SHISEIDO URBAN ENVIRONMENT FRESH-MOISTURE SUNSCREEN SPF 42- avobenzone, homosalate, octisalate, and octocrylene cream 
SHISEIDO AMERICAS CORPORATION

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.

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SHISEIDO URBAN ENVIRONMENT FRESH-MOISTURE SUNSCREEN SPF 42

Drug Facts

Active ingredientsPurpose
AVOBENZONE 2.3%Sunscreen
HOMOSALATE 10.0%Sunscreen
OCTISALATE 5.0%Sunscreen
OCTOCRYLENE 5.0%Sunscreen

Uses

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:

Inactive Ingredients

WATER▪BUTYLENE GLYCOL▪GLYCERIN▪CAPRYLYL METHICONE▪SILICA▪DIPROPYLENE GLYCOL▪GLYCERYL DIISOSTEARATE▪SD ALCOHOL 40-B▪PEG/PPG-14/7 DIMETHYL ETHER▪BEHENETH-20▪BEHENYL ALCOHOL▪C30-45 ALKYL METHICONE▪TREHALOSE▪AMMONIUM ACRYLOYLDIMETHYLTAURATE/BEHENETH-25 METHACRYLATE CROSSPOLYMER▪XANTHAN GUM▪ASCORBYL TETRAISOPALMITATE▪DIPOTASSIUM GLYCYRRHIZATE▪SODIUM HYALURONATE▪SANGUISORBA OFFICINALIS ROOT EXTRACT▪CAMELLIA SINENSIS LEAF EXTRACT▪GARCINIA MANGOSTANA BARK EXTRACT▪PERILLA OCYMOIDES LEAF EXTRACT▪SPIRULINA PLATENSIS EXTRACT▪C30-45 OLEFIN▪BIS-PEG-18 METHYL ETHER DIMETHYL SILANE▪STEARYL ALCOHOL▪DISODIUM EDTA▪POTASSIUM HYDROXIDE▪BHT▪TOCOPHEROL▪CARBOMER▪ALCOHOL▪SODIUM METABISULFITE▪SYNTHETIC FLUORPHLOGOPITE▪SODIUM CITRATE▪PHENOXYETHANOL▪FRAGRANCE▪MICA▪TITANIUM DIOXIDE▪

Other information

Questions or comments?

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PRINCIPAL DISPLAY PANEL - 50mL Tube Carton

SHISEIDO
GINZA TOKYO

Urban Environment
Sun Dual Care™

FRESH-MOISTURE
with HYALURONIC ACID

SPF
42

BROAD SPECTRUM SPF 42
SUNSCREEN

50mL NET WT. 1.8 OZ.

PRINCIPAL DISPLAY PANEL - 50mL Tube Carton
SHISEIDO URBAN ENVIRONMENT FRESH-MOISTURE SUNSCREEN SPF 42 
avobenzone, homosalate, octisalate, and octocrylene cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-671
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1.2 g  in 50 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE5.2 g  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2.6 g  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE2.6 g  in 50 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
GLYCERIN (UNII: PDC6A3C0OX)  
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
GLYCERYL DIISOSTEARATE (UNII: 68BAV42LRC)  
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  
BEHENETH-20 (UNII: BJ4GP2IFLN)  
DOCOSANOL (UNII: 9G1OE216XY)  
C30-45 ALKYL METHICONE (UNII: NFX970DSI2)  
TREHALOSE (UNII: B8WCK70T7I)  
AMMONIUM ACRYLOYLDIMETHYLTAURATE/BEHENETH-25 METHACRYLATE CROSSPOLYMER (52000 MPA.S) (UNII: LZ291VH90H)  
XANTHAN GUM (UNII: TTV12P4NEE)  
ASCORBYL TETRAISOPALMITATE (UNII: 47143LT58A)  
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
SANGUISORBA OFFICINALIS ROOT (UNII: 4NYV2HT01X)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
GARCINIA MANGOSTANA BARK (UNII: N6A4WY566I)  
PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)  
C30-45 OLEFIN (UNII: 6DWD51M0O8)  
BIS-PEG-18 METHYL ETHER DIMETHYL SILANE (UNII: OEB4R3WW9C)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
ALCOHOL (UNII: 3K9958V90M)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
MICA (UNII: V8A1AW0880)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-671-601 in 1 CARTON01/01/2022
150 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/01/2022
Labeler - SHISEIDO AMERICAS CORPORATION (193691821)

Revised: 11/2021
Document Id: 27da4c26-d21f-4dfb-8993-d820774363b5
Set id: 42adc51f-f500-485d-82a0-126672141262
Version: 1
Effective Time: 20211115
 
SHISEIDO AMERICAS CORPORATION