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TENDERTONE LIP BALM SPF 12 (MAKEUP ART COSMETICS)

Available Formats

Dosage Form Package Information Links
LIPSTICK 1 JAR in 1 CARTON (40046-0030-1) > 6 mL in 1 JAR Label Information

Complete TENDERTONE LIP BALM SPF 12 Information

  • ACTIVE INGREDIENTS

    OCTINOXATE 7.50%, OCTISALATE 2.00%, AVOBENZONE 1.50%


  • WARNING

    STOP USE IF IRRITATION OCCURS.


  • INGREDIENTS

    PETROLATUM, HYDROGENATED POLYISOBUTENE, ETHYLENE/PROPYLENE/STYRENE COPOLYMER, ASTROCARYUM MURUMURU SEED BUTTER, COFFEA ARABICA (COFFEE) SEED EXTRACT, OLEA EUROPAEA (OLIVE) FRUIT EXTRACT, TRITICUM VULGARE (WHEAT BRAN) EXTRACT, TOCOPHERYL ACETATE, WATER, HYDROXYETHYLCELLULOSE, ETHYLCELLULOSE, CHOLESTEROL, PENTAERYTHRITYL ADIPATE/CAPRATE/CAPRYLATE/HEPTANOATE, HYDROGENATED DILINOLEYL ALCOHOL, OCTYLDODECANOL, CAPRYLYL GLYCOL, GLYCERYL STEARATE, LINOLEIC ACID, OLEIC ACID, PALMITIC ACID, POTASSIUM SULFATE, SILICA, CALCIUM SODIUM BOROSILICATE, CALCIUM ALUMINUM BOROSILICATE, ALUMINA, TIN OXIDE, HEXYLENE GLYCOL, BUTYLENE/ETHYLENE/STYRENE COPOLYMER, FRAGRANCE, BHT, PHENOXYETHANOL [+/- MICA, TITANIUM DIOXIDE (CI 77891), IRON OXIDES (CI 77491, CI 77492, CI 77499), BISMUTH OXYCHLORIDE (CI 77163), BLUE 1 (CI 42090), BLUE 1 LAKE (CI 42090), CARMINE (CI 75470), RED 6 (CI 15850), RED 7 (CI 15850), RED 7 LAKE (CI 15850), RED 28 LAKE (CI 45410), RED 30 (CI 73360), RED 33 (CI 17200), YELLOW 5 LAKE (CI 19140), YELLOW 10 (CI 47005), YELLOW 10 LAKE (CI 47005)] <ILN33874>


