LAB SERIES SKINCARE FOR MEN BB TINTED MOISTURIZER BROAD SPECTRUM SPF 35 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, AND ZINC OXIDE) LIQUID [ARAMIS INC.]

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  • LAB SERIES SKINCARE FOR MEN BB TINTED MOISTURIZER BROAD SPECTRUM SPF 35 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, AND ZINC OXIDE) LIQUID [ARAMIS INC.]

LAB SERIES SKINCARE FOR MEN BB TINTED MOISTURIZER BROAD SPECTRUM SPF 35 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, AND ZINC OXIDE) LIQUID [ARAMIS INC.]
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NDC 42472-002-01
Set ID 23f3dc49-27cb-4c8b-92a1-4b946655e8a3
Category HUMAN OTC DRUG LABEL
Packager Aramis Inc.
Generic Name
Product Class
Product Number
Application Number PART352
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active IngredientsPurpose
    Octinoxate 7.40%Sunscreen
    Octisalate 4.00%Sunscreen
    Oxybenzone 2.50%Sunscreen
    Titanium Dioxide 2.20%Sunscreen
    Zinc Oxide 2.00%Sunscreen
  • Uses

    • Helps prevent sunburn
    • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun
  • Warnings

    For external use only

    Do not use on damaged or broken skin

    When using this product keep out of eyes. Rinse with water to remove.

    Stop use and ask a doctor if rash occurs

    Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Apply liberally 15 minutes before sun exposure
    • Reapply at least every two hours
    • Use a water resistant sunscreen if swimming or sweating
    • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
      • Limit time in the sun, especially from 10 a.m. – 2 p.m.
      • Wear long-sleeved shirts, pants, hats and sunglasses
    • Children under 6 months of age: ask a doctor
  • Inactive Ingredients

    WATER • TRIOCTYLDODECYL CITRATE • METHYL TRIMETHICONE • DIMETHICONE • OCTYLDODECYL STEAROYL STEARATE • BUTYLENE GLYCOL • PHENYL TRIMETHICONE • PENTYLENE GLYCOL • GLYCERYL STEARATE • BEHENYL ALCOHOL • POLYMETHYLSILSESQUIOXANE • PEG-40 STEARATE • POLYGLYCERYL-10 PENTASTEARATE • ACETYL GLUCOSAMINE • TOCOPHERYL ACETATE • SODIUM HYALURONATE • LECITHIN • SQUALANE • SIGESBECKIA ORIENTALIS (ST. PAUL'S WORT) EXTRACT • HORDEUM VULGARE (BARLEY) EXTRACT • TRITICUM VULGARE (WHEAT) GERM EXTRACT • LAMINARIA SACCHARINA EXTRACT • CUCUMIS SATIVUS (CUCUMBER) FRUIT EXTRACT • PYRUS MALUS (APPLE) FRUIT EXTRACT • SCUTELLARIA BAICALENSIS ROOT EXTRACT • CAFFEINE • CHOLESTEROL • GLYCERIN • SODIUM PCA • POLYGLYCERYL-6 POLYRICINOLEATE • ORYZANOL • TREHALOSE • OCTYLDODECYL NEOPENTANOATE • ACETYL HEXAPEPTIDE-8 • PROPYLENE GLYCOL STEARATE • PROPYLENE GLYCOL LAURATE • ISOPROPYL MYRISTATE • ALUMINA • SODIUM STEAROYL LACTYLATE • XANTHAN GUM • SUCROSE • UREA • POLYMETHYL METHACRYLATE • DISODIUM EDTA • AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER • SILICA • ISOPROPYL TITANIUM TRIISOSTEARATE • SORBITAN LAURATE • POLYSORBATE 20 • POLYQUATERNIUM-51 • STEARIC ACID • LINOLEIC ACID • GLYCYRRHETINIC ACID • PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE • PHENOXYETHANOL • CHLORPHENESIN • SODIUM DEHYDROACETATE • [+/- IRON OXIDES (CI 77491, CI 77492, CI 77499) • TITANIUM DIOXIDE (CI 77891)] <ILN37913>

  • Other information

    • Protect the product in this container from excessive heat and direct sun
  • PRINCIPAL DISPLAY PANEL - 50 ml Carton

