OUTDOORPLUS Dry Touch SPF50+

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

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Active ingredient:
butyl methoxydibenzoylmethane,homosalate,octocrylene,octyl salicylate
Available from:
Penline Mon Ami Australia Pty Ltd
Authorization status:
Listed
Authorization number:
346487

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Public Summary

Summary for ARTG Entry:

346487

OUTDOORPLUS Dry Touch SPF50+

ARTG entry for

Medicine Listed

Sponsor

Penline Mon Ami Australia Pty Ltd

Postal Address

PO Box 605, MATRAVILLE, NSW, 2036

Australia

ARTG Start Date

23/10/2020

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 . OUTDOORPLUS Dry Touch SPF50+

Product Type

Single Medicine Product

Effective Date

23/10/2020

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

Label statement: Prolonged exposure to the sun should be avoided, it is important to wear protective clothing, hats and eyewear when exposed to the sun.

Product should be kept out of the eyes.

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]

Contains phenoxyethanol (or words to that effect).

Contains benzyl alcohol (or words to that effect).

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1 . Formulation 1

Public Summary

Page 1 of

Produced at 12.01.2021 at 12:14:12 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

Dosage Form

Lotion

Route of Administration

Topical

Visual Identification

Active Ingredients

butyl methoxydibenzoylmethane

40 mg/g

homosalate

100 mg/g

octocrylene

80 mg/g

octyl salicylate

50 mg/g

Other Ingredients (Excipients)

alkyl (C12-15) benzoate

Aloe vera

benzyl alcohol

carbomer 941

citric acid

dl-alpha-tocopheryl acetate

hydroxyacetophenone

hyetellose

PEG-15 cocamine

PEG-40 stearate

phenoxyethanol

purified water

silicon dioxide

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 12.01.2021 at 12:14:12 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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