Label: DAYWEAR ADVANCED MULTI-PROTECTION ANTIOXIDANT SPF 15 OILY SKIN- octisalate, avobenzone, homosalate lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 11559-010-01, 11559-010-02 - Packager: ESTEE LAUDER INC
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated January 19, 2011
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- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
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)
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DAYWEAR ADVANCED MULTI-PROTECTION ANTIOXIDANT SPF 15 OILY SKIN
octisalate, avobenzone, homosalate lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11559-010 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 4.9 mL in 100 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3.0 mL in 100 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 2.0 mL in 100 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:11559-010-01 1 in 1 CARTON 1 NDC:11559-010-02 50 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 09/01/2010 Labeler - ESTEE LAUDER INC (005914387) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD 205952385 manufacture Establishment Name Address ID/FEI Business Operations ESTEE LAUDER N.V. 370151326 manufacture Establishment Name Address ID/FEI Business Operations Len-Ron Manufacturing Division of Aramis Inc. 809771152 manufacture Establishment Name Address ID/FEI Business Operations Aramis Inc. 042918826 manufacture Establishment Name Address ID/FEI Business Operations Northtec Bristol 949264774 manufacture, relabel, repack Establishment Name Address ID/FEI Business Operations Northtec Keystone 618107429 manufacture, relabel, repack Establishment Name Address ID/FEI Business Operations Estee Lauder Pennsylvania Distribution Center 2 828534516 manufacture, relabel, repack Establishment Name Address ID/FEI Business Operations Estee Lauder Cosmetics, Ltd. 255175580 manufacture Establishment Name Address ID/FEI Business Operations Estee Lauder Cosmetics, Ltd 253616536 manufacture Establishment Name Address ID/FEI Business Operations Estee Lauder Cosmetics Distribution Center 208579636 repack, relabel Establishment Name Address ID/FEI Business Operations Estee Lauder Kabushiki Kaisha 712808195 relabel, repack Establishment Name Address ID/FEI Business Operations Whitman Laboratories Ltd. 216866277 manufacture Establishment Name Address ID/FEI Business Operations Aveda Corporation 071352058 manufacture
