LA MER THE REPARATIVE SKIN TINT BROAD SPECTRUM SPF 30- octinoxate, octisalate, and titanium dioxide lotion 
MAX HUBER RESEARCH LAB INC

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.

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LA MER THE REPARATIVE SKIN TINT BROAD SPECTRUM SPF 30

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 • MAGNOLIA OFFICINALIS BARK EXTRACT • PEG-100 STEARATE • SCUTELLARIA BAICALENSIS ROOT EXTRACT • MORUS NIGRA (MULBERRY) ROOT EXTRACT • HYDROGENATED LECITHIN • CORALLINA OFFICINALIS EXTRACT • GELIDIUM CARTILAGINEUM EXTRACT • VITIS VINIFERA (GRAPE) FRUIT 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 • STEARIC ACID • HORDEUM VULGARE (BARLEY) EXTRACT\EXTRAIT D'ORGE • 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 77492) • IRON OXIDES (CI 77491) • IRON OXIDES (CI 77499) • MICA] <ILN41371>

Other information

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

PRINCIPAL DISPLAY PANEL - 40 mL Tube Carton

LA MER

the reparative skintint
broad spectrum spf 30

1.4 fl. oz. liq./40 ml e

Principal Display Panel - 40 mL Tube Carton
LA MER THE REPARATIVE SKIN TINT BROAD SPECTRUM SPF 30 
octinoxate, octisalate, and titanium dioxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65966-017
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.0825 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE0.022 g  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.053 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
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)  
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)  
SESAME SEED (UNII: 7Y1255HVXR)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
CUCUMBER (UNII: YY7C30VXJT)  
MAGNOLIA OFFICINALIS BARK (UNII: 5M609NV974)  
PEG-100 STEARATE (UNII: YD01N1999R)  
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)  
MORUS NIGRA ROOT (UNII: 033456LFG1)  
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
CORALLINA OFFICINALIS (UNII: 4004498D06)  
PLOCAMIUM CARTILAGINEUM (UNII: 37LBZ0E1UE)  
WINE GRAPE (UNII: 3GOV20705G)  
SACCHAROMYCES LYSATE (UNII: R85W246Z1C)  
MENTHA SPICATA (UNII: O2H83I4PUN)  
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)  
WHEY (UNII: 8617Z5FMF6)  
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)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
BARLEY (UNII: 5PWM7YLI7R)  
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 (UNII: 7FLD91C86K)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
GERANIOL (UNII: L837108USY)  
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
MICA (UNII: V8A1AW0880)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65966-017-011 in 1 CARTON02/10/2015
140 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35202/10/201511/16/2020
Labeler - MAX HUBER RESEARCH LAB INC (926708694)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COMPANY, THE828534516RELABEL(65966-017) , REPACK(65966-017)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD244669714MANUFACTURE(65966-017)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD.202952982MANUFACTURE(65966-017)
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder N.V.370151326MANUFACTURE(65966-017)
Establishment
NameAddressID/FEIBusiness Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC809771152MANUFACTURE(65966-017)
Establishment
NameAddressID/FEIBusiness Operations
NORTHTEC INC943871157RELABEL(65966-017) , REPACK(65966-017)
Establishment
NameAddressID/FEIBusiness Operations
PADC 1949264774RELABEL(65966-017) , REPACK(65966-017)
Establishment
NameAddressID/FEIBusiness Operations
WHITMAN LABORATORIES, LTD.216866277MANUFACTURE(65966-017)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD255175580MANUFACTURE(65966-017)

Revised: 11/2020
Document Id: c2b4f1cf-d606-48cb-853e-274e7af2c525
Set id: 0f427ae2-f806-4fe8-9bbe-6eb859cf0f21
Version: 4
Effective Time: 20201116
 
MAX HUBER RESEARCH LAB INC