LA MER THE LUMINOUS LIFTING CUSHION FOUNDATION BROAD SPECTRUM SPF 20 (TITANIUM DIOXIDE) LOTION [MAX HUBER RESEARCH LAB INC]

LA MER THE LUMINOUS LIFTING CUSHION FOUNDATION BROAD SPECTRUM SPF 20 (TITANIUM DIOXIDE) LOTION [MAX HUBER RESEARCH LAB INC]
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NDC 65966-019-01
Set ID 66e48ce0-9a5b-4250-b07b-1622b3814c3e
Category HUMAN OTC DRUG LABEL
Packager MAX HUBER RESEARCH LAB INC
Generic Name
Product Class
Product Number
Application Number PART352
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Titanium Dioxide 6.5%

  • Purpose

    Sunscreen

  • Uses

    helps prevent sunburn

  • Warnings

    For external use only

    Do not use on damaged or broken skin

    When using this product keep out of eyes. Rinse with water to remove.

    Stop use and ask a doctor if rash occurs

    Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    For sunscreen use:

    • apply liberally 15 minutes before sun exposure
    • reapply at least every two hours
    • use a water resistant sunscreen if swimming or sweating
    • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
      limit time in the sun, especially from 10 a.m. – 2 p.m.
      wear long-sleeved shirts, pants, hats and sunglasses
    • children under 6 months of age: ask a doctor
  • Inactive Ingredients

    WATER\AQUA\EAU • BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE • DIMETHICONE • METHYL TRIMETHICONE • DIPHENYLSILOXY PHENYL TRIMETHICONE • LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE • GLYCERIN • BUTYLENE GLYCOL • PENTYLENE GLYCOL • PEG-10 DIMETHICONE • ALGAE (SEAWEED) EXTRACT • SESAMUM INDICUM (SESAME) SEED OIL • MEDICAGO SATIVA (ALFALFA) SEED POWDER • HELIANTHUS ANNUUS (SUNFLOWER) SEEDCAKE • PRUNUS AMYGDALUS DULCIS (SWEET ALMOND) SEED MEAL • EUCALYPTUS GLOBULUS (EUCALYPTUS) LEAF OIL • SODIUM GLUCONATE • COPPER GLUCONATE • CALCIUM GLUCONATE • MAGNESIUM GLUCONATE • ZINC GLUCONATE • TOCOPHERYL SUCCINATE • NIACIN • SESAMUM INDICUM (SESAME) SEED POWDER • CITRUS AURANTIFOLIA (LIME) PEEL EXTRACT • CODIUM TOMENTOSUM EXTRACT • ERYNGIUM MARITIMUM EXTRACT • LAMINARIA DIGITATA EXTRACT • SIGESBECKIA ORIENTALIS (ST. PAUL'S WORT) EXTRACT • ACETYL HEXAPEPTIDE-8 • MAGNESIUM SULFATE • ACRYLATES/STEARYL ACRYLATE/DIMETHICONE METHACRYLATE COPOLYMER • DIMETHICONE CROSSPOLYMER • DISTEARDIMONIUM HECTORITE • LAUROYL LYSINE • ETHYLHEXYLGLYCERIN • POLYHYDROXYSTEARIC ACID • YEAST EXTRACT\FAEX\EXTRAIT DE LEVURE • CAPRYLYL GLYCOL • LECITHIN • ISOPROPYL MYRISTATE • ISOSTEARIC ACID • ETHYLHEXYL PALMITATE • STEARIC ACID • POLYGLYCERYL-3 POLYRICINOLEATE • ALUMINA • ALUMINUM HYDROXIDE • TOCOPHEROL • TRIETHOXYCAPRYLYLSILANE • FRAGRANCE (PARFUM) • POTASSIUM SORBATE • ALCOHOL DENAT. • DISODIUM EDTA • BHT • LINALOOL • CITRONELLOL • GERANIOL • LIMONENE • HYDROXYCITRONELLAL • PHENOXYETHANOL • [+/- MICA • TITANIUM DIOXIDE (CI 77891) • IRON OXIDES (CI 77492) • IRON OXIDES (CI 77491) • IRON OXIDES (CI 77499)] <ILN44570>

