Label: SENTE DAILY REPAIR COMPLEX SPF 30- titanium dioxide, zinc oxide cream

  • NDC Code(s): 59958-220-01, 59958-220-02
  • Packager: Owen Biosciences, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 5, 2024

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

  • Drug Facts

    Active ingredients                  Purpose

    (Zinc Oxide) 3.72%                 Sunscreen

    (Titanium Dioxide) 9.95%        Sunscreen

  • PURPOSE

    USES

    Helps protect against sunburn

    Higher SPF gives more sunburn protection

    Provides moderate protection against sunburn.

  • WARNINGS

    For external use only. When using this product keep

    out of eyes. Rinse with water to remove. Stop use and

    ask doctor if rash and irritation develops and lasts.

    Avoid contact with eyes. If product gets into eyes,

    rinse thoroughly with water.

    Keep out of reach of children. If swallowed, get

    medical help or contact poison control center right

    away.

    Keep Out of Reach of Children

    Keep out of reach of children. If swallowed, get medical help or contact poison control center right away.

  • INDICATIONS & USAGE

    Directions

    Apply evenly to skin before exposure to sun and as needed.

    Reapply as needed or after towel drying or swimming.

    For children under 6 months, ask a doctor.

  • INACTIVE INGREDIENT

    Inactive Ingredients

    Cyclopentasiloxane, Cyclo-methicone, Water (Aqua), Dimethicone/Vinyl Dimethicone Cross-polymer, Melanin, Tribehenin, Methyl Methacrylate/Glycol, Calcium Behenate, Sorbitan Isostearate, Dimethiconol, Heparan Sulfate, Alumina, PEG-10 Dimethicone, Silybin, Ascobyl Linoleate, Lysophosphatidic Acid, Plankton Extract, Methicone, hydrogen Dimethicone, Lauryl Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, CI 77492 (Iron Oxide), Polyaminopropyl Biguanide

  • Dosage & Administration

    Directions

    - Apply enenly to skin before exposure to sun and as needed

    - Reapply as needed or after towel drying or swimming

    - Children under 6 months, ask doctor

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    SENTE DAILY REPAIR COMPLEX  SPF 30
    titanium dioxide, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59958-220
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE9.95 g  in 100 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE3.72 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    TRIBEHENIN (UNII: 8OC9U7TQZ0) 1.25 g  in 100 g
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) 4.68 g  in 100 g
    WATER (UNII: 059QF0KO0R) 7 g  in 100 g
    CALCIUM BEHENATE (UNII: J5VFA9V6YG) 1.25 g  in 100 g
    MELANIN SYNTHETIC (TYROSINE, PEROXIDE) (UNII: O0CV1RMR44) 1.5 g  in 100 g
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4) 1.5 g  in 100 g
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) 0.5 g  in 100 g
    METHICONE (20 CST) (UNII: 6777U11MKT) 0.5 g  in 100 g
    DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6) 43 g  in 100 g
    METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: 657L0NC5MT) 2 g  in 100 g
    FERRIC OXIDE RED (UNII: 1K09F3G675) 0.116 g  in 100 g
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT) 0.116 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59958-220-021 in 1 BOX04/02/2015
    1NDC:59958-220-0130 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02004/02/2015
    Labeler - Owen Biosciences, Inc. (790003045)