Coverup Sunscreen

Australia - English - Department of Health (Therapeutic Goods Administration)

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Active ingredient:
4-methylbenzylidene camphor,butyl methoxydibenzoylmethane,diethylamino hydroxybenzoyl hexyl benzoate,homosalate,octocrylene
Available from:
Russpet Pty Ltd
Authorization status:
Listed
Authorization number:
349174

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Public Summary

Summary for ARTG Entry:

349174

Coverup Sunscreen

ARTG entry for

Medicine Listed

Sponsor

Russpet Pty Ltd

Postal Address

PO Box 92, Sandown Village, VIC, 3171

Australia

ARTG Start Date

20/11/2020

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.

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 . Coverup Sunscreen

Product Type

Single Medicine Product

Effective Date

20/11/2020

Permitted Indications

May assist in preventing some skin cancers (sunscreen)

May reduce the risk of some skin cancers (sunscreen)

SPF 50 Broad spectrum high protection sunscreen

SPF 50 PLUS Broad spectrum very high protection sunscreen

Indication Requirements

Indication for use in sunscreen products only.

Indication can only be used for sunscreen products with an SPF rating of 30 or higher.

Standard Indications

No Standard Indications included on Record

Specific Indications

No Specific Indications included on Record

Warnings

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]

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1 . Formulation 1

Dosage Form

Cream

Route of Administration

Topical

Visual Identification

Active Ingredients

4-methylbenzylidene camphor

20 mg/g

Public Summary

Page 1 of

Produced at 11.01.2021 at 10:30:30 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

20 mg/g

diethylamino hydroxybenzoyl hexyl benzoate

15 mg/g

homosalate

100 mg/g

octocrylene

50 mg/g

Other Ingredients (Excipients)

alkyl (C12-15) benzoate

aluminium starch octenylsuccinate

cetostearyl alcohol

chlorphenesin

dimeticone 5

dl-alpha-tocopheryl acetate

ethylhexylglycerin

glycerol

iodopropynyl butylcarbamate

PEG-30 dipolyhydroxystearate

phenoxyethanol

polyglyceryl-3 diisostearate

purified water

silica dimethyl silylate

sodium chloride

triacontanyl PVP

© 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 11.01.2021 at 10:30:30 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

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