Label: ALL YOU NEED CONTINUOUS ACTION 24 HOUR MOISTURE SPF 15 FOR NORMAL SKIN- homosalate, octinoxate, avobenzone lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 59158-719-01 - Packager: PRESCRIPTIVES 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 August 23, 2011
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- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
INACTIVE INGREDIENTS: WATER [] DIMETHICONE [] BUTYLENE GLYCOL [] JOJOBA ESTERS [] VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER [] PEG-12 GLYCERYL DIMYRISTATE [] YEAST EXTRACT\FAEX\EXTRAIT DE LEVURE [] PEG-100 STEARATE [] HYPNEA MUSCIFORMIS (ALGAE) EXTRACT [] GELLIDIELA ACEROSA (ALGAE) EXTRACT [] SALVIA SCLAREA (CLARY) EXTRACT [] LYCIUM CHINENSE (WOLFBERRY) FRUIT EXTRACT [] HORDEUM VULGARE (BARLEY) EXTRACT\EXTRAIT D'ORGE [] VITIS VINIFERA (GRAPE) FRUIT EXTRACT [] CUCUMIS SATIVUS (CUCUMBER) FRUIT EXTRACT [] SCUTELLARIA BAICALENSIS ROOT EXTRACT [] MORUS BOMBYCIS (MULBERRY) ROOT EXTRACT [] ASTROCARYUM MURUMURU SEED BUTTER [] HELIANTHUS ANNUUS (SUNFLOWER) SEEDCAKE [] FISH (PISCES) COLLAGEN [] SUCROSE [] CAFFEINE [] POLYETHYLENE [] LINOLENIC ACID [] GLYCERIN [] LINOLEIC ACID [] SODIUM HYALURONATE [] POLYSORBATE 40 [] PENTAERYTHRITYL TETRAISOSTEARATE [] GLYCERYL STEARATE [] POLYSILICONE-11 [] PROPYLENE GLYCOL DICAPRATE [] ISOHEXADECANE [] OCTOCRYLENE [] ACETYL GLUCOSAMINE [] CETYL ALCOHOL [] STEARETH-21 [] TOCOPHERYL ACETATE [] POLYSORBATE 80 [] ACETYL HEXAPEPTIDE-8 [] CAPRYLYL GLYCOL [] 1,2-HEXANEDIOL [] ACRYLAMIDE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER [] HYDROGENATED LECITHIN [] MALTODEXTRIN [] TREHALOSE [] SODIUM CHONDROITIN SULFATE [] SILICA DIMETHYL SILYLATE [] HEXYLENE GLYCOL [] FRAGRANCE (PARFUM) [] DISODIUM EDTA [] LINALOOL [] CITRONELLOL [] LIMONENE [] SODIUM DEHYDROACETATE [] PHENOXYETHANOL
- WARNINGS
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INGREDIENTS AND APPEARANCE
ALL YOU NEED CONTINUOUS ACTION 24 HOUR MOISTURE SPF 15 FOR NORMAL SKIN
homosalate, octinoxate, avobenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59158-719 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 5.0 mL in 100 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 5 mL in 100 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) SIMMONDSIA CHINENSIS SEED WAX (UNII: 47X6Y9FJJ2) PEG-12 GLYCERYL DIMYRISTATE (UNII: VS4W16AQ3X) YEAST (UNII: 3NY3SM6B8U) PEG-100 STEARATE (UNII: YD01N1999R) HYPNEA MUSCIFORMIS (UNII: W6FF9R1FJV) GELIDIELLA ACEROSA (UNII: T91K54D6M1) CLARY SAGE (UNII: U3HSK5JC0Q) LYCIUM CHINENSIS FRUIT (UNII: TG711Q7A1Q) BARLEY (UNII: 5PWM7YLI7R) WINE GRAPE (UNII: 3GOV20705G) CUCUMBER (UNII: YY7C30VXJT) SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S) MORUS AUSTRALIS ROOT (UNII: 1VL55O45RF) ASTROCARYUM MURUMURU SEED BUTTER (UNII: 12V64UPU6R) HELIANTHUS ANNUUS SEEDCAKE (UNII: 482WYF7XLC) SUCROSE (UNII: C151H8M554) CAFFEINE (UNII: 3G6A5W338E) LINOLENIC ACID (UNII: 0RBV727H71) HYALURONATE SODIUM (UNII: YSE9PPT4TH) POLYSORBATE 40 (UNII: STI11B5A2X) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PROPYLENE GLYCOL DICAPRATE (UNII: U783H9JHWY) ISOHEXADECANE (UNII: 918X1OUF1E) N-ACETYLGLUCOSAMINE (UNII: V956696549) CETYL ALCOHOL (UNII: 936JST6JCN) STEARETH-21 (UNII: 53J3F32P58) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) POLYSORBATE 80 (UNII: 6OZP39ZG8H) ACETYL HEXAPEPTIDE-3 (UNII: L4EL31FWIL) CAPRYLYL GLYCOL (UNII: 00YIU5438U) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N) MALTODEXTRIN (UNII: 7CVR7L4A2D) TREHALOSE (UNII: B8WCK70T7I) HEXYLENE GLYCOL (UNII: KEH0A3F75J) EDETATE DISODIUM (UNII: 7FLD91C86K) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) PHENOXYETHANOL (UNII: HIE492ZZ3T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59158-719-01 1 in 1 CARTON 1 50 mL in 1 BOTTLE, PUMP Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 12/01/2007 Labeler - PRESCRIPTIVES INC. (151701588) 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
