Key Sun Clear Zinke Sensitive Skin SPF50+ (Key-Sun Laboratories Pty Ltd)
Product Name
Key Sun Clear Zinke Sensitive Skin SPF50+
Sponsor
ARTG
285460
Date of review outcome
Date of publication
Jun-20
Outcome
Sunscreen continues to be permitted for supply. Batches released from 31 May 2020 must carry a corrected label.
Is it safe to continue using this medicine?
Yes, if you follow the recommended actions below
What action should consumers take?
Use sunscreens as directed in order to reduce the risk of some skin cancers
Review scope
Random
Information reviewed
ARTG Record, Labels, Website
Issues related to safety
The label of the sunscreen advertises a claim about reducing 'the risk of cancers caused by exposure to the harsh sun's rays'. Advertisements of therapeutic goods are strictly prohibited from mentioning cancer with a narrow exception for sunscreen products to be able to claim they may reduce the risk of skin cancers only. As such, the general nature of the cancer claim on the label is not permitted.
Issues related to efficacy
The efficacy of the medicine was not assessed as part of this review
Actions taken during the review
TGA required the sponsor to correct the issues with the sunscreen. The sponsor updated the label to clarify that use of the sunscreen may reduce the risk of skin cancers only.