  • SPL UNCLASSIFIED SECTION

    DIST. BY: MAKE-UP ART COSMETICS
    TORONTO, ONTARIO, CANADA M5V 1R7
    LONDON W1K 3BQ / MLWC


  • PRINCIPAL DISPLAY PANEL - 6 ML Jar Carton

    MAC

    TENDERTONE
    LIP BALM SPF 12

    6 ML/0.2 US FL OZ e

    PRINCIPAL DISPLAY PANEL - 6 ML Jar Carton

  • INGREDIENTS AND APPEARANCE
    TENDERTONE LIP BALM SPF 12 
    octinoxate, octisalate, and avobenzone lipstick
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:40046-0030
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 mL  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 2 mL  in 100 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 1.5 mL  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    Petrolatum (UNII: 4T6H12BN9U)  
    Astrocaryum Murumuru Seed Butter (UNII: 12V64UPU6R)  
    Arabica Coffee Bean (UNII: 3SW678MX72)  
    Black Olive (UNII: 2M6QWV94OC)  
    Wheat Bran (UNII: 6L966A1IMR)  
    Alpha-Tocopherol Acetate (UNII: 9E8X80D2L0)  
    Water (UNII: 059QF0KO0R)  
    Ethylcelluloses (UNII: 7Z8S9VYZ4B)  
    Cholesterol (UNII: 97C5T2UQ7J)  
    Octyldodecanol (UNII: 461N1O614Y)  
    Caprylyl Glycol (UNII: 00YIU5438U)  
    Glyceryl Monostearate (UNII: 230OU9XXE4)  
    Linoleic Acid (UNII: 9KJL21T0QJ)  
    Oleic Acid (UNII: 2UMI9U37CP)  
    Palmitic Acid (UNII: 2V16EO95H1)  
    Potassium Sulfate (UNII: 1K573LC5TV)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Aluminum Oxide (UNII: LMI26O6933)  
    Stannic Oxide (UNII: KM7N50LOS6)  
    Hexylene Glycol (UNII: KEH0A3F75J)  
    Butylated Hydroxytoluene (UNII: 1P9D0Z171K)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Mica (UNII: V8A1AW0880)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    Ferric Oxide Red (UNII: 1K09F3G675)  
    Ferric Oxide Yellow (UNII: EX438O2MRT)  
    Ferrosoferric Oxide (UNII: XM0M87F357)  
    Bismuth Oxychloride (UNII: 4ZR792I587)  
    FD&C Blue No. 1 (UNII: H3R47K3TBD)  
    Cochineal (UNII: TZ8Z31B35M)  
    D&C Red No. 6 (UNII: 481744AI4O)  
    D&C Red No. 7 (UNII: ECW0LZ41X8)  
    D&C Red No. 28 (UNII: 767IP0Y5NH)  
    D&C Red No. 30 (UNII: 2S42T2808B)  
    D&C Red No. 33 (UNII: 9DBA0SBB0L)  
    FD&C Yellow No. 5 (UNII: I753WB2F1M)  
    D&C Yellow No. 10 (UNII: 35SW5USQ3G)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:40046-0030-1 1 in 1 CARTON
    1 6 mL in 1 JAR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part352 01/01/2007
    Labeler - MAKEUP ART COSMETICS (010597206)
    Establishment
    Name Address ID/FEI Business Operations
    ELGC Kabushiki Kaisha 712808195 RELABEL(40046-0030) , REPACK(40046-0030)
    Establishment
    Name Address ID/FEI Business Operations
    Estee Lauder Pennsylvania Distribution Center 2 (PADC 2) 828534516 MANUFACTURE(40046-0030) , RELABEL(40046-0030) , REPACK(40046-0030)
    Establishment
    Name Address ID/FEI Business Operations
    ARAMIS, INC 042918826 MANUFACTURE(40046-0030)
    Establishment
    Name Address ID/FEI Business Operations
    ESTEE LAUDER COSMETICS DISTRIBUTION CENTER 208579636 RELABEL(40046-0030) , REPACK(40046-0030)
    Establishment
    Name Address ID/FEI Business Operations
    ESTEE LAUDER COSMETICS, LTD 253616536 MANUFACTURE(40046-0030)
    Establishment
    Name Address ID/FEI Business Operations
    ESTEE LAUDER COSMETICS, LTD 255175580 MANUFACTURE(40046-0030)
    Establishment
    Name Address ID/FEI Business Operations
    ESTEE LAUDER COSMETICS, LTD. 205952385 MANUFACTURE(40046-0030)
    Establishment
    Name Address ID/FEI Business Operations
    ESTEE LAUDER N.V. 370151326 MANUFACTURE(40046-0030)
    Establishment
    Name Address ID/FEI Business Operations
    LEN-RON MANUFACTURING DIVISION OF ARAMIS INC 809771152 MANUFACTURE(40046-0030)
    Establishment
    Name Address ID/FEI Business Operations
    NORTEC KEYSTONE 787336577 MANUFACTURE(40046-0030) , RELABEL(40046-0030) , REPACK(40046-0030)
    Establishment
    Name Address ID/FEI Business Operations
    NORTHTEC BRISTOL 949264774 MANUFACTURE(40046-0030) , RELABEL(40046-0030) , REPACK(40046-0030)
    Establishment
    Name Address ID/FEI Business Operations
    NORTHTEC KEYSTONE 618107429 MANUFACTURE(40046-0030) , RELABEL(40046-0030) , REPACK(40046-0030)
    Establishment
    Name Address ID/FEI Business Operations
    WHITMAN LABORATORIES, LTD. 216866277 MANUFACTURE(40046-0030)
    Establishment
    Name Address ID/FEI Business Operations
    Aveda Corporation 071352058 MANUFACTURE(40046-0030)