Label: LA MER THE SOFT MOISTURE FOUNDATION BROAD SPECTRUM SPF 30- octinoxate and titanium dioxide powder

  • NDC Code(s): 65966-020-01
  • Packager: MAX HUBER RESEARCH LAB INC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 August 21, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Octinoxate 5.1%
    Titanium Dioxide 6.0%

  • Purpose

    Sunscreen

  • Use

    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:
      • time in the sun, especially from 10 a.m. – 2 p.m.
      • long-sleeve shirts, pants, hats and sunglasses
    • children under 6 months of age: ask a doctor
  • Inactive ingredients

    TALC • SYNTHETIC FLUORPHLOGOPITE • METHYL METHACRYLATE CROSSPOLYMER • BORON NITRIDE • WATER\AQUA\EAU • VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER • DIMETHICONE • ALUMINUM HYDROXIDE • DIISOSTEARYL MALATE • ALGAE ( SEAWEED) E X TRACT • SESAMUM INDICUM (SESAME) SEED OIL • MEDICAGO SATIVA (ALFALFA) SEED POWDER • HELIANTHUS ANNUUS (SUNFLOWER) SEEDCAKE • PRUNUS AMYGDALUS DULCIS (SWEET ALMOND) SE ED ME A L • EUCA LY PT US G LOBULUS ( EUCA LY PT US ) L E A F O I L • SODIUM GLUCONAT E • COPPER GLUCONAT E • CALCIUM GLUCONAT E • MAGNESIUM GLUCONATE • ZINC GLUCONATE • TOCOPHERYL SUCCINATE • NIACIN • SESAMUM INDICUM (SESAME) SEED POWDER • CITRUS AURANTIFOLIA (LIME) PEEL EXTRACT • CODIUM TOMENTOSUM EXTRACT • HYDROLYZED CORALLINA OFFICINALIS • WHEY PROTEIN\LACTIS PROTEIN\PROTEINE DU PETIT-LAIT • ACETYL GLUCOSAMINE • ERYNGIUM MARITIMUM EXTRACT • LAMINARIA DIGITATA EXTRACT • GLYCERIN • ACET YL HEXAPEPTIDE-8 • BUT YLENE GLYCOL • HYDROLYZED RICE PROTEIN • SIGESBECKIA ORIENTALIS (ST. PAUL'S WORT) EXTRACT • YEAST EXTRACT\FAEX\EXTRAIT DE LEVURE • BARIUM SULFATE • ISOCETYL MYRISTATE • METHICONE • TETRAHEXYLDECYL ASCORBATE • SQUALANE • PHYTOSTERYL/ISOSTEARYL/CETYL/STEARYL/BEHENYL DIMER DILINOLEATE • POLYSORBATE 80 • CAPRYLYL GLYCOL • SILICA • HYDRATED SILICA • ALUMINUM DISTEARATE • HYDROGEN DIMETHICONE • TOCOPHEROL • FRAGRANCE (PARFUM) • BHT • ALCOHOL DENAT. • POTASSIUM SORBATE • SODIUM DEHYDROACETATE • PHENOXYETHANOL • [+/- MICA • TITANIUM DIOXIDE (CI 77891) • IRON OXIDES (CI 77491) • IRON OXIDES (CI 77492) • IRON OXIDES (CI 77499)] <ILN46686>

  • Other information

    protect the product in this container from excessive heat and direct sun

  • PRINCIPAL DISPLAY PANEL - 9.5 g Jar Carton

    SKINCOLOR DE LA MER™

    LA MER

    THE SOFT MOISTURE POWDER FOUNDATION
    BROAD SPECTRUM SPF 30

    net wt. 33 oz./9.5g e

    PRINCIPAL DISPLAY PANEL - 9.5 g Jar Carton
  • INGREDIENTS AND APPEARANCE
    LA MER THE SOFT MOISTURE FOUNDATION BROAD SPECTRUM SPF 30 
    octinoxate and titanium dioxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65966-020
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE5.1 g  in 100 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE6 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    TALC (UNII: 7SEV7J4R1U)  
    METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: 657L0NC5MT)  
    BORON NITRIDE (UNII: 2U4T60A6YD)  
    WATER (UNII: 059QF0KO0R)  
    VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
    NORI (UNII: 477TV3P5UX)  
    SESAME OIL (UNII: QX10HYY4QV)  
    ALFALFA SEED (UNII: 67PHZ58858)  
    HELIANTHUS ANNUUS SEEDCAKE (UNII: 482WYF7XLC)  
    EUCALYPTUS GUM (UNII: 72T9EZC2VX)  
    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)  
    SESAME SEED (UNII: 7Y1255HVXR)  
    LIME PEEL (UNII: 544EQK5Q0W)  
    CODIUM TOMENTOSUM (UNII: B8B45BRU87)  
    WHEY (UNII: 8617Z5FMF6)  
    N-ACETYLGLUCOSAMINE (UNII: V956696549)  
    LAMINARIA DIGITATA (UNII: 15E7C67EE8)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    ISOCETYL MYRISTATE (UNII: 69AX3BRR5N)  
    METHICONE (20 CST) (UNII: 6777U11MKT)  
    SQUALANE (UNII: GW89575KF9)  
    PHYTOSTERYL/ISOSTEARYL/CETYL/STEARYL/BEHENYL DIMER DILINOLEATE (UNII: 8N725H4EFN)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)  
    ALCOHOL (UNII: 3K9958V90M)  
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    MICA (UNII: V8A1AW0880)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FRAGRANCE LAVENDER & CHIA F-153480 (UNII: SXS9CO2TZK)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    SIGESBECKIA ORIENTALIS FLOWERING TOP (UNII: 6UL878YAR7)  
    DISINTEGRIN AND METALLOPROTEINASE DOMAIN-CONTAINING PROTEIN 11 (UNII: K5Z8ZN42OC)  
    ERYNGIUM MARITIMUM ROOT (UNII: OSE7C1M67D)  
    CORALLINA OFFICINALIS (UNII: 4004498D06)  
    ALMOND (UNII: 3Z252A2K9G)  
    FLUORBENSIDE (UNII: Q449322QX1)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65966-020-011 in 1 CARTON06/17/2019
    19.5 g in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM02006/17/2019
    Labeler - MAX HUBER RESEARCH LAB INC (926708694)
    Registrant - Estee Lauder Companies Inc. (790802086)
    Establishment
    NameAddressID/FEIBusiness Operations
    ASANUMA CORPORATION715464942manufacture(65966-020)
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