SPF 50+ UV Protection Sun Cream

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

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Active ingredient:
butyl methoxydibenzoylmethane,octocrylene,oxybenzone,phenylbenzimidazole sulfonic acid
Available from:
Careline Australia Pty Ltd
Authorization status:
Listed
Authorization number:
323603

Public Summary

Summary for ARTG Entry:

323603

SPF 50+ UV Protection Sun Cream

ARTG entry for

Medicine Listed

Sponsor

Careline Australia Pty Ltd

Postal Address

41-43 Bellona Avenue,REGENTS PARK, NSW, 2143

Australia

ARTG Start Date

16/09/2019

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. SPF 50+ UV Protection Sun Cream

Product Type

Single Medicine Product

Effective date

16/09/2019

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

Warnings

For external use only.

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

Avoid contact with eyes (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

Public Summary

Page 1 of

Produced at 29.09.2019 at 04:41:19 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

Components

1. Formulation 1

Dosage Form

Cream

Route of Administration

Topical

Visual Identification

Active Ingredients

butyl methoxydibenzoylmethane

25 mg/g

octocrylene

70 mg/g

oxybenzone

30 mg/g

phenylbenzimidazole sulfonic acid

20 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 29.09.2019 at 04:41:19 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

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