Label: RE NUTRIV RADIANT UV BASE BROAD SPECTRUM SPF 50- homosalate , octyl salicylate, avobenzone, oxybenzone, octocrylene lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated April 24, 2012

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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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