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Name:Vitamin E Dayspf 15
Manufacturer:Jo Malone Ltd
Category:Over-the-counter (OTC) Marketed Drugs


VITAMIN E DAY SPF 15 - octisalate and avobenzone cream 
JO MALONE LTD

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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ACTIVE INGREDIENTS: OCTISALATE 5.00% [] AVOBENZONE 3.00%

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

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

PRINCIPAL DISPLAY PANEL:


JO MALONE

VITAMIN E DAY CREAM



NET WT. 1.7 OZ/50ML



DISTR JO MALONE LTD

LONDON, ENGLAND W1K 3BQ

LABELING




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 DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTISALATE (OCTISALATE) OCTISALATE 5.0 mL  in 100 mL
AVOBENZONE (AVOBENZONE) AVOBENZONE 3.0 mL  in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER  
DIMETHICONE  
BUTYLOCTYL SALICYLATE  
POLYESTER-10  
MEDIUM-CHAIN TRIGLYCERIDES  
GENTIANA LUTEA ROOT  
BARLEY  
WHEAT GERM  
LAMINARIA OCHROLEUCA  
FUMARIA OFFICINALIS FLOWERING TOP  
LEMON  
RICE BRAN  
ROSEMARY  
VITIS VINIFERA SEED  
STEARYL ALCOHOL  
PENTYLENE GLYCOL  
DOCOSANOL  
GLYCERIN  
LECITHIN, SOYBEAN  
ALKYL (C12-15) BENZOATE  
LINOLEIC ACID  
CAFFEINE  
CHOLESTEROL  
SQUALANE  
SODIUM PYRROLIDONE CARBOXYLATE  
1,2-HEXANEDIOL  
.ALPHA.-TOCOPHEROL ACETATE, D-  
TETRAHEXYLDECYL ASCORBATE  
HYALURONATE SODIUM  
ENOXOLONE  
TREHALOSE  
HYDROGENATED SOYBEAN LECITHIN  
MASOPROCOL  
CAPRYLYL GLYCOL  
ERGOTHIONEINE  
SODIUM CHLORIDE  
SODIUM HYDROXIDE  
CITRIC ACID MONOHYDRATE  
EDETATE DISODIUM  
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE)  
SODIUM DEHYDROACETATE  
PHENOXYETHANOL  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62874-005-01 50 mL in 1 JAR None

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 Operations
ESTEE LAUDER COSMETICS, LTD 205952385 manufacture
Establishment
Name Address ID/FEI Operations
ESTEE LAUDER N.V. 370151326 manufacture
Establishment
Name Address ID/FEI Operations
Len-Ron Manufacturing Division of Aramis Inc. 809771152 manufacture
Establishment
Name Address ID/FEI Operations
Aramis Inc. 042918826 manufacture
Establishment
Name Address ID/FEI Operations
Northtec Bristol 949264774 manufacture, relabel, repack
Establishment
Name Address ID/FEI Operations
Northtec Keystone 618107429 manufacture, relabel, repack
Establishment
Name Address ID/FEI Operations
Estee Lauder Pennsylvania Distribution Center 2 828534516 manufacture, relabel, repack
Establishment
Name Address ID/FEI Operations
Estee Lauder Cosmetics, Ltd. 255175580 manufacture
Establishment
Name Address ID/FEI Operations
Estee Lauder Cosmetics, Ltd 253616536 manufacture
Establishment
Name Address ID/FEI Operations
Estee Lauder Cosmetics Distribution Center 208579636 repack, relabel
Establishment
Name Address ID/FEI Operations
Estee Lauder Kabushiki Kaisha 712808195 relabel, repack
Establishment
Name Address ID/FEI Operations
Whitman Laboratories Ltd. 216866277 manufacture
Establishment
Name Address ID/FEI Operations
Aveda Corporation 071352058 manufacture

Revised: 06/2011 JO MALONE LTD



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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