Label: COVERGIRL VITALIST HEALTHY FOUNDATION WITH VITAMINS PLUS ENSULIZOLE SUNSCREEN BROAD SPECTRUM SPF 20 (ALL SHADES) - ensulizole liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 February 20, 2019

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredient

    Ensulizole 3%.

    Purpose

    Sunscreen

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  • 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

    • 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 product is swallowed, get medical help or contact a Poison Control Center right away

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  • Directions

    • apply liberally 15 minutes before sun exposure
    • reapply at least every 2 hours
    • use water resistant sunscreen if swimming or sweating
    • 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 sun, especially from 10 a.m. – 2 p.m.
    • wear long-sleeved shirts, pants, hats, and sunglasses
    • children under 6 months: ask a doctor
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  • Other information

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

    Water, cyclopentasiloxane, propylene glycol, glycerin, titanium dioxide, dimethicone, talc, aluminum starch octenylsuccinate, peg/ppg-18/18 dimethicone, pvp, sodium chloride, phenoxyethanol, sodium hydroxide, trihydroxystearin, arachidyl behenate, caprylyl glycol, 1,2-hexanediol, methicone, fragrance, sodium benzoate, silica, acrylonitrile/methyl methacrylate/vinylidene chloride copolymer, synthetic wax, polyglyceryl-4 isostearate, hexyl laurate, cetyl peg/ppg-10/1 dimethicone, tocopheryl acetate, panthenol, niacinamide, ethylene brassylate, behenic acid, polyethylene, isopropyl titanium triisostearate, iron oxides

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  • Questions?

    Call 1-800-426-8374

    MADE IN USAOF US & IMPORTED PARTS

    COTYUS LLC, NEW YORK, NY 10118

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  • Principal Display Panel - Covergirl Vitalist Healthy Elixir Label

    COVERGIRL

    vitalist

    HEALTHY

    ELIXIR

    FOUNDATION WITH VITAMINS +
    ENSULIZOLE SUNSCREEN
    BROAD SPECTRUM SPF 20

    705

    30 mL (1 FL OZ)

    Principal Display Panel - Covergirl Vitalist Healthy Elixir Label
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  • INGREDIENTS AND APPEARANCE
    COVERGIRL VITALIST HEALTHY FOUNDATION WITH VITAMINS PLUS ENSULIZOLE SUNSCREEN BROAD SPECTRUM SPF 20 (ALL SHADES)  
    ensulizole liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:22700-200
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE 3 g  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    TALC (UNII: 7SEV7J4R1U)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    TRIHYDROXYSTEARIN (UNII: 06YD7896S3)  
    ARACHIDYL BEHENATE (UNII: 9G00Q0O2NS)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    METHICONE (20 CST) (UNII: 6777U11MKT)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    ETHYLENE BRASSYLATE (UNII: 9A87HC7ROD)  
    BEHENIC ACID (UNII: H390488X0A)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:22700-200-30 30 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 06/01/2017
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 06/01/2017
    Labeler - Noxell Corporation (003082997)
    Registrant - COTY US LLC (039056361)
    Establishment
    Name Address ID/FEI Business Operations
    Noxell Corporation 003082997 manufacture(22700-200)
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