BADGER UNSCENTED SPF 30 SUNSCREEN (ZINC OXIDE) CREAM [W.S. BADGER COMPANY, INC.]

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BADGER UNSCENTED SPF 30 SUNSCREEN (ZINC OXIDE) CREAM [W.S. BADGER COMPANY, INC.]
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NDC 62206-4740-0
Set ID 2779d30f-a003-4bb1-9747-9686d438c91c
Category HUMAN OTC DRUG LABEL
Packager W.S. Badger Company, Inc.
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 18.75%

  • 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/cm 2 of skin) to all exposed skin 15 minutes before sun exposure, then rub in to reduce whitening effect.

    Reapply:

    • After 40 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 a 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


    *Helianthus Annuus ( Sunflower) Oil, *Cera Alba (Beeswax), Tocopherol (Sunflower Vitamin E), *Hippophae Rhamnoides (Seabuckthorn) Fruit Extract.


    * = Certified Organic

  • Other Information

    Protect the product in this container from excessive heat and direct sunlight.

  • PRINCIPAL DISPLAY PANEL - 87 ml Tube Label

    Label

    Active

    BADGER     ®

    Unscented

    Broad Spectrum

    SPF 30

    NATURAL MINERAL
    SUNSCREEN CREAM

    Safe • Effective • Family Friendly

    WATER RESISTANT 40min

    NON GMO

    NON NANO

    BIO DEGRADABLE


    98% ORGANIC INGREDIENTS

    NSF

    87ml/2.9 fl.oz

  • INGREDIENTS AND APPEARANCE
    BADGER UNSCENTED SPF 30 SUNSCREEN 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62206-4740
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE18.75 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    HIPPOPHAE RHAMNOIDES FRUIT (UNII: AVL0R9111T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62206-4740-087 mL in 1 TUBE; Type 0: Not a Combination Product11/02/201509/24/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/02/201509/30/2022
    Labeler - W.S. Badger Company, Inc. (963242326)
    Establishment
    NameAddressID/FEIBusiness Operations
    W.S. BADGER COMPANY, INC.963242326manufacture(62206-4740)
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