SUNZONE FAMILY SPF 15 BROAD SPECTRUM (OCTINOXATE AND AVOBENZONE) LOTION [EMPACK SPRAYTECH INC.]

SUNZONE FAMILY SPF 15 BROAD SPECTRUM (OCTINOXATE AND AVOBENZONE) LOTION [EMPACK SPRAYTECH INC.]
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NDC 50021-016-01
Set ID 0ce4e39a-52df-4b3c-8313-ae5c27f3701c
Category HUMAN OTC DRUG LABEL
Packager Empack Spraytech Inc.
Generic Name
Product Class
Product Number
Application Number PART352
  • Active Ingredient

    Avobenzone........0.50%

    Octinoxate..........1.0%

    Purpose

    Sunscreen

    Uses

    Helps prevent sunburn

    Warnings

    For external use only

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

    Stop use and ask a doctor if irritaion or rash occurs

    Keep out of reach of children

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

    Directions
    • Apply liberally and spread envenly 15 minutes before sun exposure
    • Reapply after 80 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 hours
    • Use in a well-ventilated area

    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

    prtection measures including:

    • Limit time in the sun, especially from 10 am - 2 pm
    • 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, Ethylhexylglycerin, Fragrance, Glycerin, Phenoxyethanol, Phenyl Trimethicone, Tocopheryl acetate(Vitamin E), Water

    Information

    Protect this product formexcessive heat and direct sun

    May stain some fabrics or surfaces

    Question and 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

    SunZone Family Sunscreen Lotion

    SPF 15 Broad Spectrum UVA/UVB Protection

    Water Resistant (80 Minutes)

    Ligh, Non-greasy

    Patented Oleosome Technology derived from Plant Seeds

    8fl oz(237mL)

    image description

  • INGREDIENTS AND APPEARANCE
    SUNZONE FAMILY SPF 15  BROAD SPECTRUM
    octinoxate and avobenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50021-016
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.35 g  in 235 g
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1.18 g  in 235 g
    Inactive Ingredients
    Ingredient NameStrength
    CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)  
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50021-016-01235 g in 1 TUBE
    2NDC:50021-016-01235 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/14/2012
    Labeler - Empack Spraytech Inc. (252047519)
    Registrant - Empack Spraytech Inc. (252047519)
    Establishment
    NameAddressID/FEIBusiness Operations
    Empack Spraytech Inc.252047519manufacture(50021-016)

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