THE SOF FLUID LONG WEAR FOUNDATION BROAD SPECTRUM SPF 20- octinoxate and titanium dioxide liquid

THE SOF FLUID LONG WEAR FOUNDATION BROAD SPECTRUM SPF 20 by

Drug Labeling and Warnings

THE SOF FLUID LONG WEAR FOUNDATION BROAD SPECTRUM SPF 20 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%
Titanium dioxide 1.9%

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

DECLUSTERED WATER (-)\AQUA\EAU DE-STRUCTUREE (-) DECLUSTERED WATER (+)\AQUA\EAU DE-STRUCTUREE (+) CYCLOPENTASILOXANE ISODODECANE DIMETHICONE PHENYL TRIMETHICONE BUTYLENE GLYCOL POLYMETHYL METHACRYLATE POLYSILICONE-11 COCO-CAPRYLATE/CAPRATE PEG/PPG-18/18 DIMETHICONE OCTYLDODECYL NEOPENTANOATE SILICA 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 POLYGLYCERYL-4 ISOSTEARATE CITRUS AURANTIFOLIA (LIME) PEEL EXTRACT CHONDRUS CRISPUS (CARRAGEENAN) EXTRACT CUCUMIS SATIVUS (CUCUMBER) FRUIT EXTRACT HORDEUM VULGARE (BARLEY) EXTRACT\EXTRAIT D'ORGE MOLASSES EXTRACT\SACCHARUM OFFICINARUM\EXTRAIT DE MELASSE CHLORELLA VULGARIS EXTRACT GELIDIUM CARTILAGINEUM EXTRACT CORALLINA OFFICINALIS EXTRACT SACCHAROMYCES LYSATE EXTRACT SILYBUM MARIANUM (LADY'S THISTLE) EXTRACT WHEY PROTEIN\LACTIS PROTEIN\PROTEINE DU PETIT-LAIT LAMINARIA SACCHARINA EXTRACT CODIUM TOMENTOSUM EXTRACT SUCROSE GLYCERIN CHOLESTEROL ERYNGIUM MARITIMUM EXTRACT LAMINARIA DIGITATA EXTRACT GLYCINE SOJA (SOYBEAN) PROTEIN ACETYL GLUCOSAMINE CAFFEINE SORBITOL SIGESBECKIA ORIENTALIS (ST. PAUL'S WORT) EXTRACT TOURMALINE ACETYL HEXAPEPTIDE-8 SODIUM HYALURONATE HEXYL LAURATE CETYL PEG/PPG-10/1 DIMETHICONE DISTEARDIMONIUM HECTORITE C12-16 ALCOHOLS MAGNESIUM ALUMINUM SILICATE TREHALOSE YEAST EXTRACT\FAEX\EXTRAIT DE LEVURE DIMETHICONE SILYLATE PROPYLENE GLYCOL DIETHYLHEXANOATE YEAST POLYSACCHARIDES CAPRYLYL GLYCOL TRIETHYL CITRATE TETRAHEXYLDECYL ASCORBATE STEARIC ACID PALMITIC ACID HYDROGENATED LECITHIN METHICONE PROPYLENE GLYCOL DICAPRATE TOCOPHERYL LINOLEATE/OLEATE SODIUM CHLORIDE ALUMINUM HYDROXIDE HEXYLENE GLYCOL TRIETHOXYCAPRYLYLSILANE FRAGRANCE (PARFUM) ALCOHOL DENAT. DISODIUM EDTA BHT PHENOXYETHANOL [+/- MICA TITANIUM DIOXIDE (CI 77891) IRON OXIDES (CI 77492) IRON OXIDES (CI 77491) IRON OXIDES (CI 77499)] <ILN42899>

