ai-analytics.org/recall/D-0977-2016. Source: US FDA. Licensed CC0.

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