SUNZONE SPF-60 BROAD SPECTRUM (AVOBENZONE AND OCTINOXATE) LOTION [EMPACK SPRAYTECH INC.]

SUNZONE SPF-60 BROAD SPECTRUM (AVOBENZONE AND OCTINOXATE) LOTION [EMPACK SPRAYTECH INC.]
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NDC 50021-234-01, 50021-234-02, 50021-234-03, 50021-234-04, 50021-234-05
Set ID 9ee30b14-f196-4ec6-b307-92d731539fc1
Category HUMAN OTC DRUG LABEL
Packager Empack Spraytech Inc.
Generic Name
Product Class
Product Number
Application Number PART352
  • Active Ingredients

    Avobenzone......3%

    Octinoxate........4%

    Purpose

    Sunscreen

    Uses

    Helps prevent sunburn

    Warnings

    For external use only

    When using the product do not get into eyes. If contact occurs, rinse thoroughly with water

    Stop use and ask a doctor if irritaion occurs

    Keep out of reach of children

    If product is swallowed, get medical help or contact a Posion Control Center right away

    Directions
    • Apply liberally and spread evenly 15 minutes before sun exposure
    • Reapply after 80 minutes of swimmin or sweating
    • immediately after swimming, towel drying
    • At least every 2 hours

    SUN PROTECTION MEASURES. Spending time in the sun increases your risk of skin cancer and early skin damage. To decrease this risk, regularly use a sunscreen with broad spectrum SPF 15 or higher and other sun protection measures including;

    • Limit time in the sun, especially from 10 a.m-2p.m
    • Wear long-sleeve shirts, pants, hats and sunglasses

    Children under 6 months: ASK A DOCTOR

    Inactive Ingredients

    Acrylates Copolymer, Aloe Barbadensis Leaf Extract, Aminomethyl Propanol, Ammonium Acryloyldimethyltaurate/VP Copolymer, C12-15 Alkyl Benzoate, Camellia Oleifera (Japanese Green Tea) Leaf Extract, Carthamus Tinctorius (safflower) Oleosomes, dl-alpha Tocopheryl acetate, Ethylhexylglycerin, fragrance, glycerin, Octyldodecyl Citrate Crosspolymer, Phenoxyethanol, Phenyl Trimethicone, Water

    Information

    Protect this product from excessive heat and direct sun

    May stain some fabrics or surfaces

    Question or Comments

    Call toll free 1-866-923-2665

    Empack Spraytech Inc.

    98 walker Drive, Brampton, Ontario

    L6T 4H6

    www.sunzone.ca

    Made in Canada

    Please Recycle

  • PRINCIPAL DISPLAY PANEL

    Labels

  • INGREDIENTS AND APPEARANCE
    SUNZONE SPF-60  BROAD SPECTRUM
    avobenzone and octinoxate lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50021-234
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE9.36 g  in 234 g
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE7.02 g  in 234 g
    Inactive Ingredients
    Ingredient NameStrength
    CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    TRIOCTYLDODECYL CITRATE (UNII: 35X8CT063R)  
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50021-234-01234 g in 1 TUBE
    2NDC:50021-234-02234 g in 1 TUBE
    3NDC:50021-234-03234 g in 1 TUBE
    4NDC:50021-234-04234 g in 1 TUBE
    5NDC:50021-234-05234 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/13/2012
    Labeler - Empack Spraytech Inc. (252047519)
    Registrant - Empack Spraytech Inc. (252047519)
    Establishment
    NameAddressID/FEIBusiness Operations
    Empack Spraytech Inc.252047519manufacture(50021-234)

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