Label: ALL YOU NEED CONTINUOUS ACTION 24 HOUR MOISTURE SPF 15 FOR NORMAL SKIN- homosalate, octinoxate, avobenzone lotion

  • 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

    ACTIVE INGREDIENTS: HOMOSALATE 5.00% [] OCTINOXATE 5.00% [] AVOBENZONE 3.00%

  • 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

    WARNING: KEEP OUT OF EYES. STOP USE IF IRRITATION OCCURS. KEEP OUT OF REACH OF CHILDREN.

  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL:

    PX

    PRESCRIPTIVES

    ALL YOU NEED + SPF 15

    CONTINUOUS MOISTURE

    24 HOUR MOISTURE FOR NORMAL SKIN


    1.7 FL OZ/OZ LIQ/50 ML

    PRESCRIPTIVES CO. DISTR
    NEW YORK, NY 10022

    folding carton

  • INGREDIENTS AND APPEARANCE
    ALL YOU NEED  CONTINUOUS ACTION 24 HOUR MOISTURE SPF 15 FOR NORMAL SKIN
    homosalate, octinoxate, avobenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59158-719
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE5.0 mL  in 100 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE5 mL  in 100 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59158-719-011 in 1 CARTON
    150 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35212/01/2007
    Labeler - PRESCRIPTIVES INC. (151701588)
    Establishment
    NameAddressID/FEIBusiness Operations
    ESTEE LAUDER COSMETICS, LTD205952385manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    ESTEE LAUDER N.V.370151326manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Len-Ron Manufacturing Division of Aramis Inc.809771152manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Aramis Inc.042918826manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Northtec Bristol949264774manufacture, relabel, repack
    Establishment
    NameAddressID/FEIBusiness Operations
    Northtec Keystone618107429manufacture, relabel, repack
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder Pennsylvania Distribution Center 2828534516manufacture, relabel, repack
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder Cosmetics, Ltd.255175580manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder Cosmetics, Ltd253616536manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder Cosmetics Distribution Center208579636repack, relabel
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder Kabushiki Kaisha712808195relabel, repack
    Establishment
    NameAddressID/FEIBusiness Operations
    Whitman Laboratories Ltd.216866277manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Aveda Corporation071352058manufacture