Dermalogica Prisma Protect SPF30

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

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Active ingredient:
butyl methoxydibenzoylmethane,homosalate,octocrylene,octyl salicylate
Available from:
Dermalogica Pty Ltd
Authorization status:
Listed
Authorization number:
352431

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Public Summary

Summary for ARTG Entry:

352431

Dermalogica Prisma Protect SPF30

ARTG entry for

Medicine Listed

Sponsor

Dermalogica Pty Ltd

Postal Address

111 Chandos Street, CROWS NEST, NSW, 2065

Australia

ARTG Start Date

4/01/2021

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 . Dermalogica Prisma Protect SPF30

Product Type

Single Medicine Product

Effective Date

4/01/2021

Permitted Indications

May assist in preventing some skin cancers (sunscreen)

May reduce the risk of some skin cancers (sunscreen)

SPF 30 Broad spectrum 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.

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.

Standard Indications

No Standard Indications included on Record

Specific Indications

No Specific Indications included on Record

Warnings

(If the medicine contains one sorbate) Contains [insert name of sorbate] OR (if medicine contains two or more sorbates) Contains sorbates [or words to that

effect].

(If medicine contains one benzoate) Contains [insert name of benzoate] Or (If medicine contains two or more benzoates) Contains benzoates [or words to

that effect].

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]

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Components

Public Summary

Page 1 of

Produced at 11.01.2021 at 07:32:38 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

1 . Formulation 1

Dosage Form

Lotion

Route of Administration

Topical

Visual Identification

Active Ingredients

butyl methoxydibenzoylmethane

30 mg/g

homosalate

100 mg/g

octocrylene

100 mg/g

octyl salicylate

50 mg/g

Other Ingredients (Excipients)

1,2-hexanediol

1,3-butylene glycol

acrylates/C10-30 alkyl acrylate crosspolymer

alkyl (C12-15) benzoate

arachidyl alcohol

arachidyl glucoside

behenyl alcohol

bisabolol

butyloctyl salicylate

Camellia sinensis

caprylyl glycol

Chlorella vulgaris

citric acid

colloidal anhydrous silica

dimethicone crosspolymer

dl-alpha-tocopheryl acetate

ethylhexylglycerin

glycerol

glyceryl monostearate

limonene

medium chain triglycerides

PEG-100 stearate

pentylene glycol

polyglyceryl-2 distearate

polyvinyl alcohol

potassium cetyl phosphate

potassium sorbate

propanediol

purified water

PVP/eicosene copolymer

saccharide isomerate

sodium benzoate

sodium citrate

sodium hydroxide

trisodium ethylenediamine disuccinate

xanthan gum

Zingiber officinale

© 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 07:32:38 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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