# FDA recall D-0640-2025

> **GRACE & FIRE PTY LTD** · Class II · drug recall initiated 2025-08-22.

## Product

Ultra Violette, Velvet Screen SPF 50, Blurring Mineral Skinscreen, Zinc Oxide 22.75%, a) 15 mL, 0.5 fl. oz. per tube, NDC 84803-106-01, UPC 9355909006068, b) 50 mL, 1.7 fl. oz. per tube, NDC 84803-106-02, UPC 9355909005924, Distributed by: Grace & Fire USA Inc., 251 Little Falls Drive, New Castle Wilmington, Delaware 19808.

## Reason for recall

Subpotent/Super-potent Product: Testing of the SPF 50 sunscreen revealed inconsistency in SPF results ranging from SPF 4, 10, 21, 26, 33, 60, 61, and 64.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0640-2025
- **Recalling firm:** GRACE & FIRE PTY LTD
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-08-22
- **Report date:** 2025-09-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Cremorne, N/A, Australia

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0640-2025

## Citation

> AI Analytics. FDA recall D-0640-2025. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/D-0640-2025. Source: US FDA. Licensed CC0.

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