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LAB SERIES SKINCARE FOR MEN (Aramis Inc.)

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LIQUID 1 BOTTLE in 1 CARTON (42472-002-01) > 50 mL in 1 BOTTLE Label Information

Complete LAB SERIES SKINCARE FOR MEN Information

  • SPL UNCLASSIFIED SECTION

    Drug Facts


  • ACTIVE INGREDIENT

    Active Ingredients Purpose
    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 Type HUMAN OTC DRUG Item Code (Source) NDC:42472-002
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.4 mL  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 4 mL  in 100 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 2.5 mL  in 100 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2.2 mL  in 100 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 2 mL  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    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 Code Package Description Marketing Start Date Marketing End Date
    1 NDC:42472-002-01 1 in 1 CARTON
    1 50 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part352 04/24/2011
    Labeler - Aramis Inc. (042918826)
    Establishment
    Name Address ID/FEI Business Operations
    ELGC K.K. 712808195 RELABEL(42472-002) , REPACK(42472-002)
    Establishment
    Name Address ID/FEI Business Operations
    Estee Lauder Pennsylvania Distribution Center 2 (PADC 2) 828534516 MANUFACTURE(42472-002) , RELABEL(42472-002) , REPACK(42472-002)
    Establishment
    Name Address ID/FEI Business Operations
    Estee Lauder Inc. 042918826 MANUFACTURE(42472-002)
    Establishment
    Name Address ID/FEI Business Operations
    ESTEE LAUDER COSMETICS DISTRIBUTION CENTER 208579636 REPACK(42472-002) , RELABEL(42472-002)
    Establishment
    Name Address ID/FEI Business Operations
    ESTEE LAUDER COSMETICS, LTD 253616536 MANUFACTURE(42472-002)
    Establishment
    Name Address ID/FEI Business Operations
    ESTEE LAUDER COSMETICS, LTD 244669714 MANUFACTURE(42472-002)
    Establishment
    Name Address ID/FEI Business Operations
    ESTEE LAUDER COSMETICS, LTD. 205952385 MANUFACTURE(42472-002)
    Establishment
    Name Address ID/FEI Business Operations
    ESTEE LAUDER N.V. 370151326 MANUFACTURE(42472-002)
    Establishment
    Name Address ID/FEI Business Operations
    LEN-RON MANUFACTURING DIVISION OF ARAMIS INC 809771152 MANUFACTURE(42472-002)
    Establishment
    Name Address ID/FEI Business Operations
    NORTEC KEYSTONE 943871157 MANUFACTURE(42472-002) , RELABEL(42472-002) , REPACK(42472-002)
    Establishment
    Name Address ID/FEI Business Operations
    NORTHTEC BRISTOL 959338336 MANUFACTURE(42472-002) , RELABEL(42472-002) , REPACK(42472-002)
    Establishment
    Name Address ID/FEI Business Operations
    NORTHTEC KEYSTONE 949264774 MANUFACTURE(42472-002) , RELABEL(42472-002) , REPACK(42472-002)
    Establishment
    Name Address ID/FEI Business Operations
    WHITMAN LABORATORIES, LTD. 216866277 MANUFACTURE(42472-002)
    Establishment
    Name Address ID/FEI Business Operations
    Aveda Corporation 071352058 MANUFACTURE(42472-002)
    Establishment
    Name Address ID/FEI Business Operations
    Pennsylvania Logistics Center 078364654 REPACK(42472-002) , RELABEL(42472-002)