Label: AUSTRALIAN GOLD BROAD SPECTRUM SPF 50 SUNSCREEN- titanium dioxide, zinc oxide lotion

  • NDC Code(s): 58443-0552-3
  • Packager: Prime Enterprises Inc.
  • 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 April 29, 2022

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  • 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 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, 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, Terminalia Ferdinandiana (Kakadu Plum) Fruit Extract, Tocopheryl Acetate, Triethoxycaprylylsilane, Water

  • Other Information

    • Protect this product from excesive heat and direct sun
    • May stain some frabics or surfaces
  • Questions or Comments?

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

  • Australian Gold Botanical Sunscreen Tinted Face 50

    Principle Display Label

  • INGREDIENTS AND APPEARANCE
    AUSTRALIAN GOLD  BROAD SPECTRUM SPF 50 SUNSCREEN
    titanium dioxide, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0552
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE42.4 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE42.4 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)  
    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
    Colorbrown (Dark Nude) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58443-0552-388 mL in 1 BOTTLE; Type 0: Not a Combination Product03/04/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35203/04/2022
    Labeler - Prime Enterprises Inc. (101946028)
    Registrant - Prime Enterprises Inc. (101946028)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Enterprises Inc.101946028pack(58443-0552) , manufacture(58443-0552) , label(58443-0552) , analysis(58443-0552)
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