BONDI SANDS SPF30 FRAGRANCE FREE SUNSCREEN SPRAY

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

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Active ingredient:
butyl methoxydibenzoylmethane,homosalate,octocrylene,octyl salicylate
Available from:
Bondi Sands Pty Ltd
Authorization status:
Listed (Export Only)
Authorization number:
348874

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Public Summary

Summary for ARTG Entry:

348874

BONDI SANDS SPF30 FRAGRANCE FREE SUNSCREEN SPRAY

ARTG entry for

Medicine Listed (Export Only)

Sponsor

Bondi Sands Pty Ltd

Postal Address

Suite 11 / 574 Plummer Street, Port Melbourne, VIC, 3207

Australia

ARTG Start Date

18/11/2020

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 . BONDI SANDS SPF30 FRAGRANCE FREE SUNSCREEN SPRAY

Product Type

Single Medicine Product

Effective Date

18/11/2020

Permitted Indications

No Permitted Indications included on Record

Indication Requirements

No Indication Requirements included on Record

Standard Indications

No Standard Indications included on Record

Specific Indications

No Specific Indications included on Record

Warnings

No Warnings included on Record

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Aerosol Can

Not recorded

Not recorded

Not recorded

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1 .

Dosage Form

Spray, pressurised

Route of Administration

Topical

Visual Identification

Smooth, white to off-white glossy liquid

Active Ingredients

butyl methoxydibenzoylmethane

18 mg/g

homosalate

60 mg/g

octocrylene

48 mg/g

Public Summary

Page 1 of

Produced at 11.01.2021 at 10:42:23 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

octyl salicylate

30 mg/g

Other Ingredients (Excipients)

acrylates/C10-30 alkyl acrylate crosspolymer

alkyl (C12-15) benzoate

Aloe vera

caprylyl glycol

cetyl dimeticone

cocoglycerides

disodium edetate

dl-alpha-tocopheryl acetate

glycerol

methyl ether

octanohydroxamic acid

PEG-15 cocamine

PEG-40 stearate

phenoxyethanol

purified water

saccharide isomerate

trolamine

white beeswax

© 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 10:42:23 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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