Label: SUNZONE FAMILY SPF 30 BROAD SPECTRUM- octinoxate and avobenzone lotion 

  • Label RSS
  • NDC Code(s): 50021-235-01, 50021-235-02, 50021-235-03, 50021-235-04, view more
    50021-235-05
  • Packager: Empack Spraytech Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 11/12

If you are a consumer or patient please visit this version.

  • Active Ingredients

    Octinoxate 2.0%

    Avobenzone 0.75%

    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 irritation or rash 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 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 Leaft Extract, Aminomethyl Propanol, Ammonium Acryloldimethyltaurate/VP Copolymer, C12-15 Alkyl Benzonate, Camellia Oleifera (Japanese Green Tea) Leaf Extract, Carthamus Tinctorius (Safflower) Oleosomes, Ethylhexylglycerin, Fragrance, Glycerin, Phenoxyethanol, Phenyl Trimethicone, Tocopheryl acetate (Vitamin E), Water

    Protect this product from excessive heat and direct sun

    May stain some fabrics or surfaces

    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

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  • INGREDIENTS AND APPEARANCE
    SUNZONE FAMILY SPF 30  BROAD SPECTRUM
    octinoxate and avobenzone lotion
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:50021-235
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OCTINOXATE (OCTINOXATE) OCTINOXATE 4.70 g  in 235 g
    AVOBENZONE (AVOBENZONE) AVOBENZONE 1.76 g  in 235 g
    Inactive Ingredients
    Ingredient Name Strength
    CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES  
    .ALPHA.-TOCOPHEROL ACETATE, DL-  
    PHENYL TRIMETHICONE  
    WATER  
    ALOE VERA LEAF  
    CAMELLIA OLEIFERA LEAF  
    GLYCERIN  
    PHENOXYETHANOL  
    ETHYLHEXYLGLYCERIN  
    AMINOMETHYLPROPANOL  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50021-235-01 235 g in 1 TUBE
    2 NDC:50021-235-02 235 g in 1 TUBE
    3 NDC:50021-235-03 235 g in 1 TUBE
    4 NDC:50021-235-04 235 g in 1 TUBE
    5 NDC:50021-235-05 235 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 11/12/2012
    Labeler - Empack Spraytech Inc (252047519)
    Registrant - Empack Spraytech Inc (252047519)
    Establishment
    Name Address ID/FEI Business Operations
    Empack Spraytech Inc 252047519 manufacture(50021-235)
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