Australian Sunscreen Council statement on today’s Ultra Violette withdrawal

22 August 2025 — Brisbane

The Australian Sunscreen Council (ASC) notes today’s ABC News report that Ultra Violette has withdrawn its Lean Screen product after additional testing returned SPF results ranging from 4 to 64, well below the label claim in several tests. We support the decision to pull the product and refund customers. ABC

This development underscores a long-standing issue our members have been campaigning on with the Therapeutic Goods Administration (TGA): imported zinc oxide entering Australian supply chains that does not meet pharmacopoeial standards. When the active UV filter is sub-standard, batch-to-batch performance can drift and, in the worst cases, fail to meet the labelled SPF.

What the rules already require (and why enforcing them matters)

• TGA’s sunscreen guidance (updated August 2025) confirms that listed therapeutic sunscreens must comply with AS/NZS 2604:2021 and its referenced ISO methods (ISO 24444/24443/16217) for establishing SPF and UVA performance. Therapeutic Goods Administration (TGA)+1

• The same guidance sets default standards for ingredients—BP/Ph. Eur./USP–NF—that apply to therapeutic goods, including sunscreens. Sponsors must hold specifications against these standards. Therapeutic Goods Administration (TGA)

• TGA’s GMP interpretations further expect manufacturers to sample all containers of active starting materials, perform identity testing on each, and base specifications and release decisions on manufacturer-issued Certificates of Analysis (not broker-transcribed) within a qualified supplier program. Therapeutic Goods Administration (TGA)+1

  
  

What we were told in inspections discussions

In ASC’s discussions with the then TGA Director of Inspections (now former), we were advised that, at that time, the TGA had not taken specific steps to address the quality of imported zinc oxide entering sunscreen manufacturing, and that routine inspections did not assess whether Australian manufacturers had evaluated the safety of the sunscreens they were making as part of the inspection scope. We raise this to highlight a regulatory gap that needs urgent closure to protect consumers and honest manufacturers. (ASC account of those discussions.)

What must improve now

1. Active-grade verification at source: During GMP inspections, verify and record evidence that every zinc oxide lot used meets a BP/Ph. Eur./USP–NF monograph (assay, ID, impurity limits) with a manufacturer CoA, and link this to batch records. Therapeutic Goods Administration (TGA)+1

2. Sampling discipline: Confirm manufacturers sample all active-material containers and conduct required identity and critical tests on every delivery, not just periodically. Therapeutic Goods Administration (TGA)

3. Targeted raw-material audits: Where SPF results show unusual spread or drift, require active-material audits (including re-testing against monographs) as part of CAPA and the Pharmaceutical Quality System. Therapeutic Goods Administration (TGA)

4. Transparent compliance signals: Publish de-identified findings on raw-material non-compliance to deter use of industrial grades in therapeutic sunscreens.

5. Risk-based market checks: Expand post-market sampling and finished-goods SPF verification where imported actives or third-party manufacturing are involved. (Standards-aligned and consumer-protective.) Therapeutic Goods Administration (TGA)

   
   

Bottom line

Sunscreens are therapeutic goods because lives depend on them. The standards and test methods are clear; the missing piece has been consistent enforcement at the raw-material gate. Tightening inspection focus on active-ingredient quality will reduce the risk of out-of-spec batches reaching consumers and restore confidence in SPF labels. Therapeutic Goods Administration (TGA)

The ASC stands ready to assist the TGA with practical checklists and technical input to make these safeguards routine.