# FDA recall D-0849-2016

> **Sesderma, SL** · Class II · drug recall initiated 2015-10-15.

## Product

Repaskin 30 (octacrylene 4%, oxybenzone 3%, octisalate 3%, octinoxate 3% Avobenzone 3%) Facial Sunscreen gel cream, Broad Spectrum SPF 30, 1.7 fl oz (50 mL) bottle, over the counter, Manufactured by Sesderma S.L., Valencia, Spain, NDC 63181-0010-1

## Reason for recall

cGMP Deviations; product does not comply with cGMP requirements

## Distribution

Distributed to following states: FL, PR, CO, GA.

## Key facts

- **Recall number:** D-0849-2016
- **Recalling firm:** Sesderma, SL
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2015-10-15
- **Report date:** 2016-05-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Rafelbunol, N/A, Spain

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0849-2016

## Citation

> AI Analytics. FDA recall D-0849-2016. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-0849-2016. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*