SHISEIDO URBAN ENVIRONMENT OIL-FREE UV PROTECTOR

SHISEIDO URBAN ENVIRONMENT oil-FREE UV PROTECTOR by

Drug Labeling and Warnings

SHISEIDO URBAN ENVIRONMENT oil-FREE UV PROTECTOR by is a Otc medication manufactured, distributed, or labeled by SHISEIDO AMERICAS CORPORATION. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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SHISEIDO URBAN ENVIRONMENT OIL-FREE UV PROTECTOR

Drug Facts

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
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 CARTON01/01/202101/01/2024
150 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC: 58411-627-611 in 1 CARTON01/01/202101/01/2024
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 DRUGM02001/01/202101/01/2024
Labeler - SHISEIDO AMERICAS CORPORATION (193691821)

Revised: 12/2024