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VITAMIN E DAY SPF 15

Dosage form: cream
Ingredients: OCTISALATE 5.0mL in 100mL, AVOBENZONE 3.0mL in 100mL
Labeler: JO MALONE LTD
NDC Code: 62874-005

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.

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



VITAMIN E DAY  SPF 15
octisalate, avobenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62874-005
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTISALATE (OCTISALATE) OCTISALATE5.0 mL  in 100 mL
AVOBENZONE (AVOBENZONE) AVOBENZONE3.0 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 
Packaging
#Item CodePackage Description
1NDC:62874-005-0150 mL in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35205/01/2011
Labeler - JO MALONE LTD (347366049)
Establishment
NameAddressID/FEIOperations
ESTEE LAUDER COSMETICS, LTD205952385manufacture
Establishment
NameAddressID/FEIOperations
ESTEE LAUDER N.V.370151326manufacture
Establishment
NameAddressID/FEIOperations
Len-Ron Manufacturing Division of Aramis Inc.809771152manufacture
Establishment
NameAddressID/FEIOperations
Aramis Inc.042918826manufacture
Establishment
NameAddressID/FEIOperations
Northtec Bristol949264774manufacture, relabel, repack
Establishment
NameAddressID/FEIOperations
Northtec Keystone618107429manufacture, relabel, repack
Establishment
NameAddressID/FEIOperations
Estee Lauder Pennsylvania Distribution Center 2828534516manufacture, relabel, repack
Establishment
NameAddressID/FEIOperations
Estee Lauder Cosmetics, Ltd.255175580manufacture
Establishment
NameAddressID/FEIOperations
Estee Lauder Cosmetics, Ltd253616536manufacture
Establishment
NameAddressID/FEIOperations
Estee Lauder Cosmetics Distribution Center208579636repack, relabel
Establishment
NameAddressID/FEIOperations
Estee Lauder Kabushiki Kaisha712808195relabel, repack
Establishment
NameAddressID/FEIOperations
Whitman Laboratories Ltd.216866277manufacture
Establishment
NameAddressID/FEIOperations
Aveda Corporation071352058manufacture

Revised: 07/2011
 
JO MALONE LTD

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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