Label: VANICREAM SUNSCREEN BROAD SPECTRUM SPF 35- octinoxate and zinc oxide cream

  • NDC Code(s): 45334-355-02, 45334-355-04, 45334-355-07
  • 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 03/15

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

  • Drug Facts
  • Active Ingredients

    Octinoxate 2.8%
    Zinc Oxide 11%

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  • Purpose

    Sunscreen

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  • Uses

    • helps prevent sunburn
    • if used as directed with other sun protective 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, cetyl PEG/PPG-10/1 dimethicone, cyclohexasiloxane, cyclopentasiloxane, cyclotetrasiloxane, dimethiconol, glycerin, hydrogenated castor oil, magnesium chloride, PEG-30 dipolyhydroxystearate, polypropyl silsesquioxane, purified water, tridecyl neopentanoate, triethoxycaprylylsilane, trimethylsiloxy silicate, ubiquinone (coenzyme Q10)

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  • Other Information

    protect this product from excessive heat and direct sun

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  • Questions or Comments

    800-325-8232
    www.vanicream.com

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  • DESCRIPTION

    PHARMACEUTlCAL SPECIALTIES, INC.

    ROCHESTER, MN 55903-6298 Made in USA

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  • INGREDIENTS AND APPEARANCE
    VANICREAM SUNSCREEN BROAD SPECTRUM SPF 35 
    octinoxate and zinc oxide cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:45334-355
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.028 g  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 0.11 g  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    C20-40 ALCOHOLS (MP 79C) (UNII: SBX8KS13SG)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    CYCLOMETHICONE 4 (UNII: CZ227117JE)  
    DIMETHICONOL GUM (UNII: 4MJ9GU3T1P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)  
    PROPYLSILSESQUIOXANE, HYDROGEN TERMINATED (UNII: 2PDG9JR76G)  
    WATER (UNII: 059QF0KO0R)  
    TRIDECYL NEOPENTANOATE (UNII: 3Z8H1DA7J5)  
    UBIDECARENONE (UNII: EJ27X76M46)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:45334-355-04 1 in 1 CARTON
    1 113 g in 1 TUBE; Type 0: Not a Combination Product
    2 NDC:45334-355-02 57 g in 1 TUBE; Type 0: Not a Combination Product
    3 NDC:45334-355-07 7 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part352 04/18/2013
    Labeler - Pharmaceutical Specialties, Inc. (076499557)
    Registrant - Pharmaceutical Specialties, Inc. (076499557)
    Establishment
    Name Address ID/FEI Business Operations
    Pharmaceutical Specialties, Inc. 076499557 manufacture(45334-355) , pack(45334-355)
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