Label: RE-NUTRIV ULTRA RADIANCE MAKEUP BROAD SPECTRUM SPF 20- octinoxate and titanium dioxide liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 30, 2024

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    Octinoxate 2.2%Sunscreen
    Titanium Dioxide 1.4%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 • phenyl trimethicone • methyl trimethicone • dimethicone • butylene glycol • isocetyl alcohol • peg/ppg-18/18 dimethicone • rhodochrosite extract • caprylic/capric triglyceride • isohexadecane • sorbitan sesquioleate • magnesium sulfate • wheat germ glycerides • tribehenin • olivine extract • laminaria digitata extract • sodium hyaluronate • trifluoroacetyl tripeptide-2 • palmitoyl tripeptide-1 • pearl powder • gold • ruby powder • sapphire powder • nephrite powder • citrullus vulgaris (watermelon) fruit extract • pyrus malus (apple) fruit extract • lens esculenta (lentil) fruit extract • algae extract • oryza sativa (rice) bran extract • gentiana lutea (gentian) root extract • ascorbyl palmitate • ergothioneine • simmondsia chinensis (jojoba) seed oil • tocopheryl acetate • hydrolyzed wheat protein • linoleic acid • laureth-7 • triethyl citrate • stearic acid • ethylhexylglycerin • polymethylsilsesquioxane • cholesterol • hydrogenated lecithin • glycerin • ethylhexyl palmitate • propylene carbonate • polyphenylsilsesquioxane • polysilicone-11 • sodium lactate • triethoxycaprylylsilane • tocopherol • sodium pca • sorbitan isostearate • sorbitan stearate • magnesium ascorbyl phosphate • aluminum hydroxide • methicone • xanthan gum • cetyl peg/ppg-10/1 dimethicone • lauryl peg-9 polydimethylsiloxyethyl dimethicone • disteardimonium hectorite • dextran • boron nitride • sodium metabisulfite • fragrance (parfum) • bht • pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate • sorbic acid • sodium benzoate • potassium sorbate • chloroxylenol • phenoxyethanol • [+/- mica • titanium dioxide (ci 77891) • iron oxides (ci 77492) • iron oxides (ci 77491) • iron oxides (ci 77499)] <iln46282>

  • Other information

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

  • PRINCIPAL DISPLAY PANEL - 30 ml Tube Carton

    Re-Nutriv

    ESTĒE LAUDER

    Ultra Radiance

    Liquid Makeup

    Broad Spectrum

    SPF 20

    1 FL. OZ. LIQ.

    30 ml e

    Principal Display Panel

  • INGREDIENTS AND APPEARANCE
    RE-NUTRIV ULTRA RADIANCE MAKEUP BROAD SPECTRUM SPF 20 
    octinoxate and titanium dioxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11559-057
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE22 mg  in 1 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE14 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    METHYL TRIMETHICONE (UNII: S73ZQI0GXM)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ISOCETYL ALCOHOL (UNII: 1800H64066)  
    PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    WHEAT GERM OIL (UNII: 14C97E680P)  
    TRIBEHENIN (UNII: 8OC9U7TQZ0)  
    LAMINARIA DIGITATA (UNII: 15E7C67EE8)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)  
    PEARL (HYRIOPSIS CUMINGII) (UNII: A75L5FZ40U)  
    GOLD (UNII: 79Y1949PYO)  
    WATERMELON (UNII: 231473QB6R)  
    APPLE (UNII: B423VGH5S9)  
    LENS CULINARIS FRUIT (UNII: ZYZ076G9JH)  
    RICE BRAN (UNII: R60QEP13IC)  
    GENTIANA LUTEA ROOT (UNII: S72O3284MS)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    ERGOTHIONEINE (UNII: BDZ3DQM98W)  
    JOJOBA OIL (UNII: 724GKU717M)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    HYDROLYZED WHEAT PROTEIN (ENZYMATIC; 3000 MW) (UNII: J2S07SB0YL)  
    LINOLEIC ACID (UNII: 9KJL21T0QJ)  
    LAURETH-7 (UNII: Z95S6G8201)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    SODIUM LACTATE (UNII: TU7HW0W0QT)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    METHICONE (20 CST) (UNII: 6777U11MKT)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    BORON NITRIDE (UNII: 2U4T60A6YD)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
    SORBIC ACID (UNII: X045WJ989B)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    CHLOROXYLENOL (UNII: 0F32U78V2Q)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    MICA (UNII: V8A1AW0880)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11559-057-011 in 1 CARTON07/15/2019
    130 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02007/15/2019
    Labeler - ESTEE LAUDER INC (005914387)
    Registrant - Estee Lauder Companies Inc. (790802086)
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder N.V.370151326manufacture(11559-057) , pack(11559-057) , label(11559-057)
    Establishment
    NameAddressID/FEIBusiness Operations
    Olen Cosmetics295870216pack(11559-057) , label(11559-057)