RE-NUTRIV ULTIMATE LIFTING MAKEUP SPF15 (TITANIUM DIOXIDE) CREAM [ESTEE LAUDER INC]

RE-NUTRIV ULTIMATE LIFTING MAKEUP SPF15 (TITANIUM DIOXIDE) CREAM [ESTEE LAUDER INC]
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NDC 11559-724-01
Set ID c3bf8902-2357-41b6-b1c3-b1e4efda48fa
Category HUMAN OTC DRUG LABEL
Packager ESTEE LAUDER INC
Generic Name
Product Class
Product Number
Application Number PART352
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Titanium Dioxide 1.40%

  • Purpose

    Sunscreen

  • Use

    helps prevent sunburn

  • 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

    For sunscreen use:

    • 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 • cyclopentasiloxane • butylene glycol • phenyl trimethicone • cetyl dimethicone • dimethicone • pentaerythrityl tetraethylhexanoate • octyldodecyl stearoyl stearate • peg/ppg-18/18 dimethicone • cetyl peg/ppg-10/1 dimethicone • magnesium sulfate • ethylhexyl palmitate • astrocaryum murumuru butter • pyrus malus (apple) fruit extract • silybum marianum (lady's thistle) extract • acetyl hexapeptide-8 • oryza sativa (rice) bran extract • pisum sativum (pea) extract • aminopropyl ascorbyl phosphate • tocopheryl acetate • palmitoyl oligopeptide • caffeine • linoleic acid • cholesterol • quaternium-90 bentonite • acetyl carnitine hcl • ascorbyl palmitate • disodium nadh • ethylhexylglycerin • 7-dehydrocholesterol • trimethylsiloxysilicate • tribehenin • phytosteryl/octyldodecyl lauroyl glutamate • methicone • zinc stearate • sorbitan isostearate • laureth-7 • sucrose • trifluoromethyl c1-4 alkyl dimethicone • glyceryl polymethacrylate • hydrolyzed fish (pisces) collagen • propylene carbonate • caprylyl glycol • sodium hyaluronate • peg-8 • hydrogenated lecithin • xanthan gum • alumina • fragrance (parfum) • sodium chloride • bht • chloroxylenol • phenoxyethanol • [+/- iron oxides (ci 77491, ci 77492, ci 77499) • titanium dioxide (ci 77891) • mica] <iln37196>

