| TGA Action ID |
RC-2025-RN-00738-1 |
| Type of Product |
Medicine |
| Product Name/Description |
Ultra Violette Lean Screen SPF 50+
All batches and expiry dates |
| ARTG Number |
332788 |
| Action Type |
Recall |
| Action Level |
Consumer |
| Hazard Classification |
Class II |
| Reason for the Action |
Independent testing of Ultra Violette Lean Screen SPF 50+ demonstrated a pattern of inconsistency in SPF level of the product, spanning from an SPF level of 4 to 64.32.
People using this product may be at an increased risk of sunburn during use and reduced skin cancer prevention long term.
To date, no serious adverse events have been reported. Ultra Violette (UV) continues to obtain further independent testing to identify a potential root cause of the problem, however will be withdrawing the product from the market while these investigations continue. |
| Instructions for Customers/Users |
Retailers are to: - Inspect and immediately quarantine any stock on site. - Once all stock is quarantined on site it can be destroyed as per local policy. - Contact Ultra Violette to discuss a refund.
Consumers are to: • If product purchased directly from the Ultra Violette website: - Visit Ultra Violette’s website at https://ultraviolette.com.au/ to obtain information on a refund. • If product purchased from a retailer other than Ultra Violette: - Return the product to the place of purchase for a refund.
Replacement Stock: UV is discontinuing the Product.
This action has been closed out on 21/11/2025 |
| Action Commencement Date |
26/08/2025 |
| Responsible Entity |
|
| Contact Information |
0434 570 711 - Rebecca Jefferd |