RESILIENCE LIFT EXTREME ULTRA FIRMING SPF 15- octinoxate, octisalate cream

RESILIENCE LIFT by

Drug Labeling and Warnings

RESILIENCE LIFT by is a Otc medication manufactured, distributed, or labeled by ESTEE LAUDER INC, ESTEE LAUDER COSMETICS, LTD, ESTEE LAUDER N.V., Len-Ron Manufacturing Division of Aramis Inc., Aramis Inc., Northtec Bristol, Northtec Keystone, Estee Lauder Pennsylvania Distribution Center 2, Estee Lauder Cosmetics, Ltd., Estee Lauder Cosmetics, Ltd, Estee Lauder Cosmetics Distribution Center, Estee Lauder Kabushiki Kaisha, Whitman Laboratories Ltd., Aveda Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENTS: OCTINOXATE 7.50% [] OCTISALATE 3.50%

INACTIVE INGREDIENT

INACTIVE INGREDIENTS: WATER [] NEOPENTYL GLYCOL DIHEPTANOATE [] CETYL ALCOHOL [] GLYCERIN [] POLYETHYLENE [] DI-C12-15 ALKYL FUMARATE [] PETROLATUM [] HYDROGENATED LECITHIN [] BUTYLENE GLYCOL [] PENTYLENE GLYCOL [] OCTYLDODECYL MYRISTATE [] ISOCETYL ALCOHOL [] HYDROGENATED POLYISOBUTENE [] HEXYLDECYL STEARATE [] PENTAERYTHRITYL TETRAETHYLHEXANOATE [] BEHENYL ALCOHOL [] POTATO STARCH MODIFIED [] ALGAE EXTRACT [] OLEA EUROPAEA (OLIVE) FRUIT EXTRACT [] PERSEA GRATISSIMA (AVOCADO) OIL [] TRITICUM VULGARE (WHEAT BRAN) EXTRACT [] COLEUS BARBATUS EXTRACT [] CUCUMIS MELO (MELON) FRUIT EXTRACT [] ISOMERIZED LINOLEIC ACID [] DIMETHICONE [] MIMOSA TENUIFLORA BARK EXTRACT [] YEAST EXTRACT\FAEX\EXTRAIT DE LEVURE [] AMINOPROPYL ASCORBYL PHOSPHATE [] THERMUS THERMOPHILLUS FERMENT [] C12-16 ALCOHOLS [] GLYCERYL STEARATE [] CHOLESTEROL/POTASSIUM SULFATE [] OCTYLDODECYL NEOPENTANOATE [] ACETYL GLUCOSAMINE [] LINOLEIC ACID [] PEG-100 STEARATE [] CAFFEINE [] GLYCINE SOJA (SOYBEAN) STEROLS [] PALMITIC ACID [] POLYMETHYL METHACRYLATE [] PRUNUS AMYGDALUS DULCIS (SWEET ALMOND) SEED EXTRACT [] SODIUM HYALURONATE [] DECARBOXY CARNOSINE HCL [] ADENOSINE PHOSPHATE [] POTASSIUM SORBATE [] CREATINE [] TREHALOSE [] SORBITOL [] POLYSILICONE-11 [] ACETYL HEXAPEPTIDE-8 [] PROPYLENE GLYCOL DICAPRYLATE [] HYDROLYZED FISH (PISCES) COLLAGEN [] LECITHIN [] HYDROXYETHYLCELLULOSE [] MALTODEXTRIN [] HEXYLENE GLYCOL [] LAURDIMONIUM HYDROXYPROPYL HYDROLYZED SOY PROTEIN [] SODIUM STEARATE [] SODIUM CITRATE [] ALUMINUM STEARATE [] CAPRYLYL GLYCOL [] FRAGRANCE (PARFUM) [] XANTHAN GUM [] DISODIUM EDTA [] PHENOXYETHANOL [] MICA [] TITANIUM DIOXIDE (CI 77891) [] RED 4 (CI 14700) [] YELLOW 5 (CI 19140)

WARNINGS

WARNING: KEEP OUT OF EYES. STOP USE IF IRRITATION OCCURS. KEEP OUT OF REACH OF CHILDREN.

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL:

ESTEE LAUDER

RESILIENCE LIFT EXTREME

ULTRA FIRMING CREME

SPF 15

NORMAL/COMBINATION SKIN

NT WT. 1.7 OZ./50 ML

ESTEE LAUDER INC DIST

NEW YORK, NY 10022

INGREDIENTS AND APPEARANCE

RESILIENCE LIFT  EXTREME ULTRA FIRMING SPF 15
octinoxate, octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11559-932
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 mL  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	3.5 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCERIN (UNII: PDC6A3C0OX)
PETROLATUM (UNII: 4T6H12BN9U)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
OCTYLDODECYL MYRISTATE (UNII: S013N99GR8)
ISOCETYL ALCOHOL (UNII: 1800H64066)
DOCOSANOL (UNII: 9G1OE216XY)
STARCH, POTATO (UNII: 8I089SAH3T)
OLIVE OIL (UNII: 6UYK2W1W1E)
AVOCADO OIL (UNII: 6VNO72PFC1)
WHEAT BRAN (UNII: 6L966A1IMR)
PLECTRANTHUS BARBATUS ROOT (UNII: V5741391RG)
CUCUMBER (UNII: YY7C30VXJT)
DIMETHICONE (UNII: 92RU3N3Y1O)
ALBIZIA JULIBRISSIN BARK (UNII: 0J9G6W44DV)
YEAST (UNII: 3NY3SM6B8U)
C12-16 ALCOHOLS (UNII: S4827SZE3L)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
CHOLESTEROL (UNII: 97C5T2UQ7J)
POTASSIUM SULFATE (UNII: 1K573LC5TV)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
LINOLEIC ACID (UNII: 9KJL21T0QJ)
PEG-100 STEARATE (UNII: YD01N1999R)
CAFFEINE (UNII: 3G6A5W338E)
SOY STEROL (UNII: PL360EPO9J)
PALMITIC ACID (UNII: 2V16EO95H1)
ALMOND OIL (UNII: 66YXD4DKO9)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
ADENOSINE PHOSPHATE (UNII: 415SHH325A)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
CREATINE (UNII: MU72812GK0)
TREHALOSE (UNII: B8WCK70T7I)
SORBITOL (UNII: 506T60A25R)
ACETYL HEXAPEPTIDE-3 (UNII: L4EL31FWIL)
PROPYLENE GLYCOL DICAPRYLATE (UNII: 581437HWX2)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
MICA (UNII: V8A1AW0880)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11559-932-01	1 in 1 CARTON
1	NDC: 11559-932-02	50 mL in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	05/01/2008

Labeler - ESTEE LAUDER INC (005914387)

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
Aramis Inc.		042918826	manufacture

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
Estee Lauder Pennsylvania Distribution Center 2		828534516	manufacture, relabel, repack

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Cosmetics, Ltd.		255175580	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Cosmetics, Ltd		253616536	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 Kabushiki Kaisha		712808195	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