Seagull Milk Sunscreen Lotion SPF50 (Seagull Milk)
Product Name
Seagull Milk Sunscreen Lotion SPF50
Sponsor
ARTG
364151
Date of review outcome
Date cancellation takes effect
Date of publication
Sep-2024
Outcome
Sunscreen is no longer permitted to be supplied
Is it safe to continue using this medicine?
Yes, based on the sponsor's certification. However, follow the recommended actions below.
What action should consumers take?
Consider whether this sunscreen is right for you based on it potentially not working as expected in relation to preventing skin cancer, preventing premature skin ageing, and keeping skin young and glowing.
Be aware that sunscreens are only one component of sun protection from sunburn or skin cancer. Prolonged high-risk sun exposure should be avoided, and sunscreens should be used frequently and re-applied according to label directions for effective sun protection.
Be aware that sunscreens are only one component of sun protection from sunburn or skin cancer. Prolonged high-risk sun exposure should be avoided, and sunscreens should be used frequently and re-applied according to label directions for effective sun protection.
Review scope
Targeted
Information reviewed
ARTG Record, Labels, Manufacturing Documentation, Website
Issues related to safety
The website for this sunscreen contained claims implying it prevents skin cancer. However, the website failed to make consumers aware that sunscreens are only one component of sun protection, recommend avoiding prolonged high-risk sun exposure, and encourage frequent use and reapplication according to the directions. The absence of this mandatory information may result in less effective sun protection in preventing sunburn and skin cancer.
While advertising of this nature is unacceptable, the label for this sunscreen recommends wearing protective clothing/sunglasses/hat in addition to sunscreen, avoiding prolonged sun exposure, and has directions to reapply after 90 minutes or after swimming or towelling. As such, this sunscreen is unlikely to pose an immediate risk to consumer health and safety.
While advertising of this nature is unacceptable, the label for this sunscreen recommends wearing protective clothing/sunglasses/hat in addition to sunscreen, avoiding prolonged sun exposure, and has directions to reapply after 90 minutes or after swimming or towelling. As such, this sunscreen is unlikely to pose an immediate risk to consumer health and safety.
Issues related to efficacy
The website for this sunscreen contained claims about preventing skin cancer, preventing premature skin ageing, and keeping skin young and glowing. However, these claims were not covered by the sponsor's certification that they held evidence to substantiate them.
Actions taken during the review
The TGA required the sponsor to correct the issues with this sunscreen. The sponsor did not sufficiently address the issues. The TGA cancelled this sunscreen and withdrew permission for further supply.
Grounds for cancellation
The sponsor has refused or failed to comply with a condition to which the inclusion of the goods is subject (paragraph 30(2)(c) of the Act).
The goods do not conform to a standard applicable to the goods (paragraph 30(2)(e) of the Act).
The goods do not conform to a requirement relating to advertising applicable to the goods under Part 5-1 or the regulations (paragraph 30(2)(ea) of the Act).
The goods do not conform to a standard applicable to the goods (paragraph 30(2)(e) of the Act).
The goods do not conform to a requirement relating to advertising applicable to the goods under Part 5-1 or the regulations (paragraph 30(2)(ea) of the Act).