LA MER THE LUMINOUS LIFTING CUSHION FOUNDATION BROAD SPECTRUM SPF 20- titanium dioxide lotion

LA MER THE LUMINOUS LIFTING CUSHION FOUNDATION BROAD SPECTRUM SPF 20 by

Drug Labeling and Warnings

LA MER THE LUMINOUS LIFTING CUSHION FOUNDATION BROAD SPECTRUM SPF 20 by is a Otc medication manufactured, distributed, or labeled by MAX HUBER RESEARCH LAB INC, ESTEE LAUDER COMPANY, THE, ESTEE LAUDER COSMETICS, LTD, ESTEE LAUDER COSMETICS, LTD., ESTEE LAUDER N.V., LEN-RON MANUFACTURING DIVISION OF ARAMIS INC, NORTHTEC INC, PADC 1, WHITMAN LABORATORIES, LTD., COSMAX INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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)

INGREDIENTS AND APPEARANCE

LA MER THE LUMINOUS LIFTING CUSHION FOUNDATION BROAD SPECTRUM SPF 20 
titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65966-019
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	6.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65966-019-01	2 in 1 CARTON	07/01/2018
1		12 g in 1 CONTAINER; 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	07/01/2018

Labeler - MAX HUBER RESEARCH LAB INC (926708694)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(65966-019) , REPACK(65966-019)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(65966-019)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(65966-019)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(65966-019)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(65966-019)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC INC		943871157	RELABEL(65966-019) , REPACK(65966-019)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	RELABEL(65966-019) , REPACK(65966-019)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(65966-019)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(65966-019)

Establishment
Name	Address	ID/FEI	Business Operations
COSMAX INC.		689049693	MANUFACTURE(65966-019)