AUSTALIAN GOLD BROAD SPECTRUM SPF 50 SUNSCREEN- titanium dioxide, zinc oxide lotion 
Prime Enterprises Inc.

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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Australian Gold Botanical Sunscreen Broad Spectrum SPF 50

INACTIVE INGREDIENTS

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

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. Keep away from face to avoid breathing it.

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.

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.

Purpose

Sunscreen

Uses

Active Ingredients

Titanium Oxide 4%

Zinc Oxide 4%

Directions

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 Botanical Sunscreen Broad Spectrum SPF 50

Principal Display Label

AUSTALIAN GOLD  BROAD SPECTRUM SPF 50 SUNSCREEN
titanium dioxide, zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0319
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE42.8 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE42.8 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
PANTHENOL (UNII: WV9CM0O67Z)  
FRAGRANCE LAVENDER & CHIA F-153480 (UNII: SXS9CO2TZK)  
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)  
KAKADU PLUM (UNII: 0ZQ1D2FDLI)  
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
Colorwhite (Off White) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58443-0319-4147 mL in 1 BOTTLE; Type 0: Not a Combination Product05/15/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35205/15/2017
Labeler - Prime Enterprises Inc. (101946028)
Registrant - Prime Enterprises Inc. (101946028)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises Inc.101946028pack(58443-0319) , manufacture(58443-0319) , label(58443-0319) , analysis(58443-0319)

Revised: 5/2020
Document Id: a56133c5-fba7-0c1b-e053-2995a90afcf4
Set id: a5612950-ae13-4cdc-e053-2a95a90abb78
Version: 1
Effective Time: 20200511
 
Prime Enterprises Inc.