Label: LA MER THE RADIANT SKINTINT BROAD SPECTRUM SPF 30- octinoxate, octisalate, and titanium dioxide cream

  • NDC Code(s): 65966-021-01, 65966-021-02
  • Packager: MAX HUBER RESEARCH LAB INC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 30, 2023

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    OCTINOXATE 7.5%
    OCTISALATE 2.0%
    TITANIUM DIOXIDE 5.3%

  • Purpose

    SUNSCREEN

  • Uses

    • helps prevent sunburn
    • if used as directed with other sun protection measures (see Directions) decreases the risk of skin cancer and early skin aging caused by the sun
  • 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 • OCTYLDODECYL NEOPENTANOATE • CETYL ALCOHOL • LAURETH-4 • ASCORBYL GLUCOSIDE • NEOPENTYL GLYCOL DIHEPTANOATE • 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 • POLYETHYLENE • HELICHRYSUM ARENARIUM (EVERLASTING) EXTRACT • CUCUMIS SATIVUS (CUCUMBER) FRUIT EXTRACT • PEG-100 STEARATE • HYDROGENATED LECITHIN • CORALLINA OFFICINALIS EXTRACT • GELIDIUM CARTILAGINEUM EXTRACT • SACCHAROMYCES LYSATE EXTRACT • MENTHA VIRIDIS (SPEARMINT) • PELARGONIUM GRAVEOLENS (GERANIUM) FLOWER OIL • LAMINARIA SACCHARINA EXTRACT • CITRUS GRANDIS (GRAPEFRUIT) PEEL OIL • LAMINARIA DIGITATA EXTRACT • METHYLDIHYDROJASMONATE • SIGESBECKIA ORIENTALIS (ST. PAUL'S WORT) EXTRACT • ACETYL HEXAPEPTIDE-8 • SUCROSE • GLYCERIN • GLYCYRRHETINIC ACID • CAFFEINE • PROPYLENE GLYCOL DIETHYLHEXANOATE • LECITHIN • ISOHEXADECANE • POLYGLYCERYL-3 BEESWAX • WHEY PROTEIN\LACTIS PROTEIN\PROTEINE DU PETIT-LAIT • DIMETHOXYTOLYL PROPYLRESORCINOL • CITRUS AURANTIFOLIA (LIME) PEEL EXTRACT • ACETYL GLUCOSAMINE • PVP/HEXADECENE COPOLYMER • TOURMALINE • YEAST POLYSACCHARIDES • CAPRYLYL GLYCOL • ROSA DAMASCENA (ROSE) FLOWER OIL • YEAST EXTRACT\FAEX\EXTRAIT DE LEVURE • ISOSTEARIC ACID • PROPYLENE GLYCOL DICAPRATE • HORDEUM VULGARE (BARLEY) EXTRACT\EXTRAIT D'ORGE • STEARIC ACID • TROMETHAMINE • ACRYLAMIDE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER • GALACTOARABINAN • NYLON-12 • ZEOLITE • SYNTHETIC FLUORPHLOGOPITE • TOCOPHERYL LINOLEATE/OLEATE • SODIUM HYALURONATE • BORON NITRIDE • XANTHAN GUM • POLYSORBATE 80 • SILICA • ALUMINUM HYDROXIDE • ALCOHOL DENAT. • TIN OXIDE • DISODIUM EDTA • BHT • LINALOOL • GERANIOL • CITRONELLOL • LIMONENE • PHENOXYETHANOL • [+/- TITANIUM DIOXIDE (CI 77891) • IRON OXIDES (CI 77491) • IRON OXIDES (CI 77492) • IRON OXIDES (CI 77499) • MICA] <ILN45014>

  • Other information

    • protect the product in this container from excessive heat and direct sun
  • PRINCIPAL DISPLAY PANEL - 40 ml Tube Carton

    SKINCOLOR DE LA MER™

    LA MER

    THE RADIANT SKINTINT
    BROAD SPECTRUM SPF 30

    1.4 fl. oz. liq. /40 ml e

    PRINCIPAL DISPLAY PANEL - 40 ml Tube Carton
  • INGREDIENTS AND APPEARANCE
    LA MER THE RADIANT SKINTINT BROAD SPECTRUM SPF 30 
    octinoxate, octisalate, and titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65966-021
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE20 mg  in 1 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE53 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    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)  
    WATER (UNII: 059QF0KO0R)  
    NIACIN (UNII: 2679MF687A)  
    SESAME SEED (UNII: 7Y1255HVXR)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    GAMOCHAETA PURPUREA FLOWER (UNII: KQV867ADR4)  
    CUCUMBER (UNII: YY7C30VXJT)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    CORALLINA OFFICINALIS (UNII: 4004498D06)  
    PLOCAMIUM CARTILAGINEUM (UNII: 37LBZ0E1UE)  
    SACCHAROMYCES LYSATE (UNII: R85W246Z1C)  
    SPEARMINT (UNII: J7I2T6IV1N)  
    PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)  
    SACCHARINA LATISSIMA (UNII: 68CMP2MB55)  
    CITRUS MAXIMA FRUIT RIND OIL (UNII: 8U3877WD44)  
    LAMINARIA DIGITATA (UNII: 15E7C67EE8)  
    METHYL DIHYDROJASMONATE (SYNTHETIC) (UNII: 3GW44CIE3Y)  
    ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL)  
    SUCROSE (UNII: C151H8M554)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ENOXOLONE (UNII: P540XA09DR)  
    CAFFEINE (UNII: 3G6A5W338E)  
    PROPYLENE GLYCOL DIETHYLHEXANOATE (UNII: 8D8I9Z0F1Z)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    DIMETHOXYTOLYL PROPYLRESORCINOL (UNII: 4OD5GIH1UK)  
    LIME PEEL (UNII: 544EQK5Q0W)  
    N-ACETYLGLUCOSAMINE (UNII: V956696549)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ROSA X DAMASCENA FLOWER OIL (UNII: 18920M3T13)  
    YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    PROPYLENE GLYCOL DICAPRATE (UNII: U783H9JHWY)  
    BARLEY (UNII: 5PWM7YLI7R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TROMETHAMINE (UNII: 023C2WHX2V)  
    GALACTOARABINAN (UNII: SL4SX1O487)  
    NYLON-12 (UNII: 446U8J075B)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    BORON NITRIDE (UNII: 2U4T60A6YD)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    ALCOHOL (UNII: 3K9958V90M)  
    STANNIC OXIDE (UNII: KM7N50LOS6)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    GERANIOL (UNII: L837108USY)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    MICA (UNII: V8A1AW0880)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    LAURETH-4 (UNII: 6HQ855798J)  
    ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)  
    NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
    NORI (UNII: 477TV3P5UX)  
    SESAME OIL (UNII: QX10HYY4QV)  
    ALFALFA SEED (UNII: 67PHZ58858)  
    HELIANTHUS ANNUUS SEEDCAKE (UNII: 482WYF7XLC)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65966-021-011 in 1 CARTON02/26/2020
    140 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:65966-021-023 mL in 1 PACKET; Type 0: Not a Combination Product03/02/202210/30/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02002/26/2020
    Labeler - MAX HUBER RESEARCH LAB INC (926708694)
    Registrant - Estee Lauder Companies Inc. (790802086)
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder N.V.370151326manufacture(65966-021) , pack(65966-021) , label(65966-021)