LETAN ZINC STICK SPF50+ - NUDE

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

Buy It Now

Active ingredient:
4-methylbenzylidene camphor,diethylamino hydroxybenzoyl hexyl benzoate,zinc oxide
Available from:
Heritage Brands Ltd
INN (International Name):
4-methylbenzylidene camphor,diethylamino hydroxybenzoyl hexyl benzoate,zinc oxide
Authorization status:
Listed
Authorization number:
291744

Read the complete document

Public Summary

Summary for ARTG Entry:

291744

LETAN ZINC STICK SPF50+ - NUDE

ARTG entry for

Medicine Listed

Sponsor

Heritage Brands Ltd

Postal Address

PO Box 1435,CLAYTON SOUTH, VIC, 3169

Australia

ARTG Start Date

20/07/2017

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. LETAN ZINC STICK SPF50+ - NUDE

Product Type

Single Medicine Product

Effective date

20/07/2017

Warnings

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

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).

Standard Indications

Sunscreen SPF50 Plus

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

Stick

Route of Administration

Topical

Visual Identification

Active Ingredients

4-methylbenzylidene camphor

40 mg/g

diethylamino hydroxybenzoyl hexyl benzoate

50 mg/g

zinc oxide

250 mg/g

Public Summary

Page 1 of

Produced at 24.11.2017 at 07:49:05 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

© 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 24.11.2017 at 07:49:05 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

Similar products

Search alerts related to this product

Share this information