Bali Body Face & Body Sunscreen Spray SPF50+ (Bali Body Pty Ltd)
Product Name
Bali Body Face & Body Sunscreen Spray SPF50+
Sponsor
Date of review outcome
Date of publication
Sep-2023
Outcome
Sunscreen continues to be permitted for supply. Batches released from 4 January 2023 must carry a corrected label with the updated directions for use.
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?
Be aware that this sunscreen's directions for use have been revised:
Shake can well before use. Make sure you are in a well-ventilated area to avoid inhalation. Do not apply this sunscreen in windy conditions.
Hold the can 10-15 cm away from the body and spray liberally and evenly until the product looks and feels wet on the skin. Do not spray directly onto the face, instead spray onto hands and then apply to the face.
Re-apply every 2 hours or more often when sweating and after swimming, exercise or towel drying.
Shake can well before use. Make sure you are in a well-ventilated area to avoid inhalation. Do not apply this sunscreen in windy conditions.
Hold the can 10-15 cm away from the body and spray liberally and evenly until the product looks and feels wet on the skin. Do not spray directly onto the face, instead spray onto hands and then apply to the face.
Re-apply every 2 hours or more often when sweating and after swimming, exercise or towel drying.
Review scope
Targeted (See Additional Information below)
Information reviewed
ARTG Record, Evidence, Labels, Manufacturing Documentation, Website
Issues related to safety
The directions for use on the label and website for this sunscreen did not provide sufficient instructions for its use on the face. Directly spraying an aerosol sunscreen onto the face may result in inadvertent inhalation, local irritation of the upper airways, coughing and sneezing.
The sponsor corrected the directions for use on the label, the website and communicated the updated directions for use to affected consumers. As such, it is unlikely to pose an immediate risk to consumer health and safety.
The sponsor corrected the directions for use on the label, the website and communicated the updated directions for use to affected consumers. As such, it is unlikely to pose an immediate risk to consumer health and safety.
Issues related to efficacy
The directions for use on the label and website for this sunscreen did not provide sufficient instructions for how to use it effectively.
Actions taken during the review
The TGA required the sponsor to correct the issues with this sunscreen. The sponsor updated the label and website to include updated directions for use, and communicated the change to affected consumers.
Additional information
This sunscreen was targeted to check its compliance with safety and efficacy requirements