RE NUTRIV RADIANT UV BASE BROAD SPECTRUM SPF 50 (HOMOSALATE , OCTYL SALICYLATE, AVOBENZONE, OXYBENZONE, OCTOCRYLENE) LOTION [ESTEE LAUDER INC]

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  • RE NUTRIV RADIANT UV BASE BROAD SPECTRUM SPF 50 (HOMOSALATE , OCTYL SALICYLATE, AVOBENZONE, OXYBENZONE, OCTOCRYLENE) LOTION [ESTEE LAUDER INC]

RE NUTRIV RADIANT UV BASE BROAD SPECTRUM SPF 50 (HOMOSALATE , OCTYL SALICYLATE, AVOBENZONE, OXYBENZONE, OCTOCRYLENE) LOTION [ESTEE LAUDER INC]
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NDC 11559-017-01, 11559-017-02
Set ID 413949ef-08c0-412a-8fdf-c8c27093d7c3
Category HUMAN OTC DRUG LABEL
Packager ESTEE LAUDER INC
Generic Name
Product Class
Product Number
Application Number PART352
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  • SPL UNCLASSIFIED SECTION

    DRUG FACTS

  • ACTIVE INGREDIENTS:

    AVOBENZONE 3.00%

    HOMOSALATE 5.00%

    OCTOCRYLENE 2.70%

    OCTISALATE 5.00%

    OXYBENZONE 3.00%

  • PURPOSE

    SUNSCREEN

  • USE

    HELPS PREVENT SUNBURN

  • WARNINGS

    FOR EXTERNAL USE ONLY

  • DO NOT USE

    Do not use on damaged or broken skin

  • WHEN USING

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

  • STOP USE

    Stop use and ask a doctor if rash occurs

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • SPL UNCLASSIFIED SECTION

    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:
              o limit time in the sun, especially from 10 a.m.–2 p.m.
              o wear long-sleeved shirts, pants, hats and sunglasses
        * children under 6 months of age: ask a doctor

  • INACTIVE INGREDIENTS

    WATER\AQUA\EAU [] BUTYLOCTYL SALICYLATE [] METHYL TRIMETHICONE [] NEOPENTYL GLYCOL DIHEPTANOATE [] ALEURITES MOLUCCANA (KUKUI) SEED OIL [] LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE [] PEG-100 STEARATE [] BUTYLENE GLYCOL [] DIPENTAERYTHRITYL TRI-POLYHYDROXYSTEARATE [] GLYCERYL STEARATE [] ALGAE EXTRACT [] LAMINARIA OCHROLEUCA EXTRACT [] LAMINARIA DIGITATA EXTRACT [] CETYL ALCOHOL [] CAFFEINE [] HYDROLYZED WHEAT PROTEIN [] VP/EICOSENE COPOLYMER [] PEARL POWDER [] GOLD [] SODIUM HYALURONATE [] ERGOTHIONEINE [] STEARIC ACID [] DEHYDROXANTHAN GUM [] POTASSIUM CETYL PHOSPHATE [] ETHYLHEXYLGLYCERIN [] AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER [] SACCHARIDE ISOMERATE [] CAPRYLYL GLYCOL [] GLYCERIN [] SORBITOL [] SILICA [] CAPRYLIC/CAPRIC TRIGLYCERIDE [] FRAGRANCE (PARFUM) [] DISODIUM EDTA [] CITRIC ACID [] PHENOXYETHANOL [] SODIUM DEHYDROACETATE [] MICA [] TITANIUM DIOXIDE (CI 77891) [] RED 33 (CI 17200) [] BLUE 1 (CI 42090)

  • OTHER INFORMATION

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

  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL:

    ESTEE LAUDER

    RE-NUTRIV

    RADIANT UV BASE

    BROAD SPECTRUM

    SPF 50



    1FL OZ LIQ / 30 ML




    ESTEE LAUDER DIST
    NY, NY 10022

    FOLDING CARTON



  • INGREDIENTS AND APPEARANCE
    RE NUTRIV RADIANT UV BASE  BROAD SPECTRUM SPF 50
    homosalate , octyl salicylate, avobenzone, oxybenzone, octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11559-017
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE5.0 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
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE3.0 nmol  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE2.7 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    METHYL TRIMETHICONE (UNII: S73ZQI0GXM)  
    NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
    KUKUI NUT (UNII: J87WJ3E7VW)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    NORI (UNII: 477TV3P5UX)  
    LAMINARIA DIGITATA (UNII: 15E7C67EE8)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CAFFEINE (UNII: 3G6A5W338E)  
    HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) (UNII: J2S07SB0YL)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    ERGOTHIONEINE (UNII: BDZ3DQM98W)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SORBITOL (UNII: 506T60A25R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    MICA (UNII: V8A1AW0880)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11559-017-011 in 1 CARTON
    1NDC:11559-017-0230 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35204/01/2012
    Labeler - ESTEE LAUDER INC (005914387)
    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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