VANICREAM SUNSCREEN BROAD SPECTRUM SPF 35 (OCTINOXATE AND ZINC OXIDE) CREAM [PHARMACEUTICAL SPECIALTIES, INC.]

VANICREAM SUNSCREEN BROAD SPECTRUM SPF 35 (OCTINOXATE AND ZINC OXIDE) CREAM [PHARMACEUTICAL SPECIALTIES, INC.]
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NDC 45334-355-02, 45334-355-04, 45334-355-07
Set ID 8a4db0fc-d5b4-4eb0-8fa5-bb8cdacdb232
Category HUMAN OTC DRUG LABEL
Packager Pharmaceutical Specialties, Inc.
Generic Name
Product Class
Product Number
Application Number PART352
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients

    Octinoxate 2.8%
    Zinc Oxide 11%

  • PURPOSE

    Purpose

    Sunscreen

    Sunscreen

  • 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
  • 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.

  • 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
  • STORAGE AND HANDLING

    Other information protect this product from excessive heat and direct sun

  • 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)

  • QUESTIONS

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

  • SPL UNCLASSIFIED SECTION

    PHARMACEUTlCAL SPECIALTIES, INC.

    ROCHESTER, MN 55901 Made in USA

  • 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)

  • SPL UNCLASSIFIED SECTION

    Dermatologist Tested

    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.

    Contains Coenzyme Q10.

    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

  • PRINCIPAL DISPLAY PANEL

    NDC 45334-355-04

    DERMATOLOGIST TESTED

    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 4oz MC18B

  • INGREDIENTS AND APPEARANCE
    VANICREAM SUNSCREEN BROAD SPECTRUM SPF 35 
    octinoxate and zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45334-355
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.028 g  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.11 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:45334-355-041 in 1 CARTON04/18/201309/30/2022
    1113 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:45334-355-0257 g in 1 TUBE; Type 0: Not a Combination Product04/18/201303/31/2019
    3NDC:45334-355-077 g in 1 TUBE; Type 0: Not a Combination Product04/18/201309/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35204/18/201309/30/2022
    Labeler - Pharmaceutical Specialties, Inc. (076499557)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharmaceutical Specialties, Inc.076499557manufacture(45334-355) , pack(45334-355)

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