Label: SUNCLEAR- zinc oxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 42387-001-01 - Packager: Grahams Natural Alternatives Pty Ltd
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated August 26, 2015
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
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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
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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
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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
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INGREDIENTS AND APPEARANCE
SUNCLEAR
zinc oxide creamProduct 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)
