AUSTRALIAN 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 Tinted Face Medium Broad Spectrum SPF 50 (non-Kakadu)

Active Ingredients

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

Other Information

  • Protect this product from excesive 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 Tinted Face 50

Principle Display Label

AUSTRALIAN GOLD  BROAD SPECTRUM SPF 50 SUNSCREEN
titanium dioxide, zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0563
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE41.6 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE41.6 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
PANTHENOL (UNII: WV9CM0O67Z)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
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
Colorbrown (Dark Nude) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58443-0563-388 mL in 1 BOTTLE; Type 0: Not a Combination Product07/08/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM02007/08/2022
Labeler - Prime Enterprises Inc. (101946028)
Registrant - Prime Enterprises Inc. (101946028)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises Inc.101946028pack(58443-0563) , manufacture(58443-0563) , label(58443-0563) , analysis(58443-0563)

Revised: 8/2022
Document Id: e779fc98-9854-25b4-e053-2995a90a3926
Set id: e77a814b-bf9c-7eec-e053-2995a90a023a
Version: 1
Effective Time: 20220830
 
Prime Enterprises Inc.