RESILIENCE LIFT EXTREME- octinoxate and titanium dioxide liquid

Resilience Lift Extreme by

Drug Labeling and Warnings

Resilience Lift Extreme by is a Otc medication manufactured, distributed, or labeled by Estee Lauder Inc., ELGC Kabushiki Kaisha, Estee Lauder Pennsylvania Distribution Center 2 (PADC 2), ARAMIS, INC, ESTEE LAUDER COSMETICS DISTRIBUTION CENTER, ESTEE LAUDER COSMETICS, LTD, ESTEE LAUDER COSMETICS, LTD., ESTEE LAUDER N.V., LEN-RON MANUFACTURING DIVISION OF ARAMIS INC, NORTEC KEYSTONE, NORTHTEC BRISTOL, NORTHTEC KEYSTONE, WHITMAN LABORATORIES, LTD., Aveda Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

OCTINOXATE 4.20% TITANIUM DIOXIDE 1.00%

INGREDIENTS

WATER DIMETHICONE PHENYL TRIMETHICONE OCTYLDODECYL STEAROYL STEARATE BUTYLENE GLYCOL CETYL DIMETHICONE SILICA STEARETH-21 ISOSTEARIC ACID STEARIC ACID TROMETHAMINE GLYCERYL STEARATE HEXYLENE GLYCOL SIGESBECKIA ORIENTALIS (ST. PAUL'S WORT) EXTRACT COLEUS BARBATUS EXTRACT PISUM SATIVUM (PEA) EXTRACT MIMOSA TENUIFLORA BARK EXTRACT GLYCERETH-26 PERSEA GRATISSIMA (AVOCADO) OIL CUCUMIS MELO (MELON) FRUIT EXTRACT ASTROCARYUM MURUMURU SEED BUTTER HYDROLYZED WHEAT PROTEIN ACETYL GLUCOSAMINE CERAMIDE 3 CHOLESTEROL CYCLOPENTASILOXANE AMINOPROPYL ASCORBYL PHOSPHATE CHOLESTEROL/POTASSIUM SULFATE BENHENYL ALCOHOL POLYGLYCERYL-10 PENTASTEARATE GLYCERIN POLYSILICONE-11 PRUNUS AMYGDALUS DULCIS (SWEET ALMOND) SEED EXTRACT DIMETHICONE CROSSPOLYMER-3 ETHYLHEXYLGLYCERIN TOCOPHERYL ACETATE SODIUM HYALURONATE STEARETH-2 LINOLEIC ACID METHYL METHACRYLATE CROSSPOLYMER LECITHIN HYDROGENATED LECITHIN CAFFEINE MAGNESIUM ALUMINUM SILICATE CELLULOSE GUM ACETYL HEXAPEPTIDE-8 SODIUM STEAROL LACTYLATE PALMITOYL OLIGOPEPTIDE PALMITOYL TETRAPEPTIDE-7 HYDROLYZED FISH (PISCES) COLLAGEN LAURDIMONIUM HYDROXYPROPYL HYDROLYZED SOY PROTEIN YEAST EXTRACT CREATINE ADENOSINE PHOSPHATE CAPRYLOYL GLYCINE PEG-12 DIMETHICONE GLYCERYL POLYMETHACRYLATE MALTODEXTRIN PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE CAPRYLYL GLYCOL PROPYLENE GLYCOL DICAPRYLATE PEG-8 SODIUM CHLORIDE CARBOMER POLYSORBATE 20 HYDROXYETHYLCELLULOSE XANTHAN GUM ALUMINUM STEARATE DISODIUM EDTA POTASSIUM SORBATE PHENOXYETHANOL CHLOROXYLENOL [+/- TITANIUM DIOXIDE (CI 77891) MICA IRON OXIDES (CI 77491, CI 77492, CI 77499)]

WARNING

Keep out of eyes.

Stop use if irritation occurs.

Keep out of reach of children.

PRINCIPAL DISPLAY PANEL - 30 ml Carton

ESTĒE LAUDER

Resilience Lift
Extreme
Radiant Lifting Makeup
SPF15

1 FL. OZ. LIQ./30 ml e

INGREDIENTS AND APPEARANCE

RESILIENCE LIFT EXTREME   RADIANT LIFTING MAKEUP SPF 15
octinoxate and titanium dioxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11559-967
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	4.2 mL  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
OCTYLDODECYL STEAROYL STEARATE (UNII: 3D47Q6D93C)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARETH-21 (UNII: 53J3F32P58)
ISOSTEARIC ACID (UNII: X33R8U0062)
STEARIC ACID (UNII: 4ELV7Z65AP)
TROMETHAMINE (UNII: 023C2WHX2V)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
PEA (UNII: W4X7H8GYFM)
MIMOSA TENUIFLORA BARK (UNII: 515MQE449I)
GLYCERETH-26 (UNII: NNE56F2N14)
AVOCADO OIL (UNII: 6VNO72PFC1)
MUSKMELON (UNII: ZV095H5633)
ASTROCARYUM MURUMURU SEED BUTTER (UNII: 12V64UPU6R)
N-ACETYLGLUCOSAMINE (UNII: V956696549)
CERAMIDE 3 (UNII: 4370DF050B)
CHOLESTEROL (UNII: 97C5T2UQ7J)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DOCOSANOL (UNII: 9G1OE216XY)
GLYCERIN (UNII: PDC6A3C0OX)
ALMOND (UNII: 3Z252A2K9G)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
STEARETH-2 (UNII: V56DFE46J5)
LINOLEIC ACID (UNII: 9KJL21T0QJ)
CAFFEINE (UNII: 3G6A5W338E)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN)
PALMITOYL OLIGOPEPTIDE (UNII: HO4ZT5S86C)
PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)
YEAST (UNII: 3NY3SM6B8U)
CREATINE (UNII: MU72812GK0)
ADENOSINE PHOSPHATE (UNII: 415SHH325A)
CAPRYLOYL GLYCINE (UNII: 8TY5YO42NJ)
PEG-12 DIMETHICONE (UNII: ZEL54N6W95)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
PROPYLENE GLYCOL DICAPRYLATE (UNII: 581437HWX2)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
XANTHAN GUM (UNII: TTV12P4NEE)
ALUMINUM STEARATE (UNII: U6XF9NP8HM)
EDETATE DISODIUM (UNII: 7FLD91C86K)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CHLOROXYLENOL (UNII: 0F32U78V2Q)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11559-967-01	1 in 1 CARTON
1		30 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	06/01/2006

Labeler - Estee Lauder Inc. (005914387)

Establishment
Name	Address	ID/FEI	Business Operations
ELGC Kabushiki Kaisha		712808195	RELABEL, REPACK

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Pennsylvania Distribution Center 2 (PADC 2)		828534516	MANUFACTURE, RELABEL, REPACK

Establishment
Name	Address	ID/FEI	Business Operations
ARAMIS, INC		042918826	MANUFACTURE

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS DISTRIBUTION CENTER		208579636	REPACK, RELABEL

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		253616536	MANUFACTURE

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		205952385	MANUFACTURE

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE

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

Establishment
Name	Address	ID/FEI	Business Operations
NORTEC KEYSTONE		787336577	MANUFACTURE, RELABEL, REPACK

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC BRISTOL		949264774	MANUFACTURE, RELABEL, REPACK

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC KEYSTONE		618107429	MANUFACTURE, RELABEL, REPACK

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE

Establishment
Name	Address	ID/FEI	Business Operations
Aveda Corporation		071352058	MANUFACTURE