DAYWEAR ADVANCED MULTI-PROTECTION ANTIOXIDANT CREME SPF 15 FOR DRY SKIN- octisalate, avobenzone, homosalate cream 
ESTEE LAUDER INC

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% [] HOMOSALATE 2.00%

INACTIVE INGREDIENTS: WATER\AQUA\EAU [] BUTYLOCTYL SALICYLATE [] POLYESTER-8 [] PETROLATUM [] BUTYLENE GLYCOL [] CETYL RICINOLEATE [] OCTYLDODECYL MYRISTATE [] STEARETH-21 [] STEARETH-2 [] CAPRYLIC/CAPRIC/MYRISTIC/STEARIC TRIGLYCERIDE [] DI-C12-15 ALKYL FUMARATE [] DIMETHICONE [] PSIDIUM GUAJAVA (GUAVA) FRUIT EXTRACT [] GENTIANA LUTEA (GENTIAN) ROOT EXTRACT [] POLYGONUM CUSPIDATUM ROOT EXTRACT [] HORDEUM VULGARE (BARLEY) EXTRACT\EXTRAIT D'ORGE [] LAMINARIA OCHROLEUCA EXTRACT [] TRITICUM VULGARE (WHEAT) GERM EXTRACT [] FUMARIA OFFICINALIS FLOWER/LEAF/STEM EXTRACT [] CITRUS MEDICA LIMONUM (LEMON) FRUIT EXTRACT [] HYDROLYZED RICE BRAN EXTRACT [] HYDROLYZED RICE EXTRACT [] ARTEMIA EXTRACT [] ROSMARINUS OFFICINALIS (ROSEMARY) LEAF EXTRACT [] VITIS VINIFERA (GRAPE) SEED EXTRACT [] STEARYL ALCOHOL [] BUTYROSPERMUM PARKII (SHEA BUTTER) [] THERMUS THERMOPHILLUS FERMENT [] SORBITAN OLIVATE [] CAFFEINE [] PENTYLENE GLYCOL [] LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE [] BEHENYL ALCOHOL [] PANTETHINE [] TRIACONTANYL PVP [] ACRYLIC ACID/VP CROSSPOLYMER [] ETHYLHEXYLGLYCERIN [] GLYCERIN [] LINOLEIC ACID [] POLYQUATERNIUM-51 [] CHOLESTEROL [] CETEARYL OLIVATE [] SQUALANE [] SODIUM PCA [] UREA [] CAPRYLIC/CAPRIC TRIGLYCERIDE [] TOCOPHERYL ACETATE [] TETRAHEXYLDECYL ASCORBATE [] CITRIC ACID [] SODIUM HYALURONATE [] ERGOTHIONEINE [] GLYCYRRHETINIC ACID [] TREHALOSE [] LECITHIN [] HYDROGENATED LECITHIN [] PALMITOYL HYDROXYPROPYLTRIMONIUM AMYLOPECTIN/GLYCERIN CROSSPOLYMER [] CYCLODEXTRIN [] NORDIHYDROGUAIARETIC ACID [] ASCORBYL TOCOPHERYL MALEATE [] SODIUM HYDROXIDE [] FRAGRANCE (PARFUM) [] FUMARIC ACID [] PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE [] ETHYLBISIMINOMETHYLGUAIACOL MANGANESE CHLORIDE [] DISODIUM EDTA [] BHT [] PHENOXYETHANOL [] BENZYL SALICYLATE [] HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE [] BUTYLPHENYL METHYLPROPIONAL [] LINALOOL [] MICA [] YELLOW 5 (CI 19140) [] BLUE 1 (CI 42090) [] CHROMIUM HYDROXIDE GREEN (CI 77289)


WARNING: KEEP OUT OF EYES. DISCONTINUE USE IF IRRITATION OCCURS.

KEEP OUT OF REACH OF CHILDREN.

PRINCIPAL DISPLAY PANEL


ESTEE LAUDER

DAYWEAR

ADVANCED MULTI-PROTECTION ANTI-OXIDANT CREME

SPF 15

FOR DRY SKIN



1.7 FL OZ/50 ML

ESTEE LAUDER DISTR

NY NY 10022

FOLDING CARTON


DAYWEAR  ADVANCED MULTI-PROTECTION ANTIOXIDANT CREME SPF 15 FOR DRY SKIN
octisalate, avobenzone, homosalate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11559-007
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5.0 mL  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3.0 mL  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE2.0 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
PETROLATUM (UNII: 4T6H12BN9U)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
SHEA BUTTER (UNII: K49155WL9Y)  
GLYCERIN (UNII: PDC6A3C0OX)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
SQUALANE (UNII: GW89575KF9)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11559-007-011 in 1 CARTON
1NDC:11559-007-0250 mL in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35209/01/2010
Labeler - ESTEE LAUDER INC (005914387)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD205952385manufacture
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER N.V.370151326manufacture
Establishment
NameAddressID/FEIBusiness Operations
Len-Ron Manufacturing Division of Aramis Inc.809771152manufacture
Establishment
NameAddressID/FEIBusiness Operations
Aramis Inc.042918826manufacture
Establishment
NameAddressID/FEIBusiness Operations
Northtec Bristol949264774manufacture, relabel, repack
Establishment
NameAddressID/FEIBusiness Operations
Northtec Keystone618107429manufacture, relabel, repack
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Pennsylvania Distribution Center 2828534516manufacture, relabel, repack
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Cosmetics, Ltd.255175580manufacture
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Cosmetics, Ltd253616536manufacture
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Cosmetics Distribution Center208579636repack, relabel
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Kabushiki Kaisha712808195relabel, repack
Establishment
NameAddressID/FEIBusiness Operations
Whitman Laboratories Ltd.216866277manufacture
Establishment
NameAddressID/FEIBusiness Operations
Aveda Corporation071352058manufacture

Revised: 12/2010
Document Id: 05b1a435-8ea7-47b9-8c86-aa9d3f749584
Set id: dff89a51-9c4c-4137-9cdf-f4e168ce5645
Version: 1
Effective Time: 20101218
 
ESTEE LAUDER INC