Public Summary: 1 - Cancer - Council Ultra Cooling Sunscreen SPF50+

Public Summary
Summary for ARTG Entry: 238198 Cancer_Council Ultra Cooling Sunscreen SPF50+
ARTG entry for Medicine Listed
Sponsor VitalityBrands Worldwide Pty Ltd

Postal Address Level 2 / 415 Riversdale Road, HAWTHORN EAST, VIC, 3123
Australia
ARTG Start Date 18/05/2015
Product Category Medicine
Status Active
Approval Area Listed Medicines
Conditions
The sponsor shall keep records relating to this listed medicine as are necessary to: (a) Expedite recall if necessary of any batch of the listed medicine, (b)
Identify the manufacturer(s) of each batch of the listed medicine. Where any part of or step in manufacture in Australia of the listed medicine is sub-contracted
to a third party who is not the sponsor, copies of relevant Good Manufacturing Practice agreements relation to such manufacture shall be kept.
The sponsor shall retain records of the distribution of the listed medicine for a period of five years and shall provide the records or copies of the records to the
Complementary Medicines Branch, Therapeutic Goods Administration, upon request.
The sponsor of the listed medicine must not, by any means, intentionally or recklessly advertise the medicine for an indication other than those accepted in
relation to the inclusion of the medicine in the Register.
Public Summary
All reports of adverse reactions or similar experiences associated with the use or administration of the listed medicine shall be notified to the Head, Office of
Product Review, Therapeutic Goods Administration, as soon as practicable after the sponsor of the goods becomes aware of those reports. Sponsors of listed
medicines must retain records of such reports for a period of not less than 18 months from the day the Head, Office of Product Review is notified of the report
or reports.
The sponsor shall not supply the listed medicine after the expiry date of the goods.
Where a listed medicine is distributed overseas as well as in Australia, product recall or any other regulatory action taken in relation to the medicine outside
Australia which has or may have relevance to the quality, safety or efficacy of the goods distributed in Australia, must be notified to the National Manager
Therapeutic Goods Administration, immediately the action or information is known to the sponsor.
Products
1 . Cancer_Council Ultra Cooling Sunscreen SPF50+

Product Type Single Medicine Product Effective Date 8/05/2019
Permitted Indications
May assist in preventing some skin cancers (sunscreen)
May reduce the risk of some skin cancers (sunscreen)
SPF 50 PLUS Broad spectrum very high protection sunscreen
Can aid in the prevention of premature skin ageing (sunscreen)
Can aid in the prevention of solar keratosis (sunscreen)
Can aid in the prevention of sunspots (sunscreen)
Indication Requirements
Indication can only be used for sunscreen products with an SPF rating of 30 or higher.
Indication for use in sunscreen products only.
Standard Indications
No Standard Indications included on Record
Specific Indications
No Specific Indications included on Record
Warnings
(If medicine contains one hydroxybenzoate) Contains [insert name of hydroxybenzoate] OR (If medicine contains two or more hydroxybenzoates) Contains
hydroxybenzoates [or words to that effect].
Contains phenoxyethanol (or words to that effect).
Contains benzyl alcohol (or words to that effect).
Avoid prolonged exposure in the sun.[or words to that effect]
Wear protective clothing, hats and eyewear when exposed to the sun.[Or words to this effect]
Page 1 of 2 Produced at 17.08.2020 at 10:23:43 AEST

This is not an ARTG Certificate document.
The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.
Visit www.tga.gov.au for contact information
Additional Product information
Pack Size/Poison information
Pack Size Poison Schedule
Components
1 . Formulation 1
Dosage Form Lotion

Route of Administration Topical
Visual Identification
Active Ingredients
butyl methoxydibenzoylmethane 40 mg/g

homosalate 100 mg/g
octocrylene 80 mg/g
octyl salicylate 50 mg/g
Other Ingredients (Excipients)
alkyl (C12-15) benzoate

Aloe vera
Public Summary
benzyl alcohol
carbomer 941
citric acid
dl-alpha-tocopheryl acetate
ethyl hydroxybenzoate
Fragrance (perfume)
hyetellose
menthyl lactate
methyl hydroxybenzoate
PEG-15 cocamine
PEG-40 stearate
phenoxyethanol
propyl hydroxybenzoate
propylene glycol
purified water
silicon dioxide
trolamine
white beeswax
© Commonwealth of Australia. This work is copyright. You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior
written approval from the Commonwealth. Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.
Page 2 of 2 Produced at 17.08.2020 at 10:23:43 AEST

This is not an ARTG Certificate document.
The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.
Visit www.tga.gov.au for contact information

Public Summary: 1 - Cancer - Council Ultra Cooling Sunscreen SPF50+

Uploaded by

Copyright:

Available Formats

Public Summary: 1 - Cancer - Council Ultra Cooling Sunscreen SPF50+

Uploaded by

Document Information

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

Public Summary: 1 - Cancer - Council Ultra Cooling Sunscreen SPF50+

Uploaded by

Copyright:

Available Formats

Public Summary

ARTG entry for Medicine Listed

Sponsor VitalityBrands Worldwide Pty Ltd

1 . Cancer_Council Ultra Cooling Sunscreen SPF50+

No Standard Indications included on Record

No Specific Indications included on Record

Page 1 of 2 Produced at 17.08.2020 at 10:23:43 AEST

Pack Size/Poison information

Pack Size Poison Schedule

Dosage Form Lotion

butyl methoxydibenzoylmethane 40 mg/g

Other Ingredients (Excipients)

alkyl (C12-15) benzoate

Page 2 of 2 Produced at 17.08.2020 at 10:23:43 AEST

You might also like