MAC HYPER REAL SPF 15 FOUNDATION (OCTINOXATE) LIQUID [MAKEUP ART COSMETICS]

MAC HYPER REAL SPF 15 FOUNDATION (OCTINOXATE) LIQUID [MAKEUP ART COSMETICS]
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NDC 40046-0056-1
Set ID 36e3b619-a9a3-4baf-8b01-248b357ed3eb
Category HUMAN OTC DRUG LABEL
Packager MAKEUP ART COSMETICS
Generic Name
Product Class
Product Number
Application Number PART352
  • WARNING

    KEEP OUT OF EYES.

    STOP USE IF IRRITATION OCCURS.

    KEEP OUT OF REACH OF CHILDREN.

  • ACTIVE INGREDIENT

    OCTINOXATE 7.00%

  • INGREDIENTS

    WATER (AQUA PURIFICATA) PURIFIED, CYCLOPENTASILOXANE, BUTYLENE GLYCOL, SILICA, DIMETHICONE, PHENYL TRIMETHICONE, BIS-PEG/PPG-14/14 DIMETHICONE, MAGNESIUM SULFATE, TRIMETHYLSILOXYSILICATE, TITANIUM DIOXIDE, TOCOPHERYL ACETATE, RETINYL PALMITATE, ASCORBYL PALMITATE, DISTEARDIMONIUM HECTORITE, TRIETHOXYCAPRYLYLSILANE, POLYGLYCERYL-4 ISOSTEARATE, HEXYL LAURATE, CETYL PEG/PPG-10/1 DIMETHICONE, LAURETH-7, TRIETHYL CITRATE, PHENOXYETHANOL, METHYLPARABEN [+/-(MAY CONTAIN): MICA, TITANIUM DIOXIDE (CI 77891), IRON OXIDES (CI 77491, CI 77492, CI 77499), BISMUTH OXYCHLORIDE (CI 77163), CHROMIUM OXIDE GREENS (CI 77288)] <ILN28730>

  • SPL UNCLASSIFIED SECTION

    DIST. BY/PAR: MAKE-UP ART COSMETICS
    TORONTO, ONTARIO, CANADA M5V 1R7,
    LONDON W1K 3BQ. / M49W

  • PRINCIPAL DISPLAY PANEL - 30 ML Bottle Carton

    M•A•C

    HYPER REAL SPF 15
    FOUNDATION

    30 ML/1.0 US FL OZ e

    PRINCIPAL DISPLAY PANEL - 30 ML Bottle Carton
  • INGREDIENTS AND APPEARANCE
    MAC   HYPER REAL SPF 15 FOUNDATION
    octinoxate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:40046-0056
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    MAGNESIUM SULFATE (UNII: DE08037SAB)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    LAURETH-7 (UNII: Z95S6G8201)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    MICA (UNII: V8A1AW0880)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
    CHROMIC OXIDE (UNII: X5Z09SU859)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:40046-0056-11 in 1 CARTON
    130 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35206/01/2003
    Labeler - MAKEUP ART COSMETICS (010597206)
    Establishment
    NameAddressID/FEIBusiness Operations
    ELGC K.K.712808195RELABEL(40046-0056) , REPACK(40046-0056)
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder Pennsylvania Distribution Center 2 (PADC 2)828534516MANUFACTURE(40046-0056) , RELABEL(40046-0056) , REPACK(40046-0056)
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder Inc.042918826MANUFACTURE(40046-0056)
    Establishment
    NameAddressID/FEIBusiness Operations
    ESTEE LAUDER COSMETICS DISTRIBUTION CENTER208579636REPACK(40046-0056) , RELABEL(40046-0056)
    Establishment
    NameAddressID/FEIBusiness Operations
    ESTEE LAUDER COSMETICS, LTD253616536MANUFACTURE(40046-0056)
    Establishment
    NameAddressID/FEIBusiness Operations
    ESTEE LAUDER COSMETICS, LTD244669714MANUFACTURE(40046-0056)
    Establishment
    NameAddressID/FEIBusiness Operations
    ESTEE LAUDER COSMETICS, LTD.205952385MANUFACTURE(40046-0056)
    Establishment
    NameAddressID/FEIBusiness Operations
    ESTEE LAUDER N.V.370151326MANUFACTURE(40046-0056)
    Establishment
    NameAddressID/FEIBusiness Operations
    LEN-RON MANUFACTURING DIVISION OF ARAMIS INC809771152MANUFACTURE(40046-0056)
    Establishment
    NameAddressID/FEIBusiness Operations
    NORTEC KEYSTONE943871157MANUFACTURE(40046-0056) , RELABEL(40046-0056) , REPACK(40046-0056)
    Establishment
    NameAddressID/FEIBusiness Operations
    NORTHTEC BRISTOL959338336MANUFACTURE(40046-0056) , RELABEL(40046-0056) , REPACK(40046-0056)
    Establishment
    NameAddressID/FEIBusiness Operations
    NORTHTEC KEYSTONE949264774MANUFACTURE(40046-0056) , RELABEL(40046-0056) , REPACK(40046-0056)
    Establishment
    NameAddressID/FEIBusiness Operations
    WHITMAN LABORATORIES, LTD.216866277MANUFACTURE(40046-0056)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aveda Corporation071352058MANUFACTURE(40046-0056)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pennsylvania Logistics Center078364654REPACK(40046-0056) , RELABEL(40046-0056)

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