Label: AUSTRALIAN GOLD BROAD SPECTRUM SPF 8- avobenzone, octocrylene, and oxybenzone lotion

  • 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 January 17, 2020

If you are a consumer or patient please visit this version.

View All Sections
  • Active ingredients

    Avobenzone 0.5 %, Octocrylene 2 %, and Oxybenzone 1.5 %

  • PURPOSE

    Purpose

    Sunscreen

  • Uses

    • helps prevent sunburn
  • Warnings

    Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

    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
    • Children under 6 months: Ask a doctor
  • Inactive Ingredients

    Acrylates/C10-30 Alkyl Acrylate Crosspolymer, BHT (Butylated Hydroxytoluene), Butylphthalimide, Cetyl Alcohol, Disodium EDTA, Fragrance (Parfum), Glycyrrhiza Glabra (Licorice) Root Extract, Isopropylphthalimide, Methylisothiazolinone, Methylparaben, Phenyl Trimethicone, Polyethylene, Polysilicone-15, Potassium Cetyl Phosphate, Potassium Hydroxide, Propylene Glycol, Propylparaben, Silica, Stearyl Alcohol, Styrene/Acrylates Copolymer, Water (Aqua)

  • Other information

    • protect this product from excesive heat and direct sun
  • QUESTIONS

    Questions or Comments?

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

  • PRINCIPAL DISPLAY PANEL - 177 mL  Tube Label

    PRINCIPAL DISPLAY PANEL - 177 mL Tube Label


    EXOTIC BLEND

    #1 Fragrance

    Sheer Coverage

    8

    Lotion Sunscreen

    InvisiDry Technology

    Clean and Hydrating

    Broad Spectrum SPF 8

    WATER RESISTANT

    (80 MINUTES)

    Australian

    Gold

    177 mL / 6 Fl. Oz

  • INGREDIENTS AND APPEARANCE
    AUSTRALIAN GOLD  BROAD SPECTRUM SPF 8
    avobenzone, octocrylene, and oxybenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0029
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE4.9 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE19.4 mg  in 1 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE14.6 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    3-BUTYLPHTHALIDE (UNII: 822Q956KGM)  
    ISOPROPYLPHTHALIMIDE (UNII: 1J1MM83329)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    POLYSILICONE-15 (UNII: F8DRP5BB29)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    GLYCYRRHIZA GLABRA LEAF (UNII: GH32M797Y9)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    STYRENE (UNII: 44LJ2U959V)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58443-0029-4177 mL in 1 TUBE; Type 0: Not a Combination Product11/18/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35211/18/2013
    Labeler - Prime Enterprises, Inc. (101946028)
    Registrant - Prime Enterprises, Inc. (101946028)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Enterprises, Inc.101946028label(58443-0029) , pack(58443-0029) , manufacture(58443-0029) , analysis(58443-0029)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!