Label: VANICREAM SUNSCREEN BROAD SPECTRUM SPF 30- titanium dioxide and zinc oxide cream

  • 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

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 6, 2017

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

    Close
  • ACTIVE INGREDIENT

    Active ingredients

    Titanium dioxide 3.4%

    Zinc oxide 6%

    Close
  • PURPOSE

    Purpose

    Sunscreen

    Sunscreen

    Close
  • 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
    Close
  • 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.

    Close
  • 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
    Close
  • STORAGE AND HANDLING

    Other information protect this product from excessive heat and direct sun

    Close
  • INACTIVE INGREDIENT

    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 Q10)

    Close
  • QUESTIONS

    Questions or Comments? 800-325-8232

    www.vanicream.com Official Vanicream

    Close
  • SPL UNCLASSIFIED SECTION

    PHARMACEUTICAL SPECIALTIES, INC.

    ROCHESTER, MN 55901 Made in USA

    Close
  • SPL UNCLASSIFIED SECTION

    Vanicream™ Sunscreen SPF 30 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)

    Vanicream™ Sunscreen SPF 30 is formulated with zinc oxide and titanium dioxide and does not contain sensitizing chemical sunscreens. It is lightweight, easy-to-spread, and quickly absorbed.

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

    Close
  • SPL UNCLASSIFIED SECTION

    Dermatologist Recommended

    When Vanicream™ Sunscreen SPF 30 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

    Close
  • PRINCIPAL DISPLAY PANEL

    NDC 45334-353-04

    DERMATOLOGIST RECOMMENDED

    VANICREAM™

    Sunscreen

    BROAD SPECTRUM

    SPF 30

    NO SENSITIZING CHEMICAL SUNSCREENS

    WATER RESISTANT (80 MINUTES)

    NON-COMEDOGENIC

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

    Net Wt 4 oz (113 g)

    SPF 30 4 oz Carton

    Close
  • INGREDIENTS AND APPEARANCE
    VANICREAM SUNSCREEN BROAD SPECTRUM SPF 30 
    titanium dioxide and zinc oxide cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:45334-353
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 0.034 g  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 0.06 g  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    C20-40 ALCOHOLS (MP 79C) (UNII: SBX8KS13SG)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)  
    COCO-GLYCERIDES (UNII: ISE9I7DNUG)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    HYDROGENATED POLYBUTENE (370 MW) (UNII: V5H8103878)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    OCTADECENE (UNII: H5ZUQ6V4AK)  
    PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    WATER (UNII: 059QF0KO0R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
    SQUALANE (UNII: GW89575KF9)  
    STEARYL DIMETHICONE (400 MPA.S AT 50C) (UNII: R327X197HY)  
    TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    UBIDECARENONE (UNII: EJ27X76M46)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:45334-353-04 1 in 1 CARTON 04/19/2013
    1 113 g in 1 TUBE; Type 0: Not a Combination Product
    2 NDC:45334-353-07 7 g in 1 TUBE; Type 0: Not a Combination Product 04/19/2013 04/30/2019
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part352 04/19/2013
    Labeler - Pharmaceutical Specialties, Inc. (076499557)
    Establishment
    Name Address ID/FEI Business Operations
    Pharmaceutical Specialties, Inc. 076499557 manufacture(45334-353) , pack(45334-353) , label(45334-353)
    Close