MARK TOTALLY BALMED (OCTINOXATE, OXYBENZONE, OCTISALATE, AVOBENZONE ) LIPSTICK [AVON PRODUCTS, INC.]

MARK TOTALLY BALMED (OCTINOXATE, OXYBENZONE, OCTISALATE, AVOBENZONE ) LIPSTICK [AVON PRODUCTS, INC.]
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NDC 10096-0201-1, 10096-0201-2
Set ID adf84113-e046-481c-865a-c397c4694e2d
Category HUMAN OTC DRUG LABEL
Packager Avon Products, Inc.
Generic Name
Product Class
Product Number
Application Number PART352
  • INDICATIONS & USAGE

    Uses: Helps prevent sunburn. Higher SPF gives more sunburn protection.
  • DOSAGE & ADMINISTRATION

    Directions: Glide on lips. Apply liberally before sun
    exposure and as needed.

  • WARNINGS

    Warning: Discontinue use if skin irritation develops or increases. If irritation persists, consult a doctor.

  • ACTIVE INGREDIENT

    Active Ingredients:
         OCTINOXATE 7.00%
         OXYBENZONE 4.75%
         OCTISALATE 4.75%
         AVOBENZONE 2.00%

  • INACTIVE INGREDIENT

         RICINUS COMMUNIS (CASTOR) SEED OIL
         BEESWAX/CIRE D'ABEILLE
         HYDROGENATED VEGETABLE OIL
         EUPHORBIA CERIFERA (CANDELILLA) WAX/CIRE DE CANDELILLA
         PETROLATUM
         C10-30 CHOLESTEROL/LANOSTEROL ESTERS
         HYDROGENATED CASTOR OIL
         AROMA/FLAVOR
         ALOE BARBADENSIS LEAF EXTRACT
         SESAMUM INDICUM (SESAME) SEED OIL
         BENZOIC ACID  
         ASCORBYL PALMITATE
         TOCOPHERYL ACETATE
         RETINYL PALMITATE
         SACCHARIN
         TOCOPHEROL
         TIN OXIDE

    MAY CONTAIN:
           MICA/CI 77019
           TITANIUM DIOXIDE/CI 77891
           IRON OXIDES
           RED 7 LAKE
           YELLOW 5 LAKE/CI 19140
           RED 33 LAKE/CI 17200
           RED 6/CI 15850
           BLUE 1 LAKE/CI 42090
           BISMUTH OXYCHLORIDE/CI 77163
           ORANGE 5/CI 45370
           RED 21 LAKE/CI 45380
           RED 21/CI 45380
           RED 22 LAKE/CI 45380
           RED 27 LAKE/CI 45410
           RED 28 LAKE/CI 45410
           RED 30 LAKE/CI 73360
           YELLOW 10 LAKE/CI 47005
           YELLOW 6 LAKE/CI 15985
           RED 40 LAKE/CI 16035

  • PRINCIPAL DISPLAY PANEL

    image of cartonimage of carton

  • INGREDIENTS AND APPEARANCE
    MARK  TOTALLY BALMED
    octinoxate, oxybenzone, octisalate, avobenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10096-0201
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE294 mg  in 4.2 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE199.5 mg  in 4.2 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE199.5 mg  in 4.2 g
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 84 mg  in 4.2 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    SACCHARIN (UNII: FST467XS7D)  
    MICA (UNII: V8A1AW0880)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10096-0201-21 in 1 CARTON
    1NDC:10096-0201-14.2 g in 1 CASE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35206/02/2010
    Labeler - Avon Products, Inc. (001468693)
    Establishment
    NameAddressID/FEIBusiness Operations
    Avon Products, Inc.001807106manufacture

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