Label: VANICREAM- titanium dioxide and zinc oxide cream 

  • Label RSS
  • NDC Code(s): 45334-353-04, 45334-353-07
  • Packager: Pharmaceutical Specialties, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 03/14

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • ACTIVE INGREDIENT

    Active Ingredients: Purpose
    Titanium Dioxide 3.4% Sunscreen
    Zinc Oxide 6% Sunscreen
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  • 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
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  • Warnings

    For external use only

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

    Stop use and ask a doctor if rash occurs

    Do not use on damaged or broken skin

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

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  • Directions

    • apply liberally 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 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
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  • Inactive Ingredients

    C20-40 alcohols, caprylyl glycol, cetyl PEG/PPG-10/1 dimethicone, cocoglycerides, dicaprylyl carbonate, dimethicone, 1 ,2 hexanediol, hydrogenated castor oil, hydrogenated polyisobutene, magnesium chloride, octadecene, PEG-30 dipolyhydroxystearate, pentylene glycol, phenyl trimethicone, purified water, silica, silica dimethyl silylate, squalane, stearyl dimethicone, tridecyl salicylate, triethoxycaprylylsilane, ubiquinone (coenzyme 010)

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  • STORAGE AND HANDLING

    Other information protect this product from excessive heat and direct sun

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  • QUESTIONS

    Questions or Comments 800-325-8232

    www.vanicream.com official Vanicream

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  • PRINCIPAL DISPLAY PANEL - 113 g Tube Carton

    PRINCIPAL DISPLAY PANEL - 113g Tube Carton

    VANICREAM™

    Sunscreen

    BROAD SPECTRUM

    SPF 30

    NO SENSITIZING CHEMICAL SUNSCREENS

    WATER RESISTANT (80 MINUTES)

    NON-COMEDOGENIC

    Free of dyes, lanolin, fragrance, masking fragrance,

    parabens, formaldehyde,

    &

    other preservatives

    Net Wt 4 oz ( 113 g)

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  • PRINCIPAL DISPLAY PANEL - 7 g Tube Label

    PRINCIPAL DISPLAY PANEL - 7 g Tube Label

    VANICREAM™

    BROAD SPECTRUM

    SPF 30

    WATER RESISTANT (80 MINUTES)

    NON-COMEDOGENIC

    NO SENSITIZING CHEMICAL SUNSCREENS

    For Sensitive Skin

    Free of dyes, lanolin, fragrance, masking fragrance,

    parabens, formaldehyde,

    &

    other preservatives

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  • INGREDIENTS AND APPEARANCE
    VANICREAM 
    titanium dioxide and zinc oxide cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:45334-353
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Titanium Dioxide (Titanium Dioxide) Titanium Dioxide 0.034 g  in 1 g
    Zinc Oxide (Zinc Oxide) Zinc Oxide 0.06 g  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    CAPRYLYL GLYCOL  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5)  
    COCO-GLYCERIDES  
    DICAPRYLYL CARBONATE  
    DIMETHICONE  
    HEXANEDIOL  
    HYDROGENATED CASTOR OIL  
    HYDROGENATED POLYBUTENE (1300 MW)  
    MAGNESIUM CHLORIDE  
    OCTADECENE  
    PEG-30 DIPOLYHYDROXYSTEARATE  
    PENTYLENE GLYCOL  
    PHENYL TRIMETHICONE  
    WATER  
    SILICON DIOXIDE  
    SILICA DIMETHYL SILYLATE  
    SQUALANE  
    STEARYL DIMETHICONE (400 MPA.S AT 50C)  
    TRIDECYL SALICYLATE  
    TRIETHOXYCAPRYLYLSILANE  
    UBIDECARENONE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:45334-353-04 1 in 1 CARTON
    1 113 g in 1 TUBE
    2 NDC:45334-353-07 7 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part352 02/01/2012
    Labeler - Pharmaceutical Specialties, Inc. (076499557)
    Registrant - Pharmaceutical Specialties, Inc. (076499557)
    Establishment
    Name Address ID/FEI Business Operations
    Pharmaceutical Specialties, Inc. 076499557 manufacture(45334-353), pack(45334-353)
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