SUNCLEAR- zinc oxide cream 
Grahams Natural Alternatives Pty Ltd

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Active Ingredients

Zinc Oxide 25%

Purpose

sunscreen

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

Uses

helps prevent sunburn

Directions

apply liberally 15 minutes before sun exposure

reapply:

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

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!

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 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.

image description

SUNCLEAR 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42387-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION25 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42387-001-01150 g in 1 PACKAGE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34709/01/2015
Labeler - Grahams Natural Alternatives Pty Ltd (742235419)
Establishment
NameAddressID/FEIBusiness Operations
Grahams Natural Alternatives Pty Ltd742235419manufacture(42387-001)

Revised: 8/2015
Document Id: be2d3046-d640-4da9-9cba-2df7d4b7f0e8
Set id: 6dc568bf-88b7-42e1-bdd0-835ec65aaa9a
Version: 1
Effective Time: 20150826
 
Grahams Natural Alternatives Pty Ltd