BAMBO NATURE SUNNY DAY (TITANIUM DIOXIDE) CREAM [DERMAPHARM A/S]

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BAMBO NATURE SUNNY DAY (TITANIUM DIOXIDE) CREAM [DERMAPHARM A/S]
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NDC 24959-001-01, 24959-001-02
Set ID 5160be3d-d431-6577-e054-00144ff8d46c
Category HUMAN OTC DRUG LABEL
Packager DermaPharm A/S
Generic Name
Product Class
Product Number
Application Number PART352
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  • ACTIVE INGREDIENT

    Active Ingredient

    Titanium Dioxide 8.46%

  • PURPOSE

    Purpose

    Sunscreen

  • KEEP OUT OF REACH OF CHILDREN

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

  • INDICATIONS & USAGE

    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

  • DOSAGE & ADMINISTRATION

    Directions

    • Apply liberally and evenly 15 minutes before sun exposure
    • Reapply: • after 80 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours
    • Children under 6 months: ask a doctor

    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 10 a.m. - 2 p.m.
    • wear long-sleeved shirts, pants, hats, and sunglasses
  • WARNINGS

    Warnings

    For external use only

    Do not use on damaged or broken skin.

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

    Stop use and ask a doctor if rash occurs.

  • INACTIVE INGREDIENT

    Inactive ingredients

    Aloe Barbadensis Leaf Extract*, Alumina, Caprylic/Capric Triglyceride, Glycerin**, Magnesium Sulfate, Polyglyeryl-2 Dipolyhydroxystearate, Polyglyeryl-3 Diisostearate, Polyhydroxystearic Acid, Stearic Acid, Tocopherol, Water.

    *Ingredients from organic farming

    **Made using organic ingredients

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    BAMBO NATURE SUNNY DAY 
    titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24959-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE8.46 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    WATER (UNII: 059QF0KO0R)  
    CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24959-001-01150 g in 1 BOTTLE; Type 0: Not a Combination Product06/01/2017
    2NDC:24959-001-0230 g in 1 BOTTLE; Type 0: Not a Combination Product06/01/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35206/01/2017
    Labeler - DermaPharm A/S (306036476)
    Establishment
    NameAddressID/FEIBusiness Operations
    DermaPharm A/S306036476manufacture(24959-001)
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