The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0640-2025·Announced 2025-09-17

Mineral sunscreen recalled after SPF testing ranged from 4 to 64

Ultra Violette Velvet Screen SPF 50 mineral sunscreen is recalled nationwide after testing produced inconsistent SPF results ranging from SPF 4 to 64. 49,275 tubes are affected.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Rubric level 3 covers risk-of-harm products where injury has not yet been reported; a sunscreen that may deliver a fraction of its labeled SPF is a potential harm and no injuries are reported.

Plain-English summary

Ultra Violette Velvet Screen SPF 50 Blurring Mineral Skinscreen, containing zinc oxide 22.75%, in 15 mL (0.5 fl oz) tubes under NDC 84803-106-01 and 50 mL (1.7 fl oz) tubes under NDC 84803-106-02, is being recalled. Affected lots are A2455 expiring 12/31/2026 for the 15 mL tubes, and A2453A, A2453B expiring 11/30/2026 and A2454A for the 50 mL tubes. The recall covers 49,275 tubes distributed nationwide.

The recall was issued because the product is subpotent or superpotent: testing of the SPF 50 sunscreen revealed inconsistency in SPF results ranging from SPF 4, 10, 21, 26, 33, 60, 61 and 64. The FDA classified the action as Class II.

Customers holding these lots should stop relying on the product for sun protection and can return it to the place of purchase.

The recalled product

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…
Manufacturer
GRACE & FIRE PTY LTD
Category
Drug — Sunscreen
Hazard
Affected units
49,275

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 (8)

  • Lot #s: a) 15 mL tubes: A2455
  • exp 12/31/2026
  • b) 50 mL tubes: A2453A
  • A2453B
  • exp 11/30/2026
  • A2454A
  • A2550
  • exp 02/28/2027

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by GRACE & FIRE PTY LTD 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 2 products in this recall →

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