Label: DAYWEAR ADVANCED MULTI-PROTECTION ANTIOXIDANT CREME SPF 15 FOR DRY SKIN- octisalate, avobenzone, homosalate cream
-
Contains inactivated NDC Code(s)
NDC Code(s): 11559-007-01, 11559-007-02 - 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 December 18, 2010
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
-
INACTIVE INGREDIENT
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)
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
DAYWEAR ADVANCED MULTI-PROTECTION ANTIOXIDANT CREME SPF 15 FOR DRY SKIN
octisalate, avobenzone, homosalate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11559-007 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5.0 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) 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:11559-007-01 1 in 1 CARTON 1 NDC:11559-007-02 50 mL in 1 JAR 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
