SUNTINTS LIQUID LIP BALM SPF 20 (OCTINOXATE, OCTISALATE, AVOBENZONE, HOMOSALATE, OCTOCRYLENE) LIPSTICK [MAKEUP ART COSMETICS]

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  • SUNTINTS LIQUID LIP BALM SPF 20 (OCTINOXATE, OCTISALATE, AVOBENZONE, HOMOSALATE, OCTOCRYLENE) LIPSTICK [MAKEUP ART COSMETICS]

SUNTINTS LIQUID LIP BALM SPF 20 (OCTINOXATE, OCTISALATE, AVOBENZONE, HOMOSALATE, OCTOCRYLENE) LIPSTICK [MAKEUP ART COSMETICS]
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NDC 40046-0034-1, 40046-0034-2
Set ID d203780c-e770-435a-acff-0162e1483605
Category HUMAN OTC DRUG LABEL
Packager MAKEUP ART COSMETICS
Generic Name
Product Class
Product Number
Application Number PART352
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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS: OCTINOXATE 7.50% [] OCTISALATE 5.00% [] AVOBENZONE 3.00% [] HOMOSALATE 2.90% [] OCTOCRYLENE 2.70%

  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS: OCTYLDODECANOL [] NEOPENTYL GLYCOL DIHEPTANOATE [] ETHYLCELLULOSE [] DIISOSTEARYL MALATE [] BUTYLOCTYL SALICYLATE [] DICAPRYLYL CARBONATE [] TOCOPHERYL ACETATE [] POLYGONUM CUSPIDATUM ROOT EXTRACT [] DEXTRIN PALMITATE [] CALCIUM ALUMINUM BOROSILICATE [] CALCIUM SODIUM BOROSILICATE [] CAPRYLYL GLYCOL [] HEXYLENE GLYCOL [] SILICA [] TIN OXIDE [] LINOLEIC ACID [] HYDROGENATED DILINOLEYL ALCOHOL [] VANILLIN [] PHENOXYETHANOL []  [+/- MICA [] IRON OXIDES (CI 77491, CI 77492, CI 77499) [] TITANIUM DIOXIDE (CI 77891) [] BISMUTH OXYCHLORIDE (CI 77163) [] BLUE 1 LAKE (CI 42090) [] CARMINE (CI 75470) [] RED 6 (CI 15850) [] RED 7 LAKE (CI 15850) [] RED 28 LAKE (CI 45410) [] RED 30 LAKE (CI 73360) [] RED 33 LAKE (CI 17200) [] YELLOW 5 LAKE (CI 19140) [] YELLOW 6 LAKE (CI 15985)]

  • WARNINGS

    WARNING: STOP USE IF IRRITATION OCCURS.

  • PRINCIPAL DISPLAY PANEL

    MAC

    SUNTINTS SPF 20

    LIQUID BALM




    10 ML/ .33 FL OZ LIQ





    MAKE UP ART COSMETICS, DIST

    NY,NY 10022

    FOLDING CARTON

  • INGREDIENTS AND APPEARANCE
    SUNTINTS  LIQUID LIP BALM SPF 20
    octinoxate, octisalate, avobenzone, homosalate, octocrylene lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:40046-0034
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 mL  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5.0 mL  in 100 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3.0 mL  in 100 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE2.9 mL  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE2.7 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
    ETHYLCELLULOSES (UNII: 7Z8S9VYZ4B)  
    DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    POLYGONUM CUSPIDATUM ROOT (UNII: 7TRV45YZF7)  
    CALCIUM ALUMINOSILICATE (UNII: 3L00JH8411)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STANNIC OXIDE (UNII: KM7N50LOS6)  
    LINOLEIC ACID (UNII: 9KJL21T0QJ)  
    VANILLIN (UNII: CHI530446X)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    MICA (UNII: V8A1AW0880)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:40046-0034-11 in 1 CARTON
    1NDC:40046-0034-210 mL in 1 VIAL
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35212/01/2009
    Labeler - MAKEUP ART COSMETICS (010597206)
    Establishment
    NameAddressID/FEIBusiness Operations
    Len-Ron Manufacturing Division of Aramis Inc.809771152manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder Inc042918826manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Northtec Keystone949264774manufacture, relabel, repack
    Establishment
    NameAddressID/FEIBusiness Operations
    Northtec Bristol959338336manufacture, relabel, repack
    Establishment
    NameAddressID/FEIBusiness Operations
    Northtec Keystone943871157manufacture, relabel, repack
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder Pennsylvania Distribution Center 2828534516manufacture, relabel, repack
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder Cosmetics Ltd.205952385manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder Cosmetics, Ltd.244669714manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder Cosmetics, Ltd.253616536manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder Cosmetics Distribution Centre208579636repack, relabel
    Establishment
    NameAddressID/FEIBusiness Operations
    ELGC K.K.712808195relabel, repack
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder N.V.370151326manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Whitman Laboratories Ltd.216866277manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Aveda Corporation071352058manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Pennsylvania Logistics Center (PALC)078364654repack, relabel
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