Label: SHISEIDO URBAN ENVIRONMENT OIL-FREE UV PROTECTOR- zinc oxide, homosalate, octocrylene, and octisalate emulsion

  • NDC Code(s): 58411-627-60, 58411-627-61
  • Packager: SHISEIDO AMERICAS CORPORATION
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 January 12, 2021

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    HOMOSALATE 5.0%Sunscreen
    OCTISALATE 5.0%Sunscreen
    OCTOCRYLENE 5.0%Sunscreen
    ZINC OXIDE 9.7%Sunscreen
  • Uses

    • helps prevent sunburn
    • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun
  • 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.

    Flammable: Do not use near heat, flame, or while smoking.

  • Directions

    For sunscreen use:

    • apply liberally 15 minutes before sun exposure
    • reapply:
      • after 40 minutes of swimming or sweating
      • immediately after towel drying
      • at least every two hours
    • 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 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-sleeve shirts, pants, hats, and sunglasses
      • wear long-sleeve shirts, pants, hats, and sunglasses
      • children under 6 months: Ask a doctor
  • Inactive Ingredients

    WATER∙ISODODECANE∙DIMETHICONE∙SD ALCOHOL 40-B∙DIPROPYLENE GLYCOL∙ETHYLHEXYL PALMITATE∙PEG-10 DIMETHICONE∙GLYCERIN∙POLYMETHYLSILSESQUIOXANE∙VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER∙POLYBUTYLENE GLYCOL/PPG-9/1 COPOLYMER∙XYLITOL∙SILICA∙METHYL METHACRYLATE CROSSPOLYMER∙THIOTAURINE∙SCUTELLARIA BAICALENSIS ROOT EXTRACT∙PAEONIA ALBIFLORA ROOT EXTRACT∙ONONIS SPINOSA ROOT EXTRACT∙ECTOIN∙LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE∙HYDROGEN DIMETHICONE∙BUTYLENE GLYCOL∙DISODIUM EDTA∙DISTEARDIMONIUM HECTORITE∙TOCOPHEROL∙ALUMINUM HYDROXIDE∙TRIETHOXYCAPRYLYLSILANE∙SODIUM METABISULFITE∙SYZYGIUM JAMBOS LEAF EXTRACT∙PHENOXYETHANOL∙BENZOIC ACID∙FRAGRANCE∙TITANIUM DIOXIDE∙MICA∙

  • Other information

    Protect this product in this container from excessive heat and direct sun.

  • Questions or comments?

    Call toll free 1-800-906-7503

  • PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton

    SHISEIDO
    GINZA TOKYO

    Urban Environment
    Oil-Free UV Protector

    42

    BROAD SPECTRUM
    SPF 42

    For Face

    WATER RESISTANT
    (40 MINUTES)

    SUNSCREEN

    50mL 1.6 FL. OZ.

    Principal Display Panel - 50 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    SHISEIDO URBAN ENVIRONMENT OIL-FREE UV PROTECTOR 
    zinc oxide, homosalate, octocrylene, and octisalate emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-627
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE5.16 g  in 50 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE2.65 g  in 50 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE2.65 g  in 50 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2.65 g  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ISODODECANE (UNII: A8289P68Y2)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    XYLITOL (UNII: VCQ006KQ1E)  
    METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)  
    LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    THIOTAURINE (UNII: NQZ2D7AO62)  
    SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)  
    MICA (UNII: V8A1AW0880)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)  
    ECTOINE (UNII: 7GXZ3858RY)  
    SYZYGIUM JAMBOS LEAF (UNII: 407Z4W5LFF)  
    ONONIS SPINOSA ROOT (UNII: FD2FMC53M1)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58411-627-601 in 1 CARTON01/01/2021
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:58411-627-611 in 1 CARTON01/01/2021
    230 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35201/01/2021
    Labeler - SHISEIDO AMERICAS CORPORATION (193691821)