Label: AUSTRALIAN GOLD BROAD SPECTRUM SPF 30 WITH INVISIDRY TECHNOLOGY- avovenzone, homosalate, octisalate, octocrylene, and oxybenzone aerosol, 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

    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. Keep away from face to avoid breathing it. Content under pressure - do not puncture or incinerate. Do not store at temperatures above 120°F.

    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
    • Children under 6 months: Ask a doctor
    • Hold container 4 to 6 inches from the skin to apply
    • Do not spray directly into face. Spray 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
  • Inactive Ingredients

    Acacia Senegal Flower/Stem Extract, Blue 1 (Cl 42090), Camellia Sinensis (Green Tea) Leaf Extract, Coddea Arabica (Kona Coffee) Seed Extract, Diethylhexyl 2,6-Naphthalate, Fragrance (Parfum), Glycerin, Polyester-8, Propylene Glycol, Red-40 (Cl 16035), SD Alcohol 40-B (Alcohol Denat), Terminalia Ferdinandiana (Kakadu Plum) Fruit Extract, TocopherylAcetate, VA/Butyl Maleate/Isobomyl Acrylate Copolymer, Water (Aqua), Yellow 5 (Cl 19140)

  • Other information

    • protect this product from excesive heat and direct sun
    • avoid spraying on fabrics, could cause discoloration
  • Questions or Comments?

    Call toll free 1-800-LIV-GOLD (548-4653)

  • PRINCIPAL DISPLAY PANEL - 177 mL Can Label

    PRINCIPAL DISPLAY PANEL - 177 mL Can Label

    Exotic Blend

    #1 Fragrance

    Sheer Coverage

    30

    Continuous Spray

    Sunscreen

    Invisidry™ Technology

    Kona Coffee

    Infused Bronzers

    Broad Spectrum SPF 30

    Water Resistant

    (80 Minutes)

    Autralian

    G old®

    177 mL / 6Fl. Oz

  • INGREDIENTS AND APPEARANCE
    AUSTRALIAN GOLD  BROAD SPECTRUM SPF 30 WITH INVISIDRY TECHNOLOGY
    avovenzone, homosalate, octisalate, octocrylene, and oxybenzone aerosol, spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13630-0086
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE25.8 mg  in 1 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE64.5 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE43 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE23.7 mg  in 1 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE17.2 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM)  
    POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    DIBUTYL MALEATE (UNII: 4X371TMK9K)  
    ISOBORNYL ACRYLATE (UNII: IX0PRH184P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ACACIA SENEGAL FLOWER (UNII: 72P931MTC2)  
    KAKADU PLUM (UNII: 0ZQ1D2FDLI)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    COFFEA ARABICA SEED, ROASTED (UNII: 9H58JRT35E)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColoryellowScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13630-0086-4177 mL in 1 CAN; Type 0: Not a Combination Product10/22/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35210/22/2012
    Labeler - Prime Packaging, Inc. (805987059)
    Registrant - Prime Packaging, Inc. (805987059)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Enterprises, Inc.101946028manufacture(13630-0086) , analysis(13630-0086)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Packaging, Inc.805987059label(13630-0086) , pack(13630-0086)
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