Your browser does not support JavaScript! DAYWEAR ADVANCED MULTIPROTECTION ANTIOXIDANT CREME SPF 15 FOR NORMAL COMBINATION SKIN (OCTISALATE, AVOBENZONE) CREAM [ESTEE LAUDER INC]
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DAYWEAR ADVANCED MULTIPROTECTION ANTIOXIDANT CREME SPF 15 FOR NORMAL COMBINATION SKIN (octisalate, avobenzone) cream
[ESTEE LAUDER INC]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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.
Drug Label Sections

ACTIVE INGREDIENTS: OCTISALATE 5.00% [] AVOBENZONE 3.00%

INACTIVE INGREDIENTS: WATER\AQUA\EAU [] 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 [] PSIDIUM GUAJAVA (GUAVA) FRUIT EXTRACT [] GENTIANA LUTEA (GENTIAN) ROOT EXTRACT [] POLYGONUM CUSPIDATUM ROOT EXTRACT [] STEARYL ALCOHOL [] HORDEUM VULGARE (BARLEY) EXTRACT\EXTRAIT D'ORGE [] LAMINARIA OCHROLEUCA EXTRACT [] ROSMARINUS OFFICINALIS (ROSEMARY) LEAF EXTRACT [] TRITICUM VULGARE (WHEAT) GERM EXTRACT [] ARTEMIA EXTRACT [] FUMARIA OFFICINALIS FLOWER/LEAF/STEM EXTRACT [] CAFFEINE [] PENTYLENE GLYCOL [] CITRUS MEDICA LIMONUM (LEMON) FRUIT EXTRACT [] HYDROLYZED RICE EXTRACT [] VITIS VINIFERA (GRAPE) SEED EXTRACT [] HYDROLYZED RICE BRAN EXTRACT [] LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE [] THERMUS THERMOPHILLUS FERMENT [] BEHENYL ALCOHOL [] ACRYLIC ACID/VP CROSSPOLYMER [] TRIACONTANYL PVP [] GLYCERIN [] C12-15 ALKYL BENZOATE [] LINOLEIC ACID [] CHOLESTEROL [] SQUALANE [] SODIUM PCA [] 1,2-HEXANEDIOL [] UREA [] CAPRYLIC/CAPRIC TRIGLYCERIDE [] DIPROPYLENE GLYCOL DIBENZOATE [] TOCOPHERYL ACETATE [] TETRAHEXYLDECYL ASCORBATE [] SODIUM HYALURONATE [] ERGOTHIONEINE [] PPG-15 STEARYL ETHER BENZOATE [] GLYCYRRHETINIC ACID [] TREHALOSE [] POLYQUATERNIUM-51 [] LECITHIN [] HYDROGENATED LECITHIN [] FUMARIC ACID [] PALMITOYL HYDROXYPROPYLTRIMONIUM AMYLOPECTIN/GLYCERIN CROSSPOLYMER [] CAPRYLYL GLYCOL [] CYCLODEXTRIN [] SODIUM HYDROXIDE [] NORDIHYDROGUAIARETIC ACID [] SODIUM CHLORIDE [] ASCORBYL TOCOPHERYL MALEATE [] FRAGRANCE (PARFUM) [] CITRIC ACID [] ETHYLBISIMINOMETHYLGUAIACOL MANGANESE CHLORIDE [] PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE [] DISODIUM EDTA [] SODIUM DEHYDROACETATE [] PHENOXYETHANOL [] BUTYLPHENYL METHYLPROPIONAL [] HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE [] BENZYL SALICYLATE [] LINALOOL [] BLUE 1 (CI 42090) [] YELLOW 5 (CI 19140) [] 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
ANTIOXIDANT CREME
SPF 15
FOR NORMAL COMBINATION SKIN



1.7  OZ /50 ML

ESTEE LAUDER DISTR
NEW YORK, NY 10022



FOLDING CARTON



DAYWEAR  ADVANCED MULTIPROTECTION ANTIOXIDANT CREME SPF 15 FOR NORMAL COMBINATION SKIN
octisalate, avobenzone cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:11559-009
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 
BUTYLENE GLYCOL 
DIMETHICONE 
GLYCERIN 
CHOLESTEROL 
SQUALANE 
CITRIC ACID MONOHYDRATE 
LECITHIN, SOYBEAN 
BUTYLATED HYDROXYTOLUENE 
PHENOXYETHANOL 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11559-009-011 in 1 CARTON
1NDC:11559-009-0250 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: 4/2011
 
ESTEE LAUDER INC

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