Label: AUSTRALIAN GOLD SPF 15- avobenzone, octisalate, octocrylene spray

  • NDC Code(s): 58443-0381-3
  • 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 January 6, 2021

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  • Active Ingredients

    Avobenzone 2%

    Octisalate 5%

    Octocrylene 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 away form face to avoid breathing it. 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

    shake well before use

    apply liberally 15 minutes before sun exposure and rub into skin

    hold container 4 to 6 inches from the skin to apply

    do not spray directly into face. Spray on hands then apply to face

    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 a 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

  • Other information

    Protect this product form excessive heat and direct sun

    May stain some fabrics or surfaces

  • Questions or comments?

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

  • Australian Gold Instant Bronzer Spray Gel Sunscreen SPF15

    Principal Display Panel

  • INGREDIENTS AND APPEARANCE
    AUSTRALIAN GOLD  SPF 15
    avobenzone, octisalate, octocrylene spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0381
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE19.4 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE48.5 mg  in 1 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE19.4 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYLPHTHALIMIDE (UNII: 1J1MM83329)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    N-BUTYLPHTHALIMIDE (UNII: 5TH1DKT35E)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    KAKADU PLUM (UNII: 0ZQ1D2FDLI)  
    CARAMEL (UNII: T9D99G2B1R)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    Product Characteristics
    Colorbrown (Caramel) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58443-0381-3100 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product10/08/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35210/08/2019
    Labeler - Prime Enterprises, Inc. (101946028)
    Registrant - Prime Enterprises, Inc. (101946028)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Enterprises, Inc.101946028manufacture(58443-0381) , label(58443-0381) , analysis(58443-0381) , pack(58443-0381)
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