SHISEIDO URBAN ENVIRONMENT- ensulizole, homosalate, octisalate, zinc oxide emulsion

SHISEIDO URBAN ENVIRONMENT by

Drug Labeling and Warnings

SHISEIDO URBAN ENVIRONMENT 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
• Ensulizole 1.0%: Sunscreen
• Homosalate 15.0%: Sunscreen
• Octisalate 5.0%: Sunscreen
• Zinc Oxide 15.5%: Sunscreen

Uses

• help 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 on damaged or broken skin

WHEN USING

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

STOP USE

Stop use and ask a doctor if 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.

WARNINGS AND PRECAUTIONS

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 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. - 2 p.m.

       wear long-sleeve shirts, pants, hats, and sunglasses

       children under 6 months: Ask a doctor

INACTIVE INGREDIENT

WATER･DIMETHICONE･TRISILOXANE･SD ALCOHOL 40-B･ZINC OXIDE･GLYCERIN･SILICA･PEG/PPG-14/7 DIMETHYL ETHER･LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE･PEG-10 DIMETHICONE･TREHALOSE･MYRISTYL MYRISTATE･ETHYLHEXYL PALMITATE･DEXTRIN PALMITATE･ISODECYL NEOPENTANOATE･ASCORBYL TETRAISOPALMITATE･THIOTAURINE･DIPOTASSIUM GLYCYRRHIZATE･SCUTELLARIA BAICALENSIS ROOT EXTRACT･PAEONIA ALBIFLORA ROOT EXTRACT･SODIUM HYALURONATE･SANGUISORBA OFFICINALIS ROOT EXTRACT･CAMELLIA SINENSIS LEAF EXTRACT･GARCINIA MANGOSTANA BARK EXTRACT･PERILLA OCYMOIDES LEAF EXTRACT･SPIRULINA PLATENSIS EXTRACT･TRIETHANOLAMINE･TRIETHOXYCAPRYLYLSILANE･BUTYLENE GLYCOL･DISODIUM EDTA･DISTEARDIMONIUM HECTORITE･TOCOPHEROL･BHT･ALCOHOL･ISOSTEARIC ACID･MENTHOXYPROPANEDIOL･SODIUM METABISULFITE･POLYSILICONE-2･BARIUM SULFATE･SODIUM CITRATE･PHENOXYETHANOL･BENZOIC ACID･FRAGRANCE･IRON OXIDES･

Other information

• protect this product in this container from excessive heat and direct sunlight

Questions or Comments?

Call toll free 1-800-906-7503

PRINCIPAL DISPLAY PANEL

SHISEIDO 

Ginza Tokyo

Urban Environment

Sun Dual Care

OIL-FREE

with HYALURONIC ACID

SPF 42

BROAD SPECTRUM SPF 42

WATER RESISTANT (40 MINUTES)

SUNSCREEN

50mL 1.6 FL. OZ.

INGREDIENTS AND APPEARANCE

SHISEIDO URBAN ENVIRONMENT 
ensulizole, homosalate, octisalate, zinc oxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-952
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42)	ENSULIZOLE	0.6 g  in 50 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	9 g  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (ETHYLHEXYL SALICYLATE - UNII:4X49Y0596W)	OCTISALATE	3 g  in 50 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	9.3 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
TRISILOXANE (UNII: 9G1ZW13R0G)
ALCOHOL (UNII: 3K9958V90M)
GLYCERIN (UNII: PDC6A3C0OX)
SILICA (UNII: ETJ7Z6XBU4)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
PEG-10 DIMETHICONE (200 CST) (UNII: 287GF3Y3WC)
TREHALOSE (UNII: B8WCK70T7I)
MYRISTYL MYRISTATE (UNII: 4042ZC00DY)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3)
ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)
ASCORBYL TETRAISOPALMITATE (UNII: 47143LT58A)
THIOTAURINE (UNII: NQZ2D7AO62)
DIPOTASSIUM GLYCYRRHIZATE (UNII: CA2Y0FE3FX)
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)
PAEONIA ALBIFLORA FLOWER (UNII: R73687A534)
SODIUM HYALURONATE (UNII: YSE9PPT4TH)
SANGUISORBA OFFICINALIS ROOT (UNII: 4NYV2HT01X)
CAMELLIA SINENSIS LEAF (UNII: W2ZU1RY8B0)
GARCINIA MANGOSTANA BARK (UNII: N6A4WY566I)
PERILLA OCYMOIDES SEED OIL (UNII: 322MS57V7Z)
SPIRULINA PLATENSIS (UNII: 9L3TIH1UUE)
TRIETHANOLAMINE (UNII: 9O3K93S3TK)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
EDETATE DISODIUM (UNII: 7FLD91C86K)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
TOCOPHEROL (UNII: R0