Other information

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

PRINCIPAL DISPLAY PANEL - 30 ml Bottle Carton

SKINCOLOR DE LA MER™

LA MER

the soft fluid
long wear foundation
broad spectrum SPF 20

net wt. 1 oz./30 ml e

INGREDIENTS AND APPEARANCE

THE SOF FLUID LONG WEAR FOUNDATION BROAD SPECTRUM SPF 20 
octinoxate and titanium dioxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65966-018
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.0795 g  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.02014 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
ISODODECANE (UNII: A8289P68Y2)
DIMETHICONE (UNII: 92RU3N3Y1O)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
NORI (UNII: 477TV3P5UX)
SESAME OIL (UNII: QX10HYY4QV)
ALFALFA SEED (UNII: 67PHZ58858)
HELIANTHUS ANNUUS SEEDCAKE (UNII: 482WYF7XLC)
ALMOND (UNII: 3Z252A2K9G)
EUCALYPTUS OIL (UNII: 2R04ONI662)
SODIUM GLUCONATE (UNII: R6Q3791S76)
COPPER GLUCONATE (UNII: RV823G6G67)
CALCIUM GLUCONATE (UNII: SQE6VB453K)
MAGNESIUM GLUCONATE (UNII: T42NAD2KHC)
ZINC SUCCINATE (UNII: IY01B595GR)
.ALPHA.-TOCOPHEROL SUCCINATE, D- (UNII: LU4B53JYVE)
NIACIN (UNII: 2679MF687A)
SESAME SEED (UNII: 7Y1255HVXR)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
LIME PEEL (UNII: 544EQK5Q0W)
CHONDRUS CRISPUS CARRAGEENAN (UNII: UE856F2T78)
CUCUMBER (UNII: YY7C30VXJT)
HORDEUM VULGARE WHOLE (UNII: 8JBE478M5Q)
MOLASSES (UNII: LSU3YX0KZO)
CHLORELLA VULGARIS (UNII: RYQ4R60M02)
GELIDIUM CARTILAGINEUM (UNII: 37LBZ0E1UE)
CORALLINA OFFICINALIS (UNII: 4004498D06)
SACCHAROMYCES LYSATE (UNII: R85W246Z1C)
MILK THISTLE (UNII: U946SH95EE)
WHEY (UNII: 8617Z5FMF6)
SACCHARINA LATISSIMA (UNII: 68CMP2MB55)
CODIUM TOMENTOSUM (UNII: B8B45BRU87)
SUCROSE (UNII: C151H8M554)
GLYCERIN (UNII: PDC6A3C0OX)
CHOLESTEROL (UNII: 97C5T2UQ7J)
LAMINARIA DIGITATA (UNII: 15E7C67EE8)
SOY PROTEIN (UNII: R44IWB3RN5)
N-ACETYLGLUCOSAMINE (UNII: V956696549)
CAFFEINE (UNII: 3G6A5W338E)
SORBITOL (UNII: 506T60A25R)
ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
C12-16 ALCOHOLS (UNII: S4827SZE3L)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
TREHALOSE (UNII: B8WCK70T7I)
YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)
PROPYLENE GLYCOL DIETHYLHEXANOATE (UNII: 8D8I9Z0F1Z)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
STEARIC ACID (UNII: 4ELV7Z65AP)
PALMITIC ACID (UNII: 2V16EO95H1)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
METHICONE (20 CST) (UNII: 6777U11MKT)
PROPYLENE GLYCOL DICAPRATE (UNII: U783H9JHWY)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ALCOHOL (UNII: 3K9958V90M)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
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: 65966-018-01	1 in 1 CARTON	03/01/2016
1		30 mL in 1 BOTTLE; 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	03/01/2016

Labeler - MAX HUBER RESEARCH LAB INC (926708694)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(65966-018) , REPACK(65966-018)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(65966-018)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(65966-018)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(65966-018)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(65966-018)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC INC		943871157	RELABEL(65966-018) , REPACK(65966-018)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	RELABEL(65966-018) , REPACK(65966-018)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(65966-018)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(65966-018)