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

SHISEIDO URBAN ENVIRONMENT FRESH-MOISTURE SUNSCREEN by

Drug Labeling and Warnings

SHISEIDO URBAN ENVIRONMENT FRESH-MOISTURE SUNSCREEN by is a Otc medication manufactured, distributed, or labeled by Shiseido Americas Corporation, Shiseido America Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

PURPOSE

Active Ingredients	Purpose
Avobenzone 2.3%	Sunscreen
Homosalate 10%
Octisalate 5.0%
Octocrylene 5.0%

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

Do not use ondamaged or broken skin

WHEN USING

When using this productkeep out of eyes. Rinse with water to remove.

STOP USE

Stop use and ask a doctorif rash occurs

KEEP OUT OF REACH OF CHILDREN

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 sun protection measures including:
•    limit time in the sun, especially from 10 a.m. - 2p.m.
•    wear long-sleeve shirts, pant, hats, and sunglasses
• children under 6 months: Ask a doctor

INACTIVE INGREDIENT

WATER･BUTYLENE GLYCOL･DIPROPYLENE GLYCOL･GLYCERIN･SD ALCOHOL 40-B･CAPRYLYL METHICONE･SILICA･GLYCERYL DIISOSTEARATE･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･CARBOMER･ALCOHOL･SODIUM METABISULFITE･MICA･SYNTHETIC FLUORPHLOGOPITE･TOCOPHEROL･SODIUM CITRATE･PHENOXYETHANOL･CHLORPHENESIN･FRAGRANCE･TITANIUM DIOXIDE･

Questions or Comments?

Call toll free 1-800-906-7503

Other Information

• protect this product in this container from excessive heat and direct sun.

PRINCIPLE DISPLAY PANNEL 50 mL TUBE

SHISEIDO

GINZA TOKYO

Urban Environment

FRESH-MOISTURE

SUNSCREEN

SPF 40

Daily Protection & Age Defense

BROAD SPECTRUM SPF 40

50 mL NET WT.17 OZ.

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-970
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1.1845 g  in 50 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	5.15 g  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (ETHYLHEXYL SALICYLATE - UNII:4X49Y0596W)	OCTISALATE	2.575 g  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2.575 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
GLYCERIN (UNII: PDC6A3C0OX)
CAPRYLYL METHICONE (UNII: Q95M2P1KJL)
SILICA (UNII: ETJ7Z6XBU4)
GLYCERYL DIISOSTEARATE (UNII: 68BAV42LRC)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
TREHALOSE (UNII: B8WCK70T7I)
C30-45 ALKYL METHICONE (UNII: NFX970DSI2)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/BEHENETH-25 METHACRYLATE CROSSPOLYMER (52000 MPA.S) (UNII: LZ291VH90H)
XANTHAN GUM (UNII: TTV12P4NEE)
ASCORBYL TETRAISOPALMITATE (UNII: 47143LT58A)
DIPOTASSIUM GLYCYRRHIZATE (UNII: CA2Y0FE3FX)
SODIUM HYALURONATE (UNII: YSE9PPT4TH)
SANGUISORBA OFFICINALIS ROOT (UNII: 4NYV2HT01X)
CAMELLIA SINENSIS LEAF (UNII: W2ZU1RY8B0)
GARCINIA MANGOSTANA BARK (UNII: N6A4WY566I)
PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)
SPIRULINA PLATENSIS (UNII: 9L3TIH1UUE)
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)
BHT (UNII: 1P9D0Z171K)
CARBOMER (UNII: 0A5MM307FC)
ALCOHOL (UNII: 3K9958V90M)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
MICA (UNII: V8A1AW0880)
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)
TOCOPHEROL (UNII: R0ZB2556P8)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CHLORPHENESIN (UNII: I670DAL4SZ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-970-60	1 in 1 BOX	02/01/2025
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	02/01/2025

Labeler - Shiseido Americas Corporation (193691821)

Establishment
Name	Address	ID/FEI	Business Operations
Shiseido America Inc.		782677132	manufacture(58411-970) , analysis(58411-970)