VITAMIN E DAY SPF 15- octisalate, avobenzone cream

VITAMIN E DAY by

Drug Labeling and Warnings

VITAMIN E DAY by is a Otc medication manufactured, distributed, or labeled by JO MALONE LTD, 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: OCTISALATE 5.00% [] AVOBENZONE 3.00%

INACTIVE INGREDIENT

INGREDIENTS: WATER [] DIMETHICONE [] BUTYLOCTYL SALICYLATE [] BUTYLENE GLYCOL [] POLYESTER-8 [] CETYL RICINOLEATE [] STEARETH-21 [] STEARETH-2 [] DI-C12-15 ALKYL FUMARATE [] CAPRYLIC/CAPRIC/MYRISTIC/STEARIC TRIGLYCERIDE [] POLYSILICONE-11 [] GENTIANA LUTEA (GENTIAN) ROOT EXTRACT [] POLYGONUM CUSPIDATUM ROOT EXTRACT [] HORDEUM VULGARE (BARLEY) EXTRACT\EXTRAIT D'ORGE [] TRITICUM VULGARE (WHEAT) GERM EXTRACT [] LAMINARIA OCHROLEUCA EXTRACT [] HYDROLYZED RICE EXTRACT [] FUMARIA OFFICINALIS FLOWER/LEAF/STEM EXTRACT [] CITRUS MEDICA LIMONUM (LEMON) FRUIT EXTRACT [] HYDROLYZED RICE BRAN EXTRACT [] ROSMARINUS OFFICINALIS (ROSEMARY) LEAF EXTRACT [] VITIS VINIFERA (GRAPE) SEED EXTRACT [] ARTEMIA EXTRACT [] THERMUS THERMOPHILLUS FERMENT [] STEARYL ALCOHOL [] PENTYLENE GLYCOL [] POLYQUATERNIUM-51 [] LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE [] BEHENYL ALCOHOL [] TRIACONTANYL PVP [] GLYCERIN [] LECITHIN [] C12-15 ALKYL BENZOATE [] LINOLEIC ACID [] CAFFEINE [] CHOLESTEROL [] SQUALANE [] SODIUM PCA [] ACRYLIC ACID/VP CROSSPOLYMER [] UREA [] 1,2-HEXANEDIOL [] CAPRYLIC/CAPRIC TRIGLYCERIDE [] DIPROPYLENE GLYCOL DIBENZOATE [] TOCOPHERYL ACETATE [] TETRAHEXYLDECYL ASCORBATE [] SODIUM HYALURONATE [] PPG-15 STEARYL ETHER BENZOATE [] GLYCYRRHETINIC ACID [] TREHALOSE [] HYDROGENATED LECITHIN [] FUMARIC ACID [] PALMITOYL HYDROXYPROPYLTRIMONIUM AMYLOPECTIN/GLYCERIN CROSSPOLYMER [] CYCLODEXTRIN [] NORDIHYDROGUAIARETIC ACID [] ASCORBYL TOCOPHERYL MALEATE [] CAPRYLYL GLYCOL [] ERGOTHIONEINE [] SODIUM CHLORIDE [] FRAGRANCE (PARFUM) [] SODIUM HYDROXIDE [] CITRIC ACID [] ETHYLBISIMINOMETHYLGUAIACOL MANGANESE CHLORIDE [] DISODIUM EDTA [] PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE [] SODIUM DEHYDROACETATE [] PHENOXYETHANOL

WARNINGS

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

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL:

JO MALONE

VITAMIN E DAY CREAM

NET WT. 1.7 OZ/50ML

DISTR JO MALONE LTD

LONDON, ENGLAND W1K 3BQ

INGREDIENTS AND APPEARANCE

VITAMIN E DAY  SPF 15
octisalate, avobenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62874-005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5.0 mL  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3.0 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
POLYESTER-10 (UNII: 212N9O2MMZ)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
GENTIANA LUTEA ROOT (UNII: S72O3284MS)
BARLEY (UNII: 5PWM7YLI7R)
WHEAT GERM (UNII: YR3G369F5A)
LAMINARIA OCHROLEUCA (UNII: 4R2124HE76)
FUMARIA OFFICINALIS FLOWERING TOP (UNII: VH659J61ZL)
LEMON (UNII: 24RS0A988O)
RICE BRAN (UNII: R60QEP13IC)
ROSEMARY (UNII: IJ67X351P9)
VITIS VINIFERA SEED (UNII: C34U15ICXA)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
DOCOSANOL (UNII: 9G1OE216XY)
GLYCERIN (UNII: PDC6A3C0OX)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
LINOLEIC ACID (UNII: 9KJL21T0QJ)
CAFFEINE (UNII: 3G6A5W338E)
CHOLESTEROL (UNII: 97C5T2UQ7J)
SQUALANE (UNII: GW89575KF9)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
ENOXOLONE (UNII: P540XA09DR)
TREHALOSE (UNII: B8WCK70T7I)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
MASOPROCOL (UNII: 7BO8G1BYQU)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ERGOTHIONEINE (UNII: BDZ3DQM98W)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62874-005-01	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	05/01/2011

Labeler - JO MALONE LTD (347366049)

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