AUSTRALIAN GOLD HELLO KITTY MINERAL FACES SUNSCREEN- titanium dioxide, zinc oxide lotion

Australian Gold by

Drug Labeling and Warnings

Australian Gold by is a Otc medication manufactured, distributed, or labeled by Prime Enterprises Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Titanium Dioxide 4.5%

Zinc Oxide 4%

Purpose

Sunscreen

Uses

• helps prevent sunburn
• if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

WARNINGS

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

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

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
• Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with Broad Spectrum SPF of 15 or higher and other sun protection measures including:
• limit time in the sun, especially from 10 a.m. – 2 p.m.
• wear long-sleeve shirts, pants, hats, and sunglasses
• children under 6 months: Ask a doctor

INACTIVE INGREDIENT

Acrylates/C12-22 Alkyl Methacrylate Copolymer, Aluminum Hydroxide, Artemisia Princeps (Yomogi) Extract, Buddleja Davidii (Butterfly Bush) Extract, C12-15 Alkyl Benzoate, Ceteareth-20, Cetyl Alcohol, Dibutly Adipate, Dimethicone, Glycerin, Hexyl Laurate, Magnesium Aluminum Silicate, Methylcellulose, Methylisothiazolinone, PEG-12 Dimethicone, Phenoxyethanol, Polyglyceryl-3 Distearate, Propylene Glycol, Stearic Acid, Stearyl Alcohol, Triethoxycaprylylsilane, Trimethylsiloxysilicate, Water (Aqua), Xanthan Gum, may contain Citric Acid, may contain Sodium Hydroxide

Other Information

• protect this product from excessive heat and direct sun

Questions or Comments?

Call toll free 1-855-LIV-GOLD (548-4653)

Australian Gold Hello Kitty Mineral Faces Sunscreen

INGREDIENTS AND APPEARANCE

AUSTRALIAN GOLD  HELLO KITTY MINERAL FACES SUNSCREEN
titanium dioxide, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58443-0219
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	41.6 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	46.8 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
POLYGLYCERYL-3 DISTEARATE (UNII: ZI1LK470XV)
XANTHAN GUM (UNII: TTV12P4NEE)
BUTYL ACRYLATE/C16-C20 ALKYL METHACRYLATE/METHACRYLIC ACID/METHYL METHACRYLATE COPOLYMER (UNII: 7K68DGG29P)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CETEARETH-22 (UNII: 28VZG1E234)
CETYL ALCOHOL (UNII: 936JST6JCN)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
DIMETHICONE (UNII: 92RU3N3Y1O)
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2)
GLYCERIN (UNII: PDC6A3C0OX)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
METHYLCELLULOSE (100 CPS) (UNII: 4GFU244C4J)
WATER (UNII: 059QF0KO0R)
PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
BUDDLEJA DAVIDII LEAF (UNII: X380815D32)
ARTEMISIA PRINCEPS LEAF OIL (UNII: F9S1101A2V)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
DIBUTYL ADIPATE (UNII: F4K100DXP3)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58443-0219-3	88 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/23/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	12/23/2013

Labeler - Prime Enterprises Inc. (101946028)

Registrant - Prime Enterprises Inc. (101946028)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Enterprises Inc.		101946028	pack(58443-0219) , manufacture(58443-0219) , label(58443-0219) , analysis(58443-0219)