AUSTRALIA'

Main information

  • Trade name:
  • AUSTRALIA' S NO. 1 KIDS SPF 60+ SUN BLOCK MILK 125 mL bottle
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • AUSTRALIA' S NO. 1 KIDS SPF 60+ SUN BLOCK MILK 125 mL bottle
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 94913
  • Last update:
  • 01-12-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

94913

AUSTRALIA' S NO. 1 KIDS SPF 60+ SUN BLOCK MILK 125 mL bottle

ARTG entry for

Medicine Listed (Export Only)

Sponsor

Rondeb Pty Ltd

Postal Address

41/225 Beaconsfield Parade,MIDDLE PARK, VIC, 3206

Australia

ARTG Start Date

16/06/2003

Product category

Medicine

Status

Active

Approval area

Export only Medicines

Conditions

Except where the sponsor has been contracted by an overseas partry to manufacturer the goods and that party will be responsible for placing the goods

on the market in countries other than Australia, the sponsor must have and shall retain, while the goods remain listed, evidence necessary to

substantiate and support the accuracy of the indications in relation to the listed goods, and upon the request of the Head, Office of Prescription

Medicines Authorisation Branch, Therapeutic Goods Administration, shall produce such evidence to this officer.

The sponsor shall hold stability data to support the claimed shelf life of the listed medicine according to the labelled storage conditions except where: (i)

each overseas importer accepts responsibility for holding stability data for this product; (ii) the sponsor has a written agreement to this effect from each

overseas importer; and (iii) the sponsor retains copies of all such agreements while the medicine remains listed on the ARTG.

This product must not be supplied for sale in Australia, including supply via duty free outlets.

Products

1. AUSTRALIA' S NO. 1 KIDS SPF 60+ SUN BLOCK MILK 125 mL bottle

Product Type

Single Medicine Product

Effective date

16/06/2003

Warnings

No Warnings included on Record

Standard Indications

Specific Indications

SPF 60+ SUNSCREEN

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Not Required

Not scheduled. Not considered by committee

Components

1. LOTION

Dosage Form

Lotion

Route of Administration

Topical

Visual Identification

Active Ingredients

4-methylbenzylidene camphor

20 mg/g

butyl methoxydibenzoylmethane

25 mg/g

octocrylene

15 mg/g

octyl methoxycinnamate

100 mg/g

titanium dioxide

59 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 1 of

Produced at 01.12.2017 at 08:06:28 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