ACTIVE

Main information

Documents

Localization

  • Available in:
  • ACTIVE SUNSCREEN SPF50+
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 210257
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

210257

ACTIVE SUNSCREEN SPF50+

ARTG entry for

Medicine Listed

Sponsor

Scental Pacific Pty Ltd

Postal Address

PO Box 479,BAYSWATER, VIC, 3153

Australia

ARTG Start Date

29/05/2013

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. ACTIVE SUNSCREEN SPF50+

Product Type

Single Medicine Product

Effective date

29/05/2013

Warnings

Contains phenoxyethanol (or words to that effect).

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

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

Avoid contact with eyes (or words to that effect).

If irritation develops, discontinue use. (Not less than 1.5 mm in height)

Standard Indications

Sunscreen SPF50 Plus

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

Specific Indications

SPF50+ Sunscreen Lotion

4 Hours Water Resistant

Broad Spectrum

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

4-methylbenzylidene camphor

40 mg/g

Public Summary

Page 1 of

Produced at 27.11.2017 at 09:55:18 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

butyl methoxydibenzoylmethane

40 mg/g

octocrylene

80 mg/g

oxybenzone

30 mg/g

phenylbenzimidazole sulfonic acid

35 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 27.11.2017 at 09:55:18 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

9-11-2018

Safety assessment of the active substance polyacrylic acid, sodium salt, cross‐linked, for use in active food contact materials

Safety assessment of the active substance polyacrylic acid, sodium salt, cross‐linked, for use in active food contact materials

Published on: Thu, 08 Nov 2018 00:00:00 +0100 The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of polyacrylic acid, sodium salt, cross‐linked, FCM substance No 1015, which is intended to be used as a liquid absorber in the packaging of fresh or frozen foods such as meat, poultry and seafood as well as fresh fruits and vegetables. Specific migration tests were not performed due to the high absorption of liquids by the substance. The Panel noted that if polya...

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EU/3/16/1762 (Pharma Gateway AB)

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Orphacol (Laboratoires CTRS)

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18-4-2018

EU/3/18/2007 (Dr Philippe Moullier)

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Europe -DG Health and Food Safety

21-3-2018

EU/3/17/1861 (Roivant Sciences Ireland Limited)

EU/3/17/1861 (Roivant Sciences Ireland Limited)

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Europe -DG Health and Food Safety

21-3-2018

EU/3/16/1639 (IQVIA RDS Ireland Limited)

EU/3/16/1639 (IQVIA RDS Ireland Limited)

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Europe -DG Health and Food Safety

21-3-2018

EU/3/14/1363 (IQVIA RDS Ireland Limited)

EU/3/14/1363 (IQVIA RDS Ireland Limited)

EU/3/14/1363 (Active substance: 4-[[(1S,4S)-5-[[4-[4-(oxazol-2-yl)phenoxy]phenyl]methyl]-2,5-diazabicyclo[2.2.1]hept-2-yl]methyl]benzoic acid) - Transfer of orphan designation - Commission Decision (2018)1818 of Wed, 21 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/131/14/T/01

Europe -DG Health and Food Safety

8-3-2018

Mycophenolate mofetil, mycophenolic acid

Mycophenolate mofetil, mycophenolic acid

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Europe -DG Health and Food Safety

5-2-2018

Oxybee (Dany Bienenwohl GmbH)

Oxybee (Dany Bienenwohl GmbH)

Oxybee (Active substance: oxalic acid dihydrate) - New authorisation - Commission Decision (2018)684 of Mon, 05 Feb 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/4296

Europe -DG Health and Food Safety

24-11-2017

Gadolinium

Gadolinium

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Europe -DG Health and Food Safety