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)

PRINCIPAL DISPLAY PANEL - 12 g x 2 Container Carton

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

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

Ingredient Name	Strength
Inactive Ingredients
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)
YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
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 WHOLE (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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	M020	07/01/2018

Labeler - MAX HUBER RESEARCH LAB INC (926708694)

Registrant - Estee Lauder Companies Inc. (790802086)

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