Label: VANICREAM SUNSCREEN BROAD SPECTRUM SPF 50- zinc oxide cream

  • NDC Code(s): 45334-332-03
  • Packager: Pharmaceutical Specialties, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 23, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient

    Zinc oxide 12%

  • PURPOSE

    Purpose

    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

    • shake well before use
    • 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 allantoin, butyloctyl salicylate, C12-15 alkyl benzoate, caprylyl glycol, dimethiconol/propylsilsesquioxane/silicate crosspolymer, glyceryl behenate, glyceryl dibehenate, glyceryl stearate, isodecyl salicylate, isopropyl isostearate, lecithin, neopentyl glycol diheptanoate, 1,2-hexanediol, polyester-7, polyglyceryl-3 polyricinoleate, propanediol, silica silylate, sodium chloride, squalane, tribehenin, tridecyl salicylate, water

  • QUESTIONS

    Questions or Comments?

    1-800-325-8232

    www.vanicream.com

  • SPL UNCLASSIFIED SECTION

    Vanicream is a trademark, or registered trademark of Pharmaceutical Specialties, Inc. in the U.S. or other countries. ©PSI 2020. All rights reserved.

    Dist. by

    PHARMACEUTICAL SPECIALTIES, INC.

    ROCHESTER, MN 55901 Made in USA

  • PRINCIPAL DISPLAY PANEL

    NDC 45334-332-03

    DERMATOLOGIST TESTED

    New Formula

    VANICREAM™ Sunscreen

    BROAD SPECTRUM SPF 50+

    MINERAL SUNSCREEN

    WATER RESISTANT (80 MINUTES)

    NON-COMEDOGENIC

    Free of dyes, fragrance, masking fragrance, lanolin, parabens, and formaldehyde releasers

    Gluten-Free

    for Sensitive Skin

    Net Wt 3 oz (85 g)

    Vanicream Sunscreen Broad Spectrum SPF50+

  • INGREDIENTS AND APPEARANCE
    VANICREAM SUNSCREEN BROAD SPECTRUM SPF 50 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45334-332
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE12 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ISOPROPYL ISOSTEARATE (UNII: C67IXB9Y7T)  
    ALLANTOIN (UNII: 344S277G0Z)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    DIMETHICONOL/PROPYLSILSESQUIOXANE/SILICATE CROSSPOLYMER (450000000 MW) (UNII: 9KB5R958PB)  
    GLYCERYL MONOBEHENATE (UNII: A626UU0W2A)  
    GLYCERYL 1,3-DIBEHENATE (UNII: 84T2X52XS0)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    ISODECYL SALICYLATE (UNII: S7097PFP4C)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
    WATER (UNII: 059QF0KO0R)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    POLYESTER-7 (UNII: 0841698D2F)  
    SQUALANE (UNII: GW89575KF9)  
    POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)  
    TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    SILICA, TRIMETHYLSILYL CAPPED (UNII: VU10KU4B9S)  
    TRIBEHENIN (UNII: 8OC9U7TQZ0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:45334-332-031 in 1 CARTON04/05/2021
    185 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02004/05/2021
    Labeler - Pharmaceutical Specialties, Inc. (076499557)
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