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OMBRA SPF50 KIDS SUNSCREEN LOTION (Scental Pacific Pty Ltd)
Product Name
OMBRA SPF50 KIDS SUNSCREEN LOTION
Sponsor
ARTG
281595
Date of review outcome
Date of publication
Jun-22
Outcome
Sunscreen is no longer permitted to be supplied
Is it safe to continue using this medicine?
No, continued use is not recommended as its safety is not considered acceptable for a listed sunscreen
What action should consumers take?
Do not use this sunscreen because it is past its expiry date
Review scope
Targeted (see Additional Information below)
Information reviewed
ARTG Record, Laboratory Results, Sample
Issues related to safety
The sunscreen did not meet the standard required for an SPF50 broad spectrum sunscreen to provide sufficient protection against UVA radiation. Broad spectrum sunscreens are tested to ensure there is sufficient protection from UVA radiation (as well as UVB), as it is now recognised that UVA radiation also contributes to the development of skin cancer. The last batch ([B]13618) of the sunscreen expired on 31 December 2021 and consumers should not be using expired sunscreens.
Issues related to efficacy
The sunscreen did not have the capacity to protect against UVA radiation to a level required for an SPF50 broad spectrum claim
Actions taken during the review
The sponsor cancelled the sunscreen and withdrew it from further supply
Additional information
This sunscreen was targeted to check its compliance in relation to requirements for broad spectrum sunscreens marketed towards infants and children