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

LA MER THE RADIANT SKINTINT BROAD SPECTRUM SPF 30 by

Drug Labeling and Warnings

LA MER THE RADIANT SKINTINT BROAD SPECTRUM SPF 30 by is a Otc medication manufactured, distributed, or labeled by MAX HUBER RESEARCH LAB INC, Estee Lauder Companies Inc., PALC, Estee Lauder Cosmetics Ltd., Whitman Laboratories Ltd., Estee Lauder N.V., The Estee Lauder Inc, Northtec LLC, PADC 1. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65966-021
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	82.5 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	22 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	58.3 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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)
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)
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)
ZEOLITE A (UNII: Y3NG9WF08W)
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)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICA (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65966-021-01	1 in 1 CARTON	02/26/2020
1		40 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	02/26/2020

Labeler - MAX HUBER RESEARCH LAB INC (926708694)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(65966-021) , REPACK(65966-021)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(65966-021)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(65966-021)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(65966-021)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(65966-021)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC INC		943871157	RELABEL(65966-021) , REPACK(65966-021)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	RELABEL(65966-021) , REPACK(65966-021)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(65966-021)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(65966-021)