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

SHISEIDO URBAN ENVIRONMENT FRESH-MOISTURE SUNSCREEN SPF 42 by

Drug Labeling and Warnings

SHISEIDO URBAN ENVIRONMENT FRESH-MOISTURE SUNSCREEN SPF 42 by is a Otc medication manufactured, distributed, or labeled by SHISEIDO AMERICAS CORPORATION. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
AVOBENZONE 2.3%	Sunscreen
HOMOSALATE 10.0%	Sunscreen
OCTISALATE 5.0%	Sunscreen
OCTOCRYLENE 5.0%	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.

Directions

For sunscreen use:

• apply liberally 15 minutes before sun exposure
• use a water resistant sunscreen if swimming or sweating
• reapply at least every 2 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 un protection measures including:
  • limit time in the sun, especially from 10 a.m. – 2 p.m.
  • wear long-sleeve shirts, pants, hats, and sunglasses
• children under 6 months: Ask a doctor

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

• 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 - 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.

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-671
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1.2 g  in 50 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	5.2 g  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	2.6 g  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2.6 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-671-60	1 in 1 CARTON	01/01/2022
1		50 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	01/01/2022

Labeler - SHISEIDO AMERICAS CORPORATION (193691821)