VANICREAM LIP PROTECTANT/SUNSCREEN (DIMETHICONE, TITANIUM DIOXIDE, ZINC OXIDE) OINTMENT [PHARMACEUTICAL SPECIALTIES, INC.]

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  • VANICREAM LIP PROTECTANT/SUNSCREEN (DIMETHICONE, TITANIUM DIOXIDE, ZINC OXIDE) OINTMENT [PHARMACEUTICAL SPECIALTIES, INC.]

VANICREAM LIP PROTECTANT/SUNSCREEN (DIMETHICONE, TITANIUM DIOXIDE, ZINC OXIDE) OINTMENT [PHARMACEUTICAL SPECIALTIES, INC.]
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NDC 45334-350-35
Set ID 26b7ffcd-d299-628e-e054-00144ff88e88
Category HUMAN OTC DRUG LABEL
Packager Pharmaceutical Specialties, Inc.
Generic Name
Product Class
Product Number
Application Number PART352
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  • Drug Facts

  • Active ingredients

    Dimethicone 1.2%

    Titanium dioxide 1.5%

    Zinc oxide 15%

  • Purpose

    Skin Protectant

    Sunscreen

    Sunscreen

  • 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.
    • helps prevent and temporarily protects chapped or cracked skin and lips
    • helps prevent and protect from the drying effects of wind and cold weather
  • Warnings

    For external use only

  • DO NOT USE

    Do not use on damaged or broken skin

  • WHEN USING

    When using this product keep out of eyes. Rinse with water to remove.

  • STOP USE

    Stop use and ask a doctor if rash occurs

  • KEEP OUT OF REACH OF CHILDREN

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

  • 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
  • Other information

    • protect this product from excessive heat and direct sun
  • Inactive ingredients

    butylene/ethylene/styrene copolymer, C12-15 alkyl benzoate, caprylic/capric triglyceride, ethylene/propylene/styrene copolymer, hydrogenated polyisobutene, isononyl isononanoate, microcrystalline wax, polyhydroxystearic acid, silica dimethyl silylate, stearic acid, triethoxycaprylylsilane

  • Questions?

    1-800-325-8232

    www.vanicream.com

  • SPL UNCLASSIFIED SECTION

    PHARMACEUTICAL SPECIALTIES, INC.

    Rochester, MN 55901

    Made in U.S.A.

    MC15H LIP03

    VANICREAM™ is a trademark, or registered trademark, of Pharmaceutical Specialties, Inc. in the U.S. or other countries.

  • VANICREAM™ Lip Protectant/Sunscreen

    NDC 45334-350-35

    DERMATOLOGIST RECOMMENDED

    • BROAD SPECTRUM SPF 30
    • WATER RESISTANT (80 MINUTES)

    • Helps prevent moisture loss
    • Helps protect from UVA/UVB rays
    • No sensitizing chemical sunscreens
    • Free of dyes, flavoring, fragrance, masking fragrance, lanolin, parabens, formaldehyde & other preservatives
    • Gluten-free

    Net Wt 0.35 oz (10g)

    Vanicream Lip Protectant

  • INGREDIENTS AND APPEARANCE
    VANICREAM LIP PROTECTANT/SUNSCREEN 
    dimethicone, titanium dioxide, zinc oxide ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45334-350
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE15 mg  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION150 mg  in 1 g
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE12 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:45334-350-351 in 1 CARTON09/02/2014
    110 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35209/02/2014
    Labeler - Pharmaceutical Specialties, Inc. (076499557)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharmaceutical Specialties, Inc.076499557manufacture(45334-350) , pack(45334-350) , label(45334-350)
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