Label: MATCHMASTER FOUNDATION SPF 15- octinoxate, titanium dioxide lotion

  • 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 12, 2011

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS: OCTINOXATE 3.40% [] TITANIUM DIOXIDE 1.00%

  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS: WATER [] CYCLOPENTASILOXANE [] POLYMETHYL METHACRYLATE [] BUTYLENE GLYCOL [] PEG-10 DIMETHICONE [] TRIMETHYLSILOXYSILICATE [] DIMETHICONE [] MAGNESIUM SULFATE [] TOCOPHEROL [] TOCOPHERYL ACETATE [] SODIUM HYALURONATE [] LECITHIN [] HYDROGENATED LECITHIN [] ALGAE EXTRACT [] LAMINARIA SACCHARINA EXTRACT [] DIPROPYLENE GLYCOL [] XANTHAN GUM [] LAURETH-7 [] SORBITAN SESQUIOLEATE [] DIMETHICONE/PEG-10/15 CROSSPOLYMER [] DIMETHICONE/PEG-10 CROSSPOLYMER [] PEG/PPG-18/18 DIMETHICONE [] TRIETHOXYCAPRYLYLSILANE [] DIMETHICONE SILYLATE [] DIMETHICONE CROSSPOLYMER [] SILICA [] PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE [] CHLOROXYLENOL [] PHENOXYETHANOL [] SORBIC ACID []  [+/- IRON OXIDES (CI 77491, CI 77492, CI 77499) [] TITANIUM DIOXIDE (CI 77891) [] CHROMIUM OXIDE GREENS (CI 77288)]

  • WARNINGS

    WARNING: KEEP OUT OF EYES.  IF IRRITATION PERSISTS STOP USE AN CONTACT A HEALTH CARE PRACTITIONER. KEEP OUT OF REACH OF CHILDREN. APPLY BEFORE SUN EXPOSURE

  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL:



    MAC

    MATCHMASTER FOUNDATION

    SPF 15



    1.2 FL. OZ. LIQ/35 ML



    MAKEUP ART COSMETICS, DIST

    TORONTO, ONTARIO, CANADA,  M5V 1R7

    FOLDING CARTON

  • INGREDIENTS AND APPEARANCE
    MATCHMASTER FOUNDATION  SPF 15
    octinoxate, titanium dioxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:40046-0045
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3.4 mL  in 100 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.0 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    TRIMETHYLSILANE (UNII: 9L70DJH2K0)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)  
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    SEAWEED (UNII: 477TV3P5UX)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    LAURETH-7 (UNII: Z95S6G8201)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
    CHLOROXYLENOL (UNII: 0F32U78V2Q)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SORBIC ACID (UNII: X045WJ989B)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    CHROMIC OXIDE (UNII: X5Z09SU859)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:40046-0045-11 in 1 CARTON
    1NDC:40046-0045-235 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35206/01/2011
    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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