Label: BADGER LAVENDER SPF 30 SUNSCREEN- zinc oxide cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 January 2, 2014

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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/cm2 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

    1Helianthus Annuus (Sunflower) Oil, 1Cera Alba (Beeswax), 1Lavandula Angustifolia (Lavender) Essential Oil, Tocopherol (Sunflower Vitamin E), 1Hippophae Rhamnoides (Seabuckthorn) CO2 Extract.

    1
    = Certified Organic
  • Other Information

    Store at temperatures below 90°F.

  • PRINCIPAL DISPLAY PANEL - 87 mL Tube Label

    Active

    BADGER®

    Lavender

    Broad Spectrum
    SPF 30

    ZINC OXIDE
    SUNSCREEN CREAM

    Safe • Effective • Family Friendly

    WATER
    RESISTANT
    40 min

    UVA
    UVB

    NON
    NANO

    BIO
    DEGRADABLE

    NATURAL PRODUCTS ASSOCIATION
    • CERTIFIED •

    100% CERTIFIED NATURAL
    98% ORGANIC INGREDIENTS

    NSF
    contains organic
    ingredients

    87ml/2.9 fl.oz

    Principal Display Panel - 87 mL Tube Label
  • INGREDIENTS AND APPEARANCE
    BADGER LAVENDER SPF 30 SUNSCREEN 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55143-100
    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)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    HIPPOPHAE RHAMNOIDES FRUIT (UNII: AVL0R9111T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55143-100-0187 mL 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(55143-100)
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