LAB SERIES SKINCARE FOR MEN DAILY MOISTURE DEFENSE BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTINOXATE, AND OCTISALATE) LOTION [ARAMIS INC.]

LAB SERIES SKINCARE FOR MEN DAILY MOISTURE DEFENSE BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTINOXATE, AND OCTISALATE) LOTION [ARAMIS INC.]
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NDC 42472-887-01
Set ID af05f2b7-bd7f-42a0-8042-92a0e07f0c36
Category HUMAN OTC DRUG LABEL
Packager ARAMIS INC.
Generic Name
Product Class
Product Number
Application Number PART352
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active IngredientPurpose
    Avobenzone 2.00%Sunscreen
    Octinoxate 7.50%Sunscreen
    Octisalate 3.00%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\AQUA\EAU • BUTYLENE GLYCOL • SILICA • HYDROGENATED POLYISOBUTENE • NEOPENTYL GLYCOL DIETHYLHEXANOATE • CYCLOPENTASILOXANE • PENTYLENE GLYCOL • HYDROGENATED LECITHIN • ETHYLBISIMINOMETHYLGUAIACOL MANGANESE CHLORIDE • SACCHAROMYCES LYSATE EXTRACT • ACETYL CARNITINE HCL • BETULA ALBA (BIRCH) BARK EXTRACT • PHYTOSPHINGOSINE • CREATINE • OCTYLDODECYL NEOPENTANOATE • COFFEA ROBUSTA SEED EXTRACT • ASTROCARYUM MURUMURU SEED BUTTER • ASCORBYL TOCOPHERYL MALEATE • ACETYL GLUCOSAMINE • LINOLEIC ACID • SODIUM HYALURONATE • TOCOPHERYL ACETATE • CETEARYL ALCOHOL • POLYPHOSPHORYLCHOLINE GLYCOL ACRYLATE • ACRYLAMIDE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER • PHOSPHOLIPIDS • ETHYLHEXYLGLYCERIN • ISOHEXADECANE • CHOLESTEROL • NEOPENTYL GLYCOL DIISOSTEARATE • ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER • CAPRYLIC/CAPRIC TRIGLYCERIDE • GLYCERIN • LECITHIN • BEHENYL ALCOHOL • ROSMARINUS OFFICINALIS (ROSEMARY) LEAF EXTRACT • CHAMOMILLA RECUTITA (MATRICARIA) • ETHYLHEXYL STEARATE • CARBOMER • ETHYLHEXYL PALMITATE • PROPYLENE GLYCOL DICAPRATE • CYCLODEXTRIN • NORDIHYDROGUAIARETIC ACID • SODIUM DNA • LINOLENIC ACID • TRIETHANOLAMINE • SODIUM HYDROXIDE • POLYSORBATE 80 • HEXYLENE GLYCOL • DISODIUM EDTA • POTASSIUM SORBATE • SODIUM DEHYDROACETATE • CHLORPHENESIN • PHENOXYETHANOL • SORBIC ACID <ILN37073>

  • Other information

    • Protect the product in this container from excessive heat and direct sun
  • PRINCIPAL DISPLAY PANEL - 100 ml Tube Carton

    LAB
    SERIES
    SKINCARE FOR MEN

    DAILY MOISTURE
    DEFENSE LOTION
    BROAD SPECTRUM
    SPF 15

    fragrance free

    TREAT

    3.4 FL. OZ./OZ. LIQ.
    100 ml e

    Principal Display Panel - 100 ml Tube Carton
  • INGREDIENTS AND APPEARANCE
    LAB SERIES SKINCARE FOR MEN DAILY MOISTURE DEFENSE BROAD SPECTRUM SPF 15 
    avobenzone, octinoxate, and octisalate lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42472-887
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE0.0212 g  in 100 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.0795 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE0.0318 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    NEOPENTYL GLYCOL DIETHYLHEXANOATE (UNII: U68ZV6W62C)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    ETHYLBISIMINOMETHYLGUAIACOL MANGANESE CHLORIDE (UNII: SM5YJ88LTU)  
    SACCHAROMYCES LYSATE (UNII: R85W246Z1C)  
    ACETYLCARNITINE HYDROCHLORIDE (UNII: NDW10MX58T)  
    BETULA PUBESCENS BARK (UNII: 3R504894L9)  
    PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)  
    CREATINE (UNII: MU72812GK0)  
    OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
    ROBUSTA COFFEE BEAN (UNII: V5032728L7)  
    ASTROCARYUM MURUMURU SEED BUTTER (UNII: 12V64UPU6R)  
    ASCORBYL TOCOPHERYL MALEATE (UNII: D2G6259XR5)  
    N-ACETYLGLUCOSAMINE (UNII: V956696549)  
    LINOLEIC ACID (UNII: 9KJL21T0QJ)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    NEOPENTYL GLYCOL DIISOSTEARATE (UNII: 4M6OQ34JWW)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    ROSEMARY (UNII: IJ67X351P9)  
    MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ)  
    ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    PROPYLENE GLYCOL DICAPRATE (UNII: U783H9JHWY)  
    MASOPROCOL (UNII: 7BO8G1BYQU)  
    LINOLENIC ACID (UNII: 0RBV727H71)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SORBIC ACID (UNII: X045WJ989B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42472-887-011 in 1 CARTON01/01/2005
    1100 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35201/01/2005
    Labeler - ARAMIS INC. (042918826)
    Establishment
    NameAddressID/FEIBusiness Operations
    ESTEE LAUDER COMPANY, THE828534516RELABEL(42472-887) , REPACK(42472-887)
    Establishment
    NameAddressID/FEIBusiness Operations
    ESTEE LAUDER COSMETICS, LTD244669714MANUFACTURE(42472-887)
    Establishment
    NameAddressID/FEIBusiness Operations
    ESTEE LAUDER COSMETICS, LTD.202952982MANUFACTURE(42472-887)
    Establishment
    NameAddressID/FEIBusiness Operations
    ESTEE LAUDER N.V.370151326MANUFACTURE(42472-887)
    Establishment
    NameAddressID/FEIBusiness Operations
    LEN-RON MANUFACTURING DIVISION OF ARAMIS INC809771152MANUFACTURE(42472-887)
    Establishment
    NameAddressID/FEIBusiness Operations
    NORTHTEC INC943871157RELABEL(42472-887) , REPACK(42472-887)
    Establishment
    NameAddressID/FEIBusiness Operations
    PADC 1949264774RELABEL(42472-887) , REPACK(42472-887)
    Establishment
    NameAddressID/FEIBusiness Operations
    WHITMAN LABORATORIES, LTD.216866277MANUFACTURE(42472-887)
    Establishment
    NameAddressID/FEIBusiness Operations
    ESTEE LAUDER COSMETICS, LTD255175580MANUFACTURE(42472-887)

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