Sunscreen guideline move
May 7, 2010
THE Therapeutic Goods
Administration has published new
proposed guidelines for the
regulation of sunscreens.
The changes would apply to the
Australian Regulatory Guidelines for
OTC Medicines, with the proposal
set to see the document “provide a
complete, clear and single source
of information on Australian
requirements for sunscreen
regulated as therapeutic goods”.
The revision would replace the
current chapter 10 ‘Sunscreens’ in
the guidelines and is a 32-page
document comprehensively
covering a range of topics including
definitions of therapeutic or
cosmetic subscreens, labelling, SPF
testing, stability testing, microbial
content and active ingredients.
SPF declared on the label of
therapeutic sunscreens should be
determined by testing on human
skin in accordance with the trans-
Tasman standard AS/NZS
2604:1998, and the document also
mandates that sunscreens
marketed in Australia must be
labelled with a use-by date.
It also lists approved ingredients
as well as clarifying the proposal for
naming of new substances if
they’re to be used in sunscreens.
The consultation document is
now online at www.tga.gov.au and
interested parties are asked to
respond by close of business on
Friday 18 June 2010.
The above article was sent to subscribers in Pharmacy Daily's issue from 07 May 10To see the full newsletter, see the embedded issue below or CLICK HERE to download Pharmacy Daily from 07 May 10
