Banana

Main information

  • Trade name:
  • Banana Boat Sport Cool Zone Very High Protection Clear Sunscreen Spray SPF 50+
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Banana Boat Sport Cool Zone Very High Protection Clear Sunscreen Spray SPF 50+
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 216610
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

216610

Banana Boat Sport Cool Zone Very High Protection Clear Sunscreen Spray SPF 50+

ARTG entry for

Medicine Listed

Sponsor

Edgewell Personal Care Australia Pty Ltd

Postal Address

11 Talavera Road Level 5 Building C,Macquarie Park, NSW, 2113

Australia

ARTG Start Date

28/10/2013

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. Banana Boat Sport Cool Zone Very High Protection Clear Sunscreen Spray SPF 50+

Product Type

Single Medicine Product

Effective date

28/10/2013

Warnings

Contains ethanol. (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]

Standard Indications

Sunscreen SPF50 Plus

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

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

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

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

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

Spray, solution

Route of Administration

Topical

Visual Identification

Active Ingredients

butyl methoxydibenzoylmethane

21 mg/g

Public Summary

Page 1 of

Produced at 26.11.2017 at 07:20:42 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

octocrylene

70 mg/g

oxybenzone

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 26.11.2017 at 07:20:42 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

31-10-2018

Updated review of the existing maximum residue levels for imazalil according to Article 12 of Regulation (EC) No 396/2005 following new toxicological information

Updated review of the existing maximum residue levels for imazalil according to Article 12 of Regulation (EC) No 396/2005 following new toxicological information

Published on: Tue, 30 Oct 2018 00:00:00 +0100 In compliance with Article 43 of Regulation (EC) No 396/2005, EFSA received a mandate from the European Commission to provide an update of the reasoned opinion on the review of existing maximum residue levels (MRLs) for imazalil published on 5 September 2017, taking into account the additional information provided on the toxicity of the metabolites R014821, FK‐772 and FK‐284. EFSA did not derive MRL proposals from the post‐harvest uses reported on citrus fru...

Europe - EFSA - European Food Safety Authority Publications

12-6-2018

EU/3/10/811 (Celgene Europe B.V.)

EU/3/10/811 (Celgene Europe B.V.)

EU/3/10/811 (Active substance: N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate) - Transfer of orphan designation - Commission Decision (2018)3809 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/092/10/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/10/810 (Celgene Europe B.V.)

EU/3/10/810 (Celgene Europe B.V.)

EU/3/10/810 (Active substance: N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate) - Transfer of orphan designation - Commission Decision (2018)3808 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/084/10/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/10/794 (Celgene Europe B.V.)

EU/3/10/794 (Celgene Europe B.V.)

EU/3/10/794 (Active substance: N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate) - Transfer of orphan designation - Commission Decision (2018)3803 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/069/10/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/16/1615 (Gilead Sciences Ireland UC)

EU/3/16/1615 (Gilead Sciences Ireland UC)

EU/3/16/1615 (Active substance: 2-ethylbutyl (2S)-2-{[(S)-{[(2R,3S,4R,5R)-5-(4-aminopyrrolo[2,1-f][1,2,4]triazin-7-yl)-5-cyano-3,4-dihydroxytetrahydrofuran-2-yl]methoxy}(phenoxy)phosphoryl]amino}propanoate) - Transfer of orphan designation - Commission Decision (2018)3804 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/197/15/T/01

Europe -DG Health and Food Safety

18-5-2018

EU/3/13/1220 (IQVIA RDS Ireland Limited)

EU/3/13/1220 (IQVIA RDS Ireland Limited)

EU/3/13/1220 (Active substance: Poly[2-[(4-{[1-carboxy-2-(hexadecylcarbamoyl)ethyl]sulfanyl}-2,3-bis({2-[((2S)-2-(2-{[(2R)-2-carbamoyl-(2-{[(2S)-1-ethoxy-3-(3-hydroxy-4oxo-1,4-dihydropyridin-1-yl)-1-oxopropan-2-yl]carbamoyl}ethyl]sulfanyl}-3-{[(2S)-1-ethoxy-3-(3-hydroxy-4-oxo-1,4-dihydropyridin-1-yl)-1-oxopropan-2-yl]carbamoyl}propanamido)-3-(3-hydroxy-4-oxo-1,4-dihydropyridin-1-yl)propanoyl Ethyl ester) )-methoxy]acetyl}oxy)butyl)sulfanyl]-3-(hexadecylcarbamoyl)propanoic acid]-poly(ethylene glycol)-este...

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)

EU/3/16/1639 (Active substance: (1E,6E)-1,7-bis(3,4-dimethoxyphenyl)-4-cyclobutylmethyl-1,6-heptadiene-3,5-dione) - Transfer of orphan designation - Commission Decision (2018)1820 of Wed, 21 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/252/15/T/01

Europe -DG Health and Food Safety