Label: MINERALIZE SATIN FOUNDATION SPF 15 FOUNDATION- octinoxate 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 May 18, 2011

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

  • ACTIVE INGREDIENT

    ACTIVE INGREDIENT: OCTINOXATE 7.5%

  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS: WATER [] BUTYLENE GLYCOL [] TRIETHYLHEXANOIN [] SQUALANE [] PROPYLENE GLYCOL STEARATE [] CAPRYLIC/CAPRIC TRIGLYCERIDE [] STEARIC ACID [] GLYCERIN [] KAOLIN [] BETA VULGARIS (BEET) ROOT EXTRACT [] HABERLEA RHODOPENSIS LEAF EXTRACT [] TAMARINDUS INDICA SEED GUM [] YEAST EXTRACT [] MAGNESIUM CHLORIDE [] SODIUM CHLORIDE [] ZINC CHLORIDE [] POTASSIUM CHLORIDE [] LYSINE [] TOCOPHEROL [] PANTHENOL [] POLYSORBATE 20 [] LECITHIN [] TROMETHAMINE [] XANTHAN GUM [] ASCORBYL PALMITATE [] RETINYL PALMITATE [] CAPRYLYL GLYCOL [] SIMETHICONE [] CETYL ALCOHOL [] HYDROGENATED LECITHIN [] MAGNESIUM ALUMINUM SILICATE [] ISOSTEARIC ACID [] HEXYLENE GLYCOL [] PENTYLENE GLYCOL [] DISODIUM EDTA [] POTASSIUM SORBATE [] PHENOXYETHANOL []  [+/- MICA [] TITANIUM DIOXIDE (CI 77891) [] IRON OXIDES (CI 77491, CI 77492, CI 77499) [] CHROMIUM OXIDE GREENS (CI 77288)]

  • WARNINGS

    WARNING: KEEP OUT OF EYES. DISCONTINUE USE IF IRRITATION OCCURS. KEEP OUT OF REACH OF CHILDREN

  • PRINCIPAL DISPLAY PANEL


    PRINCIPAL DISPLAY PANEL:

    MAC

    SATINFINISH SPF 15

    FOUNDATION



    30 ML/1 FL OZ

    DISTR BY MAKE-UP ART COSMETICS
    TORONTO, ONTARIO, CANADA, M5V 1R7

    FOLDING CARTON





  • INGREDIENTS AND APPEARANCE
    MINERALIZE  SATIN FOUNDATION SPF 15 FOUNDATION
    octinoxate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:40046-0042
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    SQUALANE (UNII: GW89575KF9)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    KAOLIN (UNII: 24H4NWX5CO)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    BEET (UNII: N487KM8COK)  
    YEAST (UNII: 3NY3SM6B8U)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ZINC CHLORIDE (UNII: 86Q357L16B)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    LYSINE (UNII: K3Z4F929H6)  
    ALPHA-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    TROMETHAMINE (UNII: 023C2WHX2V)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    2-OCTANOL (UNII: 66B0DD5E40)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    MICA (UNII: V8A1AW0880)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:40046-0042-11 in 1 CARTON
    1NDC:40046-0042-230 mL in 1 BOTTLE, GLASS
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35209/01/2006
    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
    Establishment
    NameAddressID/FEIBusiness Operations
    MANA COSMETICS INC078870292manufacture