Label: VIRTUAL SKIN SUPER NATURAL FINISH SPF 10- octinoxate liquid

  • Category: HUMAN OTC DRUG LABEL

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 April 24, 2012

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENT: OCTINOXATE 5.40%

  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS: WATER\AQUA\EAU [] DIMETHICONE [] CYCLOPENTASILOXANE [] GLYCERYL STEARATE SE [] HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER [] BUTYLENE GLYCOL [] TALC [] CHOLESTEROL [] TRITICUM VULGARE (WHEAT BRAN) EXTRACT [] MELANIN [] SODIUM HYALURONATE [] TOCOPHERYL ACETATE [] OLEA EUROPAEA (OLIVE) FRUIT EXTRACT [] POLYACRYLAMIDE [] ETHYLHEXYLGLYCERIN [] PALMITIC ACID [] C13-14 ISOPARAFFIN [] CAPRYLYL GLYCOL [] LAURETH-7 [] HEXYLENE GLYCOL [] LINOLEIC ACID [] PEG-9 DIMETHICONE [] SILICA [] CITRIC ACID [] SODIUM CITRATE [] DISODIUM EDTA [] SORBIC ACID [] BENZOIC ACID [] POTASSIUM SORBATE [] PHENOXYETHANOL []  [+/- TITANIUM DIOXIDE (CI 77891) [] IRON OXIDES (CI 77491, CI 77492, CI 77499) [] MICA

  • WARNINGS

    WARNINGS: FOR EXTERNAL USE ONLY. KEEP OUT OF EYES. RINSE WITH WATER TO REMOVE. STOP USE AND ASK A DOCTOR IF SKIN RASH OR IRRITATION OCCURS. KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

  • PRINCIPAL DISPLAY PANEL

    PRESCRIPTIVES
    VIRTUAL SKIN
    SUPER NATURAL FINISH
    SPF 10

    1.0 FL OZ LIQ/ 30 ML


    PRESCRIPTIVES CO. DIST
    NY NY 10022

    FOLDING CARTON

  • INGREDIENTS AND APPEARANCE
    VIRTUAL SKIN   SUPER NATURAL FINISH SPF 10
    octinoxate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59158-759
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE5.4 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    TALC (UNII: 7SEV7J4R1U)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    WHEAT BRAN (UNII: 6L966A1IMR)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    BLACK OLIVE (UNII: 2M6QWV94OC)  
    POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    LAURETH-7 (UNII: Z95S6G8201)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    LINOLEIC ACID (UNII: 9KJL21T0QJ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SORBIC ACID (UNII: X045WJ989B)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    MICA (UNII: V8A1AW0880)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59158-759-011 in 1 CARTON
    1NDC:59158-759-0230 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35201/01/1999
    Labeler - PRESCRIPTIVES INC. (151701588)
    Establishment
    NameAddressID/FEIBusiness Operations
    Len-Ron Manufacturing Division of Aramis Inc.809771152manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder Inc042918826manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Northtec Keystone949264774manufacture, relabel, repack
    Establishment
    NameAddressID/FEIBusiness Operations
    Northtec Bristol959338336manufacture, relabel, repack
    Establishment
    NameAddressID/FEIBusiness Operations
    Northtec Keystone943871157manufacture, relabel, repack
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder Pennsylvania Distribution Center 2828534516manufacture, relabel, repack
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder Cosmetics Ltd.205952385manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder Cosmetics, Ltd.244669714manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder Cosmetics, Ltd.253616536manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder Cosmetics Distribution Centre208579636repack, relabel
    Establishment
    NameAddressID/FEIBusiness Operations
    ELGC K.K.712808195relabel, repack
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder N.V.370151326manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Whitman Laboratories Ltd.216866277manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Aveda Corporation071352058manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Pennsylvania Logistics Center (PALC)078364654repack, relabel
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