DAYWEAR ADVANCED MULTI-PROTECTION ANTIOXIDANT SPF 15 OILY SKIN- octisalate, avobenzone, homosalate lotion 
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 4.90% [] AVOBENZONE 3.00% [] HOMOSALATE 2.00%

INACTIVE INGREDIENTS: INGREDIENTS: WATER\AQUA\EAU [] DIMETHICONE [] METHYL TRIMETHICONE [] BUTYLOCTYL SALICYLATE [] POLYESTER-8 [] PENTYLENE GLYCOL [] BUTYLENE GLYCOL [] ACRYLATES COPOLYMER [] HYDROGENATED LECITHIN [] OCTYLDODECYL NEOPENTANOATE [] C12-15 ALKYL BENZOATE [] PSIDIUM GUAJAVA (GUAVA) FRUIT EXTRACT [] ROSMARINUS OFFICINALIS (ROSEMARY) LEAF EXTRACT [] VITIS VINIFERA (GRAPE) SEED EXTRACT [] GENTIANA LUTEA (GENTIAN) ROOT EXTRACT [] POLYGONUM CUSPIDATUM ROOT EXTRACT [] HORDEUM VULGARE (BARLEY) EXTRACT\EXTRAIT D'ORGE [] TRITICUM VULGARE (WHEAT) GERM EXTRACT [] FUMARIA OFFICINALIS FLOWER/LEAF/STEM EXTRACT [] CITRUS MEDICA LIMONUM (LEMON) FRUIT EXTRACT [] THERMUS THERMOPHILLUS FERMENT [] HYDROLYZED RICE BRAN EXTRACT [] LAMINARIA SACCHARINA EXTRACT [] HYDROLYZED RICE EXTRACT [] ARTEMIA EXTRACT [] NEOPENTYL GLYCOL DIHEPTANOATE [] TRIMETHYLSILOXYSILICATE [] PVP/HEXADECENE COPOLYMER [] VP/EICOSENE COPOLYMER [] GLYCERIN [] ISOHEXADECANE [] DIPROPYLENE GLYCOL DIBENZOATE [] CHOLETH-24 [] CETETH-24 [] LINOLEIC ACID [] CHOLESTEROL [] CAFFEINE [] PHOSPHOLIPIDS [] POLYSORBATE 80 [] SQUALANE [] SODIUM PCA [] UREA [] ERGOTHIONEINE [] PPG-15 STEARYL ETHER BENZOATE [] TETRAHEXYLDECYL ASCORBATE [] SUCROSE [] SODIUM HYALURONATE [] GLYCYRRHETINIC ACID [] TREHALOSE [] POLYQUATERNIUM-51 [] LECITHIN [] HYDROGENATED POLYISOBUTENE [] POLYETHYLENE [] PALMITOYL HYDROXYPROPYLTRIMONIUM AMYLOPECTIN/GLYCERIN CROSSPOLYMER [] CYCLODEXTRIN [] NORDIHYDROGUAIARETIC ACID [] FRAGRANCE (PARFUM) [] ASCORBYL TOCOPHERYL MALEATE [] FUMARIC ACID [] ACRYLAMIDE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER [] CITRIC ACID [] SODIUM HYDROXIDE [] TOCOPHERYL ACETATE [] PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE [] ETHYLBISIMINOMETHYLGUAIACOL MANGANESE CHLORIDE [] DISODIUM EDTA [] BHT [] PHENOXYETHANOL [] BUTYLPHENYL METHYLPROPIONAL [] HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE [] BENZYL SALICYLATE [] LINALOOL [] YELLOW 5 (CI 19140) [] BLUE 1 (CI 42090)


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 LOTION

SPF 15

FOR OILY SKIN


1.7 FL LIQ OZ/ 50 ML

ESTEE LAUDER DISTR

NY NY 10022
FOLDING CARTON

DAYWEAR  ADVANCED MULTI-PROTECTION ANTIOXIDANT SPF 15 OILY SKIN
octisalate, avobenzone, homosalate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11559-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4.9 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)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
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)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11559-010-011 in 1 CARTON
1NDC:11559-010-0250 mL in 1 TUBE
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: 1/2011
Document Id: fd8e22f2-cb7e-4462-8957-ab48e76403d3
Set id: a2e569fa-d0d7-4873-be21-c3831a97aad3
Version: 2
Effective Time: 20110119
 
ESTEE LAUDER INC