BADGER SPF 35 ALL SEASON FACE (ZINC OXIDE) STICK [NORWOOD PACKAGING LTD.]

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BADGER SPF 35 ALL SEASON FACE (ZINC OXIDE) STICK [NORWOOD PACKAGING LTD.]
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NDC 55143-101-01
Set ID f181011f-bb48-4704-96c9-5899adc6a75b
Category HUMAN OTC DRUG LABEL
Packager Norwood Packaging Ltd.
Generic Name
Product Class
Product Number
Application Number PART352
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Non-Nano Uncoated Zinc Oxide 22.5%

  • 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. Stop and ask a doctor if rash occurs.

    When using this product keep out of eyes. Rinse with water to remove.

    Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • For full protection, apply liberally (2mg/cm2 of skin) to exposed skin 15 minutes before sun exposure, then rub in to reduce whitening effect.

    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 value of 15 or higher and other sun protection measures including:
      • Limit time in the sun, especially from 10am-2pm
      • Wear long-sleeved shirts, pants, hats, and sunglasses
    • For children under 6 months of age: ask a doctor.
  • Ingredients

    1Olea Europaea (Extra Virgin Olive) Oil, 1Cera Alba (Beeswax), 1Theobroma Cacao (Cocoa) Butter, 1Butyrospermum Parkii (Shea) Butter, Tocopherol (Sunflower Vitamin E).

    1
    = Certified Organic
  • Other Information

    Store at temperatures below 90°F.

  • PRINCIPAL DISPLAY PANEL - 18.4 g Tube Box

    Sport

    BADGER®

    Unscented

    Broad Spectrum
    SPF 35

    ZINC OXIDE
    SUNSCREEN

    ALL SEASON
    FACE STICK

    For Surfing & Other
    Permformance Sports

    WATER
    RESISTANT
    80min

    UVA
    UVB

    NON
    NANO

    BIO
    DEGRADABLE

    NATURAL PRODUCTS ASSOCIATION
    CERTIFIED®

    100% CERTIFIED NATURAL
    98% ORGANIC INGREDIENTS

    NSF
    contains organic
    ingredients    CM

    Net Wt 18.4g/.65oz

    Principal Display Panel - 18.4 g Tube Box
  • INGREDIENTS AND APPEARANCE
    BADGER SPF 35 ALL SEASON FACE 
    zinc oxide stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55143-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE22.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55143-101-011 in 1 BOX
    118.4 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35201/01/2014
    Labeler - Norwood Packaging Ltd. (243693926)
    Establishment
    NameAddressID/FEIBusiness Operations
    Norwood Packaging Ltd.243693926MANUFACTURE(55143-101)
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