Label: AUSTRALIAN GOLD KIDS SPF 50 SUNSCREEN- homosalate, octinoxate, octisalate and titanium dioxide 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

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  • Active Ingredients

    Homosalate 10%

    Octinoxate 7.5%

    Octisalate 5%

    Titanium Dioxide 2.4%

  • 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 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 INGREDIENT

    Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, C12-15 Alkyl Benzoate, Camellia Sinensis (Green Tea) Leaf Extract, Caprylhydroxamic Acid, Caprylyl Glycol, Carbomer, Dimethicone, Disodium EDTA, Fragrance, Glycerin, Helianthus Annuus (Sunflower) Seed Oil, Hydroxypropyl Methylcellulose, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Olea Europaea (Olive) Fruit Oil, Polyethylene, Polyhydroxystearic acid, Polysorbate 20, Propylene Glycol, Sodium Hydroxide, Sorbitan Oleate, Styrene/Acrylates Copolymer, Terminalia Ferdinandiana (Kakadu Plum) Fruit Extract, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate, Water

  • Other Information

    • protect this product from excesive heat and direct sun
  • Questions or Comments?

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

  • Australian Gold Kids SPF 50 Lotion Sunscreen

    Principle Display Panel

  • INGREDIENTS AND APPEARANCE
    AUSTRALIAN GOLD  KIDS SPF 50 SUNSCREEN
    homosalate, octinoxate, octisalate and titanium dioxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0200
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE24.5 mg  in 1 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE102 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE51 mg  in 1 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE76.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    (C10-C30)ALKYL METHACRYLATE ESTER (UNII: XH2FQZ38D8)  
    KAKADU PLUM (UNII: 0ZQ1D2FDLI)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    METHACRYLATE/METHOXY PEG-10 MALEATE/STYRENE COPOLYMER (UNII: 39DK5WQ2PR)  
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58443-0200-4237 mL in 1 BOTTLE; Type 0: Not a Combination Product11/02/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35211/02/2015
    Labeler - Prime Enterprises Inc. (101946028)
    Registrant - Prime Enterprises Inc. (101946028)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Enterprises Inc.101946028pack(58443-0200) , manufacture(58443-0200) , label(58443-0200)
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