Label: RE-NUTRIV ULTRA RADIANCE MAKEUP BROAD SPECTRUM SPF 20- octinoxate and titanium dioxide liquid
- NDC Code(s): 11559-057-01
- Packager: ESTEE LAUDER INC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 30, 2024
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Use
- Warnings
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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
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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
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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
- PRINCIPAL DISPLAY PANEL - 30 ml Tube Carton
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INGREDIENTS AND APPEARANCE
RE-NUTRIV ULTRA RADIANCE MAKEUP BROAD SPECTRUM SPF 20
octinoxate and titanium dioxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11559-057 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 22 mg in 1 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 14 mg in 1 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:11559-057-01 1 in 1 CARTON 07/15/2019 1 30 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 07/15/2019 Labeler - ESTEE LAUDER INC (005914387) Registrant - Estee Lauder Companies Inc. (790802086) Establishment Name Address ID/FEI Business Operations Estee Lauder N.V. 370151326 manufacture(11559-057) , pack(11559-057) , label(11559-057) Establishment Name Address ID/FEI Business Operations Olen Cosmetics 295870216 pack(11559-057) , label(11559-057)