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

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 October 11, 2017

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • ACTIVE INGREDIENT

    Active ingredients

    Octinoxate 2.8%
    Zinc Oxide 11%

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  • PURPOSE

    Purpose

    Sunscreen

    Sunscreen

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  • 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
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  • 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

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

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  • DOSAGE & ADMINISTRATION

    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 of age: 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
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  • STORAGE AND HANDLING

    Other information protect this product from excessive heat and direct sun

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  • INACTIVE INGREDIENT

    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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  • QUESTIONS

    Questions or Comments? 800-325-8232
    www.vanicream.com Official Vanicream

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  • SPL UNCLASSIFIED SECTION

    PHARMACEUTlCAL SPECIALTIES, INC.

    ROCHESTER, MN 55901 Made in USA

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  • SPL UNCLASSIFIED SECTION

    Vanicream™ Sunscreen Sport SPF 35 for sensitive skin is free of dyes, fragrance, masking fragrance, lanolin, parabens, formaldehyde & other preservatives.

    • Oil-free
    • Non-comedogenic (safe for use on face)
    • Odorless
    • Non-greasy
    • No oxybenzone
    • PABA-free
    • Gluten-free
    • Water resistant (80 minutes)

    Formulated with zinc oxide and octinoxate, Vanicream™ Sunscreen Sport SPF 35 is lightweight, easy-to-spread, quickly absorbed, and transparent.

    Recommended for daily use by the entire family. Ideal for even the most delicate, sensitive skin. ( see Directions)

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  • SPL UNCLASSIFIED SECTION

    Dermatologist Recommended

    When Vanicream™ Sunscreen Sport SPF 35 is used as directed with other sun protective measures, it helps provide protection from the sun's harmful rays (UVA and UVB) and decreases the risk of skin cancer and skin aging.

    Coenzyme Q10 is an antioxidant which helps prevent damage to the skin by neutralizing free radicals produced when skin is exposed to the sun.

    For information on our other products for sensitive skin, visit our website at www.vanicream.com or call 1-800-325-8232.

    Official Vanicream

    for Sensitive Skin

    Kid Friendly

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  • PRINCIPAL DISPLAY PANEL

    NDC 45334-355-04

    DERMATOLOGIST RECOMMENDED

    VANICREAM™

    Sunscreen Sport

    BROAD SPECTRUM

    SPF 35

    FOR SENSITIVE SKIN

    WATER RESISTANT (80 MINUTES)

    NON-COMEDOGENIC

    Free of dyes, fragrance, masking fragrance, lanolin, parabens, formaldehyde, & other preservatives

    Net Wt. 4 oz (113 g)

    SPF 35 4 oz carton MC15O

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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
    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)  
    SILICA, TRIMETHYLSILYL CAPPED (UNII: VU10KU4B9S)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:45334-355-04 1 in 1 CARTON 04/18/2013
    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 04/18/2013
    3 NDC:45334-355-07 7 g in 1 TUBE; Type 0: Not a Combination Product 04/18/2013
    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)
    Establishment
    Name Address ID/FEI Business Operations
    Pharmaceutical Specialties, Inc. 076499557 manufacture(45334-355) , pack(45334-355)
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