Broad spectrum sunscreens with an SPF of 30 or higher

Notice of permission to use restricted representations under section 42DK of the Therapeutic Goods Act 1989^[1]

I, Pio Cesarin, Assistant Secretary, Regulatory Practice, Education and Compliance Branch, Therapeutic Goods Administration and delegate of the Secretary to the Department of Health for the purposes of section 42DK of the Therapeutic Goods Act 1989 (the Act), give notice under subsection 42DK (1) of the Act of permission for the restricted representations described in paragraph (a) below to be used in advertisements directed to consumers (including their use on the label of the good/s or in information included in the package in which the goods are contained) for the goods identified in paragraph (b)^[2], provided the advertisement also includes the message identified in paragraph (c):

1. A representation to the effect that goods described in paragraph (b) below:
   • "may assist in preventing some skin cancers"
   • "may reduce the risk of some skin cancers"
2. Broad spectrum sunscreens with an SPF of 30 or higher.
3. Words to the effect of highlighting:
   • The need for sunscreens to be applied and reapplied as directed on the label,
   • The need for avoidance of prolonged exposure to the sun,
   • The importance of wearing protective clothing, hats and eyewear.

This permission revokes and substitutes the permission given by me under regulation 7C(1) of the Therapeutic Goods Regulations 1990 on 13 September 2002, and published in the Commonwealth of Australia Gazette No. GN 38, 25 September 2002, permitting the use of certain restricted representations in relation to broad spectrum 30+ sunscreens.

Dated this 4th day of August 2017

Pio Cesarin
Delegate of the Secretary to the Department of Health; and
Assistant Secretary
Regulatory Practice, Education and Compliance Branch

1. This permission takes effect on the day on which it is published on TGA's website.
2. This permission permits advertisers to use the restricted representations set out in this notice without contravening paragraph 42DL(1)(c) of the Therapeutic Goods Act 1989 (the Act) and section 42DM of the Act (by virtue of an alleged breach of section 5(2) of the Therapeutic Goods Advertising Code 2015). However, the advertisement in which the representations are made must otherwise comply with the advertising requirements set out in the Act and the Therapeutic Goods Advertising Code 2015.