Label: TIME ZONE LINE AND WRINKLE REDUCING CREME SPF 15 FOR DRY SKIN- octsalate, avobenzone cream
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Contains inactivated NDC Code(s)
NDC Code(s): 11559-728-01, 11559-728-02 - Packager: ESTEE LAUDER INC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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 July 22, 2011
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- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
INGREDIENTS: WATER\AQUA\EAU [] DIMETHICONE [] BUTYROSPERMUM PARKII (SHEA BUTTER) [] POLYESTER-8 [] BUTYLENE GLYCOL [] DI-C12-15 ALKYL FUMARATE [] STEARETH-21 [] PENTAERYTHRITYL TETRAETHYLHEXANOATE [] SUCROSE [] CETYL ALCOHOL [] NEOPENTYL GLYCOL DIETHYLHEXANOATE [] HDI/PPG/POLYCAPROLACTONE CROSSPOLYMER [] GLYCERIN [] STEARETH-2 [] ACRYLAMIDE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER [] CUCUMIS SATIVUS (CUCUMBER) FRUIT EXTRACT [] ROSMARINUS OFFICINALIS (ROSEMARY) EXTRACT [] SELAGINELLA TAMARISCINA (SPIKE MOSS) EXTRACT [] CITRUS RETICULATA (TANGERINE) PEEL EXTRACT [] HUMULUS LUPULUS (HOPS) EXTRACT [] YEAST EXTRACT\FAEX\EXTRAIT DE LEVURE [] TRITICUM VULGARE (WHEAT BRAN) EXTRACT [] HORDEUM VULGARE (BARLEY) EXTRACT\EXTRAIT D'ORGE [] TAMARINDUS INDICA SEED EXTRACT [] ARGANIA SPINOSA LEAF EXTRACT [] HYDROLYZED RICE EXTRACT [] PADINA PAVONICA THALLUS EXTRACT [] LARIX SIBIRICA WOOD EXTRACT [] POLYGONUM CUSPIDATUM ROOT EXTRACT [] VITIS VINIFERA (GRAPE) SEED EXTRACT [] SIGESBECKIA ORIENTALIS (ST. PAUL'S WORT) EXTRACT [] PUNICA GRANATUM (POMEGRANATE) JUICE EXTRACT [] OLEA EUROPAEA (OLIVE) FRUIT EXTRACT [] CENTAURIUM ERYTHRAEA (CENTAURY) EXTRACT [] LAMINARIA SACCHARINA EXTRACT [] CHOLESTEROL [] CREATINE [] ADENOSINE PHOSPHATE [] HELIANTHUS ANNUUS (SUNFLOWER) SEEDCAKE [] CAFFEINE [] POLYETHYLENE [] PVP/HEXADECENE COPOLYMER [] CETYL DIMETHICONE [] ISOHEXADECANE [] DIPENTAERYTHRITYL TRI-POLYHYDROXYSTEARATE [] PPG-15 STEARYL ETHER [] POLYSILICONE-11 [] TOCOPHERYL ACETATE [] LINOLENIC ACID [] PHYTANTRIOL [] SODIUM HYALURONATE [] TREHALOSE [] ACETYL GLUCOSAMINE [] HYALURONIC ACID [] ETHYLHEXYLGLYCERIN [] ACETYL HEXAPEPTIDE-8 [] CAPRYLYL GLYCOL [] PROPYLENE GLYCOL DICAPRATE [] SODIUM PCA [] PROPYLENE GLYCOL HEPTANOATE [] POLYSORBATE 80 [] CYCLODEXTRIN [] LINOLEIC ACID [] ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER [] NEOPENTYL GLYCOL DIISOSTEARATE [] TROMETHAMINE [] HEXYLENE GLYCOL [] SILICA [] FRAGRANCE (PARFUM) [] NORDIHYDROGUAIARETIC ACID [] ETHYLBISIMINOMETHYLGUAIACOL MANGANESE CHLORIDE [] DISODIUM EDTA [] PHENOXYETHANOL [] POLYAMINOPROPYL BIGUANIDE [] MICA
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
TIME ZONE LINE AND WRINKLE REDUCING CREME SPF 15 FOR DRY SKIN
octsalate, avobenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11559-728 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 Inactive Ingredients Ingredient Name Strength BUTYLENE GLYCOL (UNII: 3XUS85K0RA) GLYCERIN (UNII: PDC6A3C0OX) DIMETHICONE (UNII: 92RU3N3Y1O) CETYL ALCOHOL (UNII: 936JST6JCN) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) SACCHAROMYCES LYSATE (UNII: R85W246Z1C) CUCUMBER (UNII: YY7C30VXJT) OLIVE OIL (UNII: 6UYK2W1W1E) BARLEY (UNII: 5PWM7YLI7R) TAMARIND SEED (UNII: 6AHP8A7OML) SACCHARINA LATISSIMA WHOLE (UNII: RTR3OGP8ET) CHOLESTEROL (UNII: 97C5T2UQ7J) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) LINOLEIC ACID (UNII: 9KJL21T0QJ) TREHALOSE (UNII: B8WCK70T7I) CREATINE (UNII: MU72812GK0) CAPRYLYL GLYCOL (UNII: 00YIU5438U) POLYSORBATE 60 (UNII: CAL22UVI4M) HYALURONATE SODIUM (UNII: YSE9PPT4TH) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E) EDETATE DISODIUM (UNII: 7FLD91C86K) PHENOXYETHANOL (UNII: HIE492ZZ3T) MICA (UNII: V8A1AW0880) POLYAMINOPROPYL BIGUANIDE (UNII: 322U039GMF) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11559-728-01 1 in 1 CARTON 1 NDC:11559-728-02 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 11/01/2009 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
