Label: TENDERTONE LIP BALM SPF 12- octinoxate, octisalate and avobenzone lipstick 

  • Label RSS
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 01/12

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  • ACTIVE INGREDIENTS

    OCTINOXATE 7.50%, OCTISALATE 2.00%, AVOBENZONE 1.50%

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  • WARNING

    STOP USE IF IRRITATION OCCURS.

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  • 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>

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  • SPL UNCLASSIFIED SECTION

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

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  • 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
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  • INGREDIENTS AND APPEARANCE
    TENDERTONE LIP BALM SPF 12 
    octinoxate, octisalate, and avobenzone lipstick
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:40046-0030
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OCTINOXATE (OCTINOXATE) OCTINOXATE 7.5 mL  in 100 mL
    OCTISALATE (OCTISALATE) OCTISALATE 2 mL  in 100 mL
    AVOBENZONE (AVOBENZONE) AVOBENZONE 1.5 mL  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    Petrolatum  
    Astrocaryum Murumuru Seed Butter  
    Arabica Coffee Bean  
    Black Olive  
    Wheat Bran  
    Alpha-Tocopherol Acetate  
    Water  
    Ethylcelluloses  
    Cholesterol  
    Octyldodecanol  
    Caprylyl Glycol  
    Glyceryl Monostearate  
    Linoleic Acid  
    Oleic Acid  
    Palmitic Acid  
    Potassium Sulfate  
    Silicon Dioxide  
    Aluminum Oxide  
    Stannic Oxide  
    Hexylene Glycol  
    Butylated Hydroxytoluene  
    Phenoxyethanol  
    Mica  
    Titanium Dioxide  
    Ferric Oxide Red  
    Ferric Oxide Yellow  
    Ferrosoferric Oxide  
    Bismuth Oxychloride  
    FD&C Blue No. 1  
    Cochineal  
    D&C Red No. 6  
    D&C Red No. 7  
    D&C Red No. 28  
    D&C Red No. 30  
    D&C Red No. 33  
    FD&C Yellow No. 5  
    D&C Yellow No. 10  
    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)
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