Label: AUSTRALIAN GOLD BROAD SPECTRUM 30- avobenzone, homoslate, octisalate ,octocrylene and oxybenzone spray

  • 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

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  • Active ingredients

    Avobenzone 3 %, Homosalate 7.5 %, Octisalate 5 %, Octocrylene 2.75 % and Oxybenzone 2 %

  • PURPOSE

    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 broken or damaged skin

    When using this product keep out of eyes. Rinse with water to remove. Keep away from face to avoid breathing it. Contents under pressure - do not puncture or incinirate. Do not store at temperatures above 120 0F

    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.

    Flammable: Do not use near heat, flame or while smoking

  • Directions

    • spray liberally and spread evenly by hand 15 minutes before sun exposure
    • hold container 4 to 6 inches from the skin to apply
    • do not spray directly into face. Spray on hands then apply to face
    • do not apply in windy conditions
    • use in well-ventilated areas
    • reapply:
      • after 80 minutes of swimming or sweating
      • immediately after towel drying
      • at least every 2 hours

    • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other sun protection measures including:

      • limit time in the sun, especially from 10 a.m. – 2 p.m.
      • wear long-sleeve shirts, pants, hats, and sunglasses
    • Children under 6 months: Ask a doctor

  • Inactive Ingredients

    Artemisia Princeps (Yomogi) Extract, Buddleja Davidii (Butterfly Bush) Extract, C12-15 Alkyl Benzoate, Diethylhexyl 2,6-Naphthalate, Diisopropyl Adipate, Fragrance (Parfum), Octyldodecyl Citrate Crosspolymer, Phenethyl Benzoate, Polyester-8, Propylene Glycol, SD Alcohol 40-B (Alcohol Denat.), Tocopheryl Acetate, Tridecyl Neopentanoate, VA/Butyl Maleate/Isobornyl Acrylate Copolymer

  • Other information

    • protect this product from excesive heat and direct sun
    • avoid spraying on fabrics - could cause discoloration
  • QUESTIONS

    Questions or Comments?

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

  • PRINCIPAL DISPLAY PANEL - 150 mL Can Label

    PRINCIPAL DISPLAY PANEL - 150 mL Can Label

    Australian Gold

    HELLO

    KITTY

    Wet/Dry Skin Formula

    Body Mist Sunscreen

    Krazy Kiwi

    30

    BROAD SPECTRUM SPF 30

    Water Resistant (80 minutes)

    5 FL OZ (150mL)

  • INGREDIENTS AND APPEARANCE
    AUSTRALIAN GOLD  BROAD SPECTRUM 30
    avobenzone, homoslate, octisalate ,octocrylene and oxybenzone spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13630-0071
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE26.6 mg  in 1 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE66.5 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE44.4 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE24.4 mg  in 1 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE17.7 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM)  
    DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)  
    PHENETHYL BENZOATE (UNII: 0C143929GK)  
    POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)  
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TRIDECYL NEOPENTANOATE (UNII: 3Z8H1DA7J5)  
    DIBUTYL MALEATE (UNII: 4X371TMK9K)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ARTEMISIA PRINCEPS LEAF (UNII: SY077EW02G)  
    BUDDLEJA DAVIDII LEAF (UNII: X380815D32)  
    TRIOCTYLDODECYL CITRATE (UNII: 35X8CT063R)  
    Product Characteristics
    ColoryellowScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13630-0071-3150 mL in 1 CAN; Type 0: Not a Combination Product12/19/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35212/19/2013
    Labeler - Prime Packaging, Inc. (805987059)
    Registrant - Prime Packaging, Inc. (805987059)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Enterprises, Inc.101946028manufacture(13630-0071) , analysis(13630-0071)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Packaging, Inc.805987059label(13630-0071) , pack(13630-0071)
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