SPL v1
SPL
SPL Set ID 6dc568bf-88b7-42e1-bdd0-835ec65aaa9a
Route
TOPICAL
Published
Effective Date 2015-09-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Cation (25 g)
Inactive Ingredients
Caprylic/capric/lauric Triglyceride Rosa Canina Seed Vitis Vinifera Seed Olive Oil Sesame Oil Shea Butter Tocopherol Vitamin A Phenoxyethanol Coconut Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2015-09-01

Description

Active Ingredients Zinc Oxide 25%


Medication Information

Warnings and Precautions

Warnings

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

For external use only

Do not use on damaged or broken skin

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs

Indications and Usage

Uses

helps prevent sunburn

Dosage and Administration

Directions

apply liberally 15 minutes before sun exposure

reapply:

  • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours
  • children under 6 months: ask a doctor
Description

Reef Friendly

Non Nano

SunClear SPF 30 sunscreen

UVA & UVB

Broad Spectrum Protection

Very Water Resistant

80 minutes

Sensitive Skin Formula

Thank you for choosing our premium eco friendly Sunscreen.

It is tried and tested under the harsh conditions of the Australian sun! Especially formulated for those with sensitive skin and all skin types.

SunClear Natural sunscreen is the perfect sunblock that will not harm you, the water, the earth or the coral reefs!

Section 50565-1

Keep out of the reach of children. If swallowed, get medical help or contact a poison control center immediately.

Section 51727-6

Inactive Ingredients

caprylic/capric trilglyceride, rosa canina seed (rose hip) oil, vitis vinifera seed (grape seed) oil, olea europaea (extra virgin olive) oil, sesamum indicum (sesame) oil, butyspermum parkii (shea) butter, tocopherol (natural vitamin E), provitamin A, phenoxyethanol, coconut oil.

Section 51945-4

Section 53413-1

Other Information

protect this product from excessive heat and direct sun

Questions   www.itchy.net.au

Made in Australia

Grahams Natural Alternatives Pty Ltd

7 Palings Court, Nerang, QLD 4211 Australia

Section 55105-1

Purpose

sunscreen

Section 55106-9

Active Ingredients

Zinc Oxide 25%


Structured Label Content

Indications and Usage (34067-9)

Uses

helps prevent sunburn

Dosage and Administration (34068-7)

Directions

apply liberally 15 minutes before sun exposure

reapply:

  • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours
  • children under 6 months: ask a doctor
Warnings and Precautions (34071-1)

Warnings

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

For external use only

Do not use on damaged or broken skin

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs

Description (34089-3)

Reef Friendly

Non Nano

SunClear SPF 30 sunscreen

UVA & UVB

Broad Spectrum Protection

Very Water Resistant

80 minutes

Sensitive Skin Formula

Thank you for choosing our premium eco friendly Sunscreen.

It is tried and tested under the harsh conditions of the Australian sun! Especially formulated for those with sensitive skin and all skin types.

SunClear Natural sunscreen is the perfect sunblock that will not harm you, the water, the earth or the coral reefs!

Section 50565-1 (50565-1)

Keep out of the reach of children. If swallowed, get medical help or contact a poison control center immediately.

Section 51727-6 (51727-6)

Inactive Ingredients

caprylic/capric trilglyceride, rosa canina seed (rose hip) oil, vitis vinifera seed (grape seed) oil, olea europaea (extra virgin olive) oil, sesamum indicum (sesame) oil, butyspermum parkii (shea) butter, tocopherol (natural vitamin E), provitamin A, phenoxyethanol, coconut oil.

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Other Information

protect this product from excessive heat and direct sun

Questions   www.itchy.net.au

Made in Australia

Grahams Natural Alternatives Pty Ltd

7 Palings Court, Nerang, QLD 4211 Australia

Section 55105-1 (55105-1)

Purpose

sunscreen

Section 55106-9 (55106-9)

Active Ingredients

Zinc Oxide 25%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)