SUNCLEAR- zinc oxide cream

SunClear by

Drug Labeling and Warnings

SunClear by is a Otc medication manufactured, distributed, or labeled by Grahams Natural Alternatives Pty Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients

Zinc Oxide 25%

PURPOSE

Purpose

sunscreen

KEEP OUT OF REACH OF CHILDREN

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

INDICATIONS & USAGE

Uses

helps prevent sunburn

DOSAGE & 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

WARNINGS

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

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!

QUESTIONS

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

INACTIVE INGREDIENT

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SUNCLEAR 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42387-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	25 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9)
ROSA CANINA SEED (UNII: 4503R1M9UT)
VITIS VINIFERA SEED (UNII: C34U15ICXA)
OLIVE OIL (UNII: 6UYK2W1W1E)
SESAME OIL (UNII: QX10HYY4QV)
SHEA BUTTER (UNII: K49155WL9Y)
TOCOPHEROL (UNII: R0ZB2556P8)
VITAMIN A (UNII: 81G40H8B0T)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
COCONUT OIL (UNII: Q9L0O73W7L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42387-001-01	150 g in 1 PACKAGE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	09/01/2015

Labeler - Grahams Natural Alternatives Pty Ltd (742235419)

Establishment
Name	Address	ID/FEI	Business Operations
Grahams Natural Alternatives Pty Ltd		742235419	manufacture(42387-001)