DAYWEAR SHEER TINT RELEASE ADVANCED MULTI-PROTECTION ANTI-OXIDANT MOISTURIZER SPF 15

Dosage form: lotion
Ingredients: OCTISALATE 5.0mL in 100mL, AVOBENZONE 3.0mL in 100mL
Labeler: ESTEE LAUDER INC
NDC Code: 11559-008

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%

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 [] STEARYL ALCOHOL [] PSIDIUM GUAJAVA (GUAVA) FRUIT EXTRACT [] GENTIANA LUTEA (GENTIAN) ROOT EXTRACT [] POLYGONUM CUSPIDATUM ROOT EXTRACT [] HORDEUM VULGARE (BARLEY) EXTRACT\EXTRAIT D'ORGE [] TRITICUM VULGARE (WHEAT) GERM EXTRACT [] CITRUS MEDICA LIMONUM (LEMON) FRUIT EXTRACT [] LAMINARIA OCHROLEUCA EXTRACT [] HYDROLYZED RICE BRAN EXTRACT [] HYDROLYZED RICE EXTRACT [] FUMARIA OFFICINALIS FLOWER/LEAF/STEM EXTRACT [] ROSMARINUS OFFICINALIS (ROSEMARY) LEAF EXTRACT [] ARTEMIA EXTRACT [] VITIS VINIFERA (GRAPE) SEED EXTRACT [] THERMUS THERMOPHILLUS FERMENT [] CHOLESTEROL [] POLYQUATERNIUM-51 [] HYDROGENATED LECITHIN [] ERGOTHIONEINE [] CAFFEINE [] LINOLEIC ACID [] PENTYLENE GLYCOL [] ISOPROPYL MYRISTATE [] LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE [] BEHENYL ALCOHOL [] TRIACONTANYL PVP [] GLYCERIN [] ACRYLIC ACID/VP CROSSPOLYMER [] POLYMETHYL METHACRYLATE [] C12-15 ALKYL BENZOATE [] SQUALANE [] SODIUM PCA [] 1,2-HEXANEDIOL [] UREA [] CAPRYLIC/CAPRIC TRIGLYCERIDE [] PALMITOYL HYDROXYPROPYLTRIMONIUM AMYLOPECTIN/GLYCERIN CROSSPOLYMER [] DIPROPYLENE GLYCOL DIBENZOATE [] TOCOPHERYL ACETATE [] TETRAHEXYLDECYL ASCORBATE [] CITRIC ACID [] SODIUM HYALURONATE [] PPG-15 STEARYL ETHER BENZOATE [] GLYCYRRHETINIC ACID [] CAPRYLYL GLYCOL [] TREHALOSE [] LECITHIN [] SODIUM HYDROXIDE [] FUMARIC ACID [] CYCLODEXTRIN [] NORDIHYDROGUAIARETIC ACID [] ASCORBYL TOCOPHERYL MALEATE [] ETHYLBISIMINOMETHYLGUAIACOL MANGANESE CHLORIDE [] FRAGRANCE (PARFUM) [] DISODIUM EDTA [] BHT [] SODIUM DEHYDROACETATE [] PHENOXYETHANOL [] IRON OXIDES (CI 77491, CI 77492, CI 77499) [] TITANIUM DIOXIDE (CI 77891)


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

KEEP OUT OF REACH OF CHILDREN.

PRINCIPAL DISPLAY PANEL:



ESTEE LAUDER
DAYWEAR

SHEER TINT RELEASE
ADVANCED MULTI-PROTECTION
ANTI-OXIDANT MOISTURIZER
SPF 15


1.7 FL OZ. LIQ/ 50ML

ESTEE LAUDER DISTR

NEW YORK, NY 10022

DAYWEAR  SHEER TINT RELEASE ADVANCED MULTI-PROTECTION ANTI-OXIDANT MOISTURIZER SPF 15
octisalate, avobenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11559-008
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 Description
1NDC:11559-008-011 TUBE (TUBE) in 1 TUBE
1NDC:11559-008-0250 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/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: 12/2010
 
ESTEE LAUDER INC

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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