  • Other information

    protect the product in this container from excessive heat and direct sun

  • PRINCIPAL DISPLAY PANEL - 30 ml Container Carton

    ESTĒE LAUDER
    Re-Nutriv

    Ultimate Lifting Creme Makeup
    Broad Spectrum SPF 15

    Principal Display Panel - 30 ml Container Carton
  • INGREDIENTS AND APPEARANCE
    RE-NUTRIV   ULTIMATE LIFTING MAKEUP SPF15
    titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11559-724
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.4 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    cyclomethicone 5 (UNII: 0THT5PCI0R)  
    butylene glycol (UNII: 3XUS85K0RA)  
    phenyl trimethicone (UNII: DR0K5NOJ4R)  
    dimethicone (UNII: 92RU3N3Y1O)  
    pentaerythrityl tetraethylhexanoate (UNII: XJ7052W897)  
    octyldodecyl stearoyl stearate (UNII: 3D47Q6D93C)  
    peg/ppg-18/18 dimethicone (UNII: 9H0AO7T794)  
    magnesium sulfate (UNII: DE08037SAB)  
    ethylhexyl palmitate (UNII: 2865993309)  
    astrocaryum murumuru seed butter (UNII: 12V64UPU6R)  
    apple (UNII: B423VGH5S9)  
    milk thistle (UNII: 822I9LEJ7S)  
    acetyl hexapeptide-8 (UNII: L4EL31FWIL)  
    rice bran (UNII: R60QEP13IC)  
    pea (UNII: W4X7H8GYFM)  
    aminopropyl ascorbyl phosphate (UNII: 290O2PQ83R)  
    .alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
    palmitoyl oligopeptide (UNII: HO4ZT5S86C)  
    caffeine (UNII: 3G6A5W338E)  
    linoleic acid (UNII: 9KJL21T0QJ)  
    cholesterol (UNII: 97C5T2UQ7J)  
    acetylcarnitine hydrochloride (UNII: NDW10MX58T)  
    ascorbyl palmitate (UNII: QN83US2B0N)  
    ethylhexylglycerin (UNII: 147D247K3P)  
    7-dehydrocholesterol (UNII: BK1IU07GKF)  
    tribehenin (UNII: 8OC9U7TQZ0)  
    zinc stearate (UNII: H92E6QA4FV)  
    sorbitan isostearate (UNII: 01S2G2C1E4)  
    laureth-7 (UNII: Z95S6G8201)  
    sucrose (UNII: C151H8M554)  
    propylene carbonate (UNII: 8D08K3S51E)  
    caprylyl glycol (UNII: 00YIU5438U)  
    hyaluronate sodium (UNII: YSE9PPT4TH)  
    polyethylene glycol 400 (UNII: B697894SGQ)  
    hydrogenated soybean lecithin (UNII: H1109Z9J4N)  
    xanthan gum (UNII: TTV12P4NEE)  
    aluminum oxide (UNII: LMI26O6933)  
    sodium chloride (UNII: 451W47IQ8X)  
    butylated hydroxytoluene (UNII: 1P9D0Z171K)  
    chloroxylenol (UNII: 0F32U78V2Q)  
    phenoxyethanol (UNII: HIE492ZZ3T)  
    ferric oxide red (UNII: 1K09F3G675)  
    ferric oxide yellow (UNII: EX438O2MRT)  
    ferrosoferric oxide (UNII: XM0M87F357)  
    mica (UNII: V8A1AW0880)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11559-724-011 in 1 CARTON
    130 mL in 1 CONTAINER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35201/01/2005
    Labeler - ESTEE LAUDER INC (005914387)
    Establishment
    NameAddressID/FEIBusiness Operations
    ELGC K.K.712808195RELABEL(11559-724) , REPACK(11559-724)
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder Pennsylvania Distribution Center 2 (PADC 2)828534516MANUFACTURE(11559-724) , RELABEL(11559-724) , REPACK(11559-724)
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder Inc.042918826MANUFACTURE(11559-724)
    Establishment
    NameAddressID/FEIBusiness Operations
    ESTEE LAUDER COSMETICS DISTRIBUTION CENTER208579636REPACK(11559-724) , RELABEL(11559-724)
    Establishment
    NameAddressID/FEIBusiness Operations
    ESTEE LAUDER COSMETICS, LTD253616536MANUFACTURE(11559-724)
    Establishment
    NameAddressID/FEIBusiness Operations
    ESTEE LAUDER COSMETICS, LTD244669714MANUFACTURE(11559-724)
    Establishment
    NameAddressID/FEIBusiness Operations
    ESTEE LAUDER COSMETICS, LTD.205952385MANUFACTURE(11559-724)
    Establishment
    NameAddressID/FEIBusiness Operations
    ESTEE LAUDER N.V.370151326MANUFACTURE(11559-724)
    Establishment
    NameAddressID/FEIBusiness Operations
    LEN-RON MANUFACTURING DIVISION OF ARAMIS INC809771152MANUFACTURE(11559-724)
    Establishment
    NameAddressID/FEIBusiness Operations
    NORTEC KEYSTONE943871157MANUFACTURE(11559-724) , RELABEL(11559-724) , REPACK(11559-724)
    Establishment
    NameAddressID/FEIBusiness Operations
    NORTHTEC BRISTOL959338336MANUFACTURE(11559-724) , RELABEL(11559-724) , REPACK(11559-724)
    Establishment
    NameAddressID/FEIBusiness Operations
    NORTHTEC KEYSTONE949264774MANUFACTURE(11559-724) , RELABEL(11559-724) , REPACK(11559-724)
    Establishment
    NameAddressID/FEIBusiness Operations
    WHITMAN LABORATORIES, LTD.216866277MANUFACTURE(11559-724)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aveda Corporation071352058MANUFACTURE(11559-724)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pennsylvania Logistics Center078364654REPACK(11559-724) , RELABEL(11559-724)

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