Label: PREP AND PRIME FORTIFIED SKIN ENHANCER SPF 35- octinoxate, octisalate, zinc oxide, oxybenzone cream

  • 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 July 14, 2011

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS: OCTINOXATE 7.40% [] OCTISALATE 4.00% [] ZINC OXIDE 3.50% [] OXYBENZONE 2.50% [] TITANIUM DIOXIDE 1.10%

  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS: WATER\AQUA\EAU [] DIMETHICONE [] BUTYLENE GLYCOL [] PHENYL TRIMETHICONE [] PENTYLENE GLYCOL [] GLYCERYL STEARATE [] BEHENYL ALCOHOL [] TRIOCTYLDODECYL CITRATE [] POLYMETHYLSILSESQUIOXANE [] OCTYLDODECYL STEAROYL STEARATE [] PEG-40 STEARATE [] POLYGLYCERYL-10 PENTASTEARATE [] OCTYLDODECYL NEOPENTANOATE [] TOCOPHERYL ACETATE [] CAFFEINE [] GLYCYRRHETINIC ACID [] UREA [] SODIUM HYALURONATE [] SQUALANE [] HORDEUM VULGARE (BARLEY) EXTRACT\EXTRAIT D'ORGE [] TRITICUM VULGARE (WHEAT) GERM EXTRACT [] LAMINARIA SACCHARINA EXTRACT [] GLYCERIN [] LECITHIN [] POLYGLYCERYL-6 POLYRICINOLEATE [] CHOLESTEROL [] TREHALOSE [] SODIUM PCA [] ORYZANOL [] AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER [] SUCROSE [] SODIUM STEAROYL LACTYLATE [] XANTHAN GUM [] POLYQUATERNIUM-51 [] ISOPROPYL TITANIUM TRIISOSTEARATE [] TRIETHOXYCAPRYLYLSILANE [] SILICA [] ALUMINA [] LINOLEIC ACID [] STEARIC ACID [] PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE [] DISODIUM EDTA [] PHENOXYETHANOL [] CHLORPHENESIN [] SODIUM DEHYDROACETATE []  [+/- MICA [] TITANIUM DIOXIDE (CI 77891) [] IRON OXIDES (CI 77491, CI 77492, CI 77499) [] BISMUTH OXYCHLORIDE (CI 77163) [] BLUE 1 LAKE (CI 42090) [] CARMINE (CI 75470) [] CHROMIUM HYDROXIDE GREEN (CI 77289) [] FERRIC FERROCYANIDE (CI 77510) [] YELLOW 5 LAKE (CI 19140)]

  • WHEN USING

    DIRECTIONS: SMOOTH EVENLY ALL OVER THE FACE OR TO THE DESIRED AREAS AFTER MOISTURIZER WITH FINGERTIPS, SPONGE OR BRUSH.

  • WARNINGS

    WARNING: KEEP OUT OF EYES. STOP USE IF IRRITATION OCCURS. IF IRRITATION PERSISTS, DISCONTINUE USE AND CONTACT A HEALTH CARE PRACTITIONER.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.

  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL:

    MAC

    PREP + PRIME

    FORTIFIED SKIN ENHANCER

    SPF 35


    NT WT 1.0 FL OZ/ 30 ML



    DISTR BY MAKE UP ART COSMETICS

    TORONTO, ONTARIO, CANADA M5V 1R7

    FOLDING CARTON




  • INGREDIENTS AND APPEARANCE
    PREP AND PRIME  FORTIFIED SKIN ENHANCER SPF 35
    octinoxate, octisalate, zinc oxide, oxybenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:40046-0039
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.4 mL  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4.0 mL  in 100 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE3.5 mL  in 100 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE2.5 mL  in 100 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.1 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)  
    OCTYLDODECYL STEAROYL STEARATE (UNII: 3D47Q6D93C)  
    PEG-40 STEARATE (UNII: ECU18C66Q7)  
    OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CAFFEINE (UNII: 3G6A5W338E)  
    ENOXOLONE (UNII: P540XA09DR)  
    UREA (UNII: 8W8T17847W)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    SQUALANE (UNII: GW89575KF9)  
    BARLEY (UNII: 5PWM7YLI7R)  
    WHEAT GERM (UNII: YR3G369F5A)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    TREHALOSE (UNII: B8WCK70T7I)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    GAMMA ORYZANOL (UNII: SST9XCL51M)  
    SUCROSE (UNII: C151H8M554)  
    SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    LINOLEIC ACID (UNII: 9KJL21T0QJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    MICA (UNII: V8A1AW0880)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:40046-0039-11 in 1 CARTON
    1NDC:40046-0039-230 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35204/01/2011
    Labeler - MAKEUP ART COSMETICS (010597206)
    Establishment
    NameAddressID/FEIBusiness Operations
    ESTEE LAUDER COSMETICS, LTD205952385manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    ESTEE LAUDER N.V.370151326manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Len-Ron Manufacturing Division of Aramis Inc.809771152manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Aramis Inc.042918826manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Northtec Bristol949264774manufacture, relabel, repack
    Establishment
    NameAddressID/FEIBusiness Operations
    Northtec Keystone618107429manufacture, relabel, repack
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder Pennsylvania Distribution Center 2828534516manufacture, relabel, repack
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder Cosmetics, Ltd.255175580manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder Cosmetics, Ltd253616536manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder Cosmetics Distribution Center208579636repack, relabel
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder Kabushiki Kaisha712808195relabel, repack
    Establishment
    NameAddressID/FEIBusiness Operations
    Whitman Laboratories Ltd.216866277manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Aveda Corporation071352058manufacture
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