Cancer_Council

Main information

  • Trade name:
  • Cancer_Council Professional Sunscreen
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Cancer_Council Professional Sunscreen
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220905
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220905

Cancer_Council Professional Sunscreen

ARTG entry for

Medicine Listed

Sponsor

Baxter Laboratories Pty Ltd

Postal Address

1019 Mountain Highway,BORONIA, VIC, 3155

Australia

ARTG Start Date

7/03/2014

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.

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 Professional Sunscreen

Product Type

Single Medicine Product

Effective date

7/03/2014

Warnings

Contains benzyl alcohol (or words to that effect).

(If the medicine contains one sorbate) Contains [insert name of sorbate] OR (if medicine contains two or more sorbates) Contains sorbates [or words to

that effect].

Avoid prolonged exposure in the sun.[or words to that effect]

Contains phenoxyethanol (or words to that effect).

Wear protective clothing, hats and eyewear when exposed to the sun.[Or words to this effect]

Standard Indications

A broad spectrum sunscreening preparation of SPF50+. May assist in preventing some skin cancers

Sunscreen SPF50 Plus

A broad spectrum sunscreening preparation of SPF4 or greater. Can aid in the prevention of premature skin ageing.

A broad spectrum sunscreening preparation of SPF50+. Can aid in the prevention of sunspots

A broad spectrum sunscreening preparation of SPF50+. May reduce the risk of some skin cancers

A broad spectrum sunscreening preparation of SPF50+. Can aid in the prevention of solar keratoses

Specific Indications

No Specific Indications included on Record

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1. Formulation 1

Dosage Form

Lotion

Route of Administration

Topical

Visual Identification

Public Summary

Page 1 of

Produced at 26.11.2017 at 01:52:45 AEDT

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

Active Ingredients

bemotrizinol

30 mg/g

diethylamino hydroxybenzoyl hexyl benzoate

40 mg/g

octocrylene

20 mg/g

zinc oxide

200 mg/g

© 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.

Public Summary

Page 2 of

Produced at 26.11.2017 at 01:52:45 AEDT

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

25-10-2018

Safety of zinc chelate of methionine sulfate for the target species

Safety of zinc chelate of methionine sulfate for the target species

Published on: Wed, 24 Oct 2018 00:00:00 +0200 Zinc chelate of methionine sulfate is intended to be used as a nutritional additive (functional group: compounds of trace elements). The additive is zinc chelated with methionine in a molar ratio 1:1. It is intended to supply zinc as a nutritional additive to all animal species/categories. In 2017, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) adopted an opinion on the safety and efficacy of zinc chelate of methionine su...

Europe - EFSA - European Food Safety Authority Publications

6-7-2017

The European Commission's decision concerning veterinary medicinal products containing zinc oxide

The European Commission's decision concerning veterinary medicinal products containing zinc oxide

On 26 June 2017, the European Commission adopted a decision to withdraw all marketing authorisations for veterinary medicinal products containing zinc oxide administered orally to food producing species. The medicinal products affected by the decision appear from Annex I to the decision.

Danish Medicines Agency

21-3-2017

New recommendation for phasing out zinc oxide for young pigs

New recommendation for phasing out zinc oxide for young pigs

The European Medicines Agency's Committee for Medicinal Products for Veterinary Use (CVMP) has confirmed a previous decision to phase out zinc oxide. Consequently, the CVMP has once more recommended to the European Commission that medicinal products containing zinc oxide for the prevention of diarrhoea in young pigs should be withdrawn from the market.

Danish Medicines Agency

5-1-2017

Re-examination of the CVMP's decision to phase out zinc oxide for young pigs

Re-examination of the CVMP's decision to phase out zinc oxide for young pigs

The European Medicines Agency's Committee for Medicinal Products for Veterinary Use (CVMP) will re-examine the decision to phase out medicinal products containing zinc oxide for the prevention of diarrhoea in young pigs.

Danish Medicines Agency

19-12-2016

Zinc oxide for young pigs to be phased out

Zinc oxide for young pigs to be phased out

The European Medicines Agency's Committee for Medicinal Products for Veterinary Use (CVMP) has recommended to the European Commission that medicinal products containing zinc oxide for the prevention of diarrhoea in young pigs should be withdrawn from the market.

Danish Medicines Agency

There are no news related to this product.