    LAB
    SERIES
    SKINCARE FOR MEN

    BB TINTED
    MOISTURIZER
    BROAD
    SPECTRUM
    SPF 35

    oil free

    TREAT

    1.7 FL. OZ./OZ. LIQ.
    50 ml e

    Principal Display Panel - 50 ml Carton
  • INGREDIENTS AND APPEARANCE
    LAB SERIES SKINCARE FOR MEN   BB TINTED MOISTURIZER BROAD SPECTRUM SPF 35
    octinoxate, octisalate, oxybenzone, titanium dioxide, and zinc oxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42472-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.4 mL  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4 mL  in 100 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE2.5 mL  in 100 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.2 mL  in 100 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE2 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    TRIOCTYLDODECYL CITRATE (UNII: 35X8CT063R)  
    METHYL TRIMETHICONE (UNII: S73ZQI0GXM)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    OCTYLDODECYL STEAROYL STEARATE (UNII: 3D47Q6D93C)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    PEG-40 STEARATE (UNII: ECU18C66Q7)  
    N-ACETYLGLUCOSAMINE (UNII: V956696549)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    SQUALANE (UNII: GW89575KF9)  
    WHEAT GERM (UNII: YR3G369F5A)  
    SACCHARINA LATISSIMA THALLUS (UNII: 68CMP2MB55)  
    CUCUMBER (UNII: YY7C30VXJT)  
    APPLE (UNII: B423VGH5S9)  
    SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)  
    CAFFEINE (UNII: 3G6A5W338E)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    GAMMA ORYZANOL (UNII: SST9XCL51M)  
    TREHALOSE (UNII: B8WCK70T7I)  
    OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
    ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL)  
    PROPYLENE GLYCOL STEARATE (UNII: MZM1I680W0)  
    PROPYLENE GLYCOL MONOLAURATE (UNII: 668Z5835Z3)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SUCROSE (UNII: C151H8M554)  
    UREA (UNII: 8W8T17847W)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)  
    SORBITAN MONOLAURATE (UNII: 6W9PS8B71J)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    LINOLEIC ACID (UNII: 9KJL21T0QJ)  
    ENOXOLONE (UNII: P540XA09DR)  
    PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42472-002-011 in 1 CARTON
    150 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35204/24/2011
    Labeler - Aramis Inc. (042918826)
    Establishment
    NameAddressID/FEIBusiness Operations
    ELGC K.K.712808195RELABEL(42472-002) , REPACK(42472-002)
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder Pennsylvania Distribution Center 2 (PADC 2)828534516MANUFACTURE(42472-002) , RELABEL(42472-002) , REPACK(42472-002)
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder Inc.042918826MANUFACTURE(42472-002)
    Establishment
    NameAddressID/FEIBusiness Operations
    ESTEE LAUDER COSMETICS DISTRIBUTION CENTER208579636REPACK(42472-002) , RELABEL(42472-002)
    Establishment
    NameAddressID/FEIBusiness Operations
    ESTEE LAUDER COSMETICS, LTD253616536MANUFACTURE(42472-002)
    Establishment
    NameAddressID/FEIBusiness Operations
    ESTEE LAUDER COSMETICS, LTD244669714MANUFACTURE(42472-002)
    Establishment
    NameAddressID/FEIBusiness Operations
    ESTEE LAUDER COSMETICS, LTD.205952385MANUFACTURE(42472-002)
    Establishment
    NameAddressID/FEIBusiness Operations
    ESTEE LAUDER N.V.370151326MANUFACTURE(42472-002)
    Establishment
    NameAddressID/FEIBusiness Operations
    LEN-RON MANUFACTURING DIVISION OF ARAMIS INC809771152MANUFACTURE(42472-002)
    Establishment
    NameAddressID/FEIBusiness Operations
    NORTEC KEYSTONE943871157MANUFACTURE(42472-002) , RELABEL(42472-002) , REPACK(42472-002)
    Establishment
    NameAddressID/FEIBusiness Operations
    NORTHTEC BRISTOL959338336MANUFACTURE(42472-002) , RELABEL(42472-002) , REPACK(42472-002)
    Establishment
    NameAddressID/FEIBusiness Operations
    NORTHTEC KEYSTONE949264774MANUFACTURE(42472-002) , RELABEL(42472-002) , REPACK(42472-002)
    Establishment
    NameAddressID/FEIBusiness Operations
    WHITMAN LABORATORIES, LTD.216866277MANUFACTURE(42472-002)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aveda Corporation071352058MANUFACTURE(42472-002)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pennsylvania Logistics Center078364654REPACK(42472-002) , RELABEL(42472-002)
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