Active Ingredients

Titanium Oxide 4%

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 ine the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF valvue of 15 or higher and other sun protecion measures including:
limit time in the sun, especially from 10am-2pm
wear long-sleeve shirts, pants, hats, and sunglasses
children under 6 months: Ask a doctor

INACTIVE INGREDIENTS

Alumina, Cyclopentasiloxane, Butyrospermum Parkii (Shea) Butter, Caprylyl Glycol, Cetyl PEG/PPG-10/1 Dimethicone, Cyclopentasiloxane, Dimethicone Crosspolymer, Disodium EDTA, Disteardimonium Hectorite, Eucalyptus Globulus (Eucalyptus) Leaf Extract, Glycerin,Hexyl Laurate, Iron Oxides, Panthenol, Peg-10 Dimethicone, Phenoxyethanol, Polyglyceryl-4 Isostearate,Polymethylsilsesquioxane, Porphyra Umbilicalis Extract, Squalane, Stearic Acid, Tocopheryl Acetate, Triethoxycaprylylsilane, Water

Other Information

Protect this product from excessive heat and direct sun
May stain some fabrics or surfaces

Questions or Comments?

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

Australian Gold Botanical Sunscreen Broad Spectrum SPF 50

Principle Display Label

AUSTALIAN GOLD BROAD SPECTRUM SPF 50 SUNSCREEN
titanium dioxide, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58443-0592
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	42.16 g in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	42.16 g in 1 mL

Ingredient Name	Strength
Inactive Ingredients
FERRIC OXIDE RED (UNII: 1K09F3G675)
PANTHENOL (UNII: WV9CM0O67Z)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
ALUMINUM OXIDE (UNII: LMI26O6933)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
STEARIC ACID (UNII: 4ELV7Z65AP)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SQUALANE (UNII: GW89575KF9)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
PORPHYRA UMBILICALIS (UNII: 14AN0J70WO)
GLYCERIN (UNII: PDC6A3C0OX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)
EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)
SHEA BUTTER (UNII: K49155WL9Y)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
HEXYL LAURATE (UNII: 4CG9F9W01Q)

Product Characteristics
Color	white (Off White)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:58443-0592-3	88 mL in 1 TUBE; Type 0: Not a Combination Product	10/13/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	M020	10/13/2016

Labeler - Prime Enterprises Inc. (101946028)

Registrant - Prime Enterprises Inc. (101946028)

Name	Address	ID/FEI	Business Operations
Establishment
Prime Enterprises Inc.		101946028	pack(58443-0592) , manufacture(58443-0592) , label(58443-0592) , analysis(58443-0592)