BADGER SPF 15 SUNSCREEN LIP BALM (ZINC OXIDE) STICK [NORWOOD PACKAGING LTD.]

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  • BADGER SPF 15 SUNSCREEN LIP BALM (ZINC OXIDE) STICK [NORWOOD PACKAGING LTD.]

BADGER SPF 15 SUNSCREEN LIP BALM (ZINC OXIDE) STICK [NORWOOD PACKAGING LTD.]
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NDC 55143-108-01
Set ID 283e55c9-3e87-4303-9f8f-60b05922aaa8
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 8%

  • 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 swallowed, get medical help or contact a poison control center right away.

  • Directions

    • For full protection, apply liberally (2mg/cm2 of skin) to lips, then rub in to reduce whitening effect
    • Use a water resistant sunscreen if swimming or sweating

    Reapply:

    • 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
  • PRINCIPAL DISPLAY PANEL - 4.2 g Tube Box

    FAMILY FRIENDLY • CERTIFIED NATURAL

    BADGER®

    Unscented

    Broad Spectrum SPF 15

    SUNSCREEN LIP BALM

    Net Wt 4.2g/.15 oz

    UVA
    UVB

    NON
    NANO

    BIO
    DEGRADABLE

    Principal Display Panel - 4.2 g Tube Box
  • INGREDIENTS AND APPEARANCE
    BADGER SPF 15 SUNSCREEN LIP BALM 
    zinc oxide stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55143-108
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE8 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:55143-108-011 in 1 BOX
    14.2 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(55143-108)
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