  • Other information

    • protect the product in this container from excessive heat and direct sun
  • PRINCIPAL DISPLAY PANEL - 12 g x 2 Container Carton

    SKINCOLOR DE LA MER™

    LA MER

    the luminous lifting cushion foundation
    broad spectrum SPF 20

    total poids net wt. 0.84 oz./24g e (12g x 2)

    PRINCIPAL DISPLAY PANEL - 12 g x 2 Container Carton
  • INGREDIENTS AND APPEARANCE
    LA MER THE LUMINOUS LIFTING CUSHION FOUNDATION BROAD SPECTRUM SPF 20 
    titanium dioxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65966-019
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide6.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    METHYL TRIMETHICONE (UNII: S73ZQI0GXM)  
    DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)  
    LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    SESAME OIL (UNII: QX10HYY4QV)  
    ALFALFA SEED (UNII: 67PHZ58858)  
    HELIANTHUS ANNUUS SEEDCAKE (UNII: 482WYF7XLC)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    SODIUM GLUCONATE (UNII: R6Q3791S76)  
    COPPER GLUCONATE (UNII: RV823G6G67)  
    CALCIUM GLUCONATE (UNII: SQE6VB453K)  
    MAGNESIUM GLUCONATE (UNII: T42NAD2KHC)  
    ZINC GLUCONATE (UNII: U6WSN5SQ1Z)  
    .ALPHA.-TOCOPHEROL SUCCINATE, D- (UNII: LU4B53JYVE)  
    NIACIN (UNII: 2679MF687A)  
    LIME PEEL (UNII: 544EQK5Q0W)  
    CODIUM TOMENTOSUM (UNII: B8B45BRU87)  
    ERYNGIUM MARITIMUM (UNII: PW58525THK)  
    LAMINARIA DIGITATA (UNII: 15E7C67EE8)  
    ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    LAUROYL LYSINE (UNII: 113171Q70B)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    ALCOHOL (UNII: 3K9958V90M)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    GERANIOL (UNII: L837108USY)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    MICA (UNII: V8A1AW0880)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65966-019-012 in 1 CARTON07/01/2018
    112 g in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35207/01/2018
    Labeler - MAX HUBER RESEARCH LAB INC (926708694)
    Establishment
    NameAddressID/FEIBusiness Operations
    ESTEE LAUDER COMPANY, THE828534516RELABEL(65966-019) , REPACK(65966-019)
    Establishment
    NameAddressID/FEIBusiness Operations
    ESTEE LAUDER COSMETICS, LTD244669714MANUFACTURE(65966-019)
    Establishment
    NameAddressID/FEIBusiness Operations
    ESTEE LAUDER COSMETICS, LTD.202952982MANUFACTURE(65966-019)
    Establishment
    NameAddressID/FEIBusiness Operations
    ESTEE LAUDER N.V.370151326MANUFACTURE(65966-019)
    Establishment
    NameAddressID/FEIBusiness Operations
    LEN-RON MANUFACTURING DIVISION OF ARAMIS INC809771152MANUFACTURE(65966-019)
    Establishment
    NameAddressID/FEIBusiness Operations
    NORTHTEC INC943871157RELABEL(65966-019) , REPACK(65966-019)
    Establishment
    NameAddressID/FEIBusiness Operations
    NORTHTEC LLC959338336MANUFACTURE(65966-019)
    Establishment
    NameAddressID/FEIBusiness Operations
    PADC 1949264774RELABEL(65966-019) , REPACK(65966-019)
    Establishment
    NameAddressID/FEIBusiness Operations
    WHITMAN LABORATORIES, LTD.216866277MANUFACTURE(65966-019)
    Establishment
    NameAddressID/FEIBusiness Operations
    ESTEE LAUDER COSMETICS, LTD255175580MANUFACTURE(65966-019)
    Establishment
    NameAddressID/FEIBusiness Operations
    COSMAX INC.689049693MANUFACTURE(65966-019)

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