Label: SUNZONE KIDS SPF 60 BROAD SPECTRUM- octinoxate, octocrylene, octisalate, oxybenzone, avobenzone and homosalate. aerosol, spray

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 December 17, 2012

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  • Active Ingredients

    Octinoxate .......5.0%

    Octocrylene...... 5.0%

    Octisalate..........5.0%

    Oxybenzone..... 6.0%

    Avobenzone......3.0%

    Homosalate.......12.0%

    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 be the sun

    Warnings

    For external use only

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

    Do not use on damaged of broken skin

    When using this product keep away from face to avoid breathing it

    Do not puncture or incinerate. Contents under pressure.

    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

    • Spray liberally and spread evenly by hand 15 minutes before sun exposure
    • Reapply
      • after 80 minutes of swimming or sweating
      • immediately after towel drying
      • at least every 2 hours
    • Hold container 4 to 6 inches from the skin to apply
    • Do not spray directly into face. Spray on hand then apply to face
    • Do not apply in windy conditions
    • Use in a well-ventilated area

    • Sun protection measures. Spending time in the sun increase the risk of skin cancer and early skin again. 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

    Spray liberally and spread evenly by hand 15 minutes before sun exposure.

    Other Information

    • Protect this product from excessive heat and direct sun
    • May stain some fabrics and surfaces

    Inactive Ingredients

    Acrylates Copolymer,  Alcohol Denat.,  Aloe Barbadensis Leaf Extract,  Bisabolol,

    Bis-Hydroxyethoxypropyl Dimethicone, Camellia Oleifera (Japanese Green Tea) Leaf Extract,

    Ethylhexylglycerin, Ethylhexyl Methoxycrylene, Fragrance, Phenoxyethanol, Tocopherol Acetate (Vitamin E)

  • PRINCIPAL DISPLAY PANEL

    Label

  • INGREDIENTS AND APPEARANCE
    SUNZONE KIDS SPF 60  BROAD SPECTRUM
    octinoxate, octocrylene, octisalate, oxybenzone, avobenzone and homosalate. aerosol, spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50021-061
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.75 g  in 155 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE7.75 g  in 155 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE7.75 g  in 155 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE9.30 g  in 155 g
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE4.65 g  in 155 g
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE18.60 g  in 155 g
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    BIS-HYDROXYETHOXYPROPYL DIMETHICONE (50 CST) (UNII: YP714N2H05)  
    DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50021-061-01155 g in 1 CAN
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/16/2012
    Labeler - Empack Spraytech Inc. (252047519)
    Registrant - Empack Spraytech Inc. (252047519)
    Establishment
    NameAddressID/FEIBusiness Operations
    Empack Spraytech Inc252047519manufacture(50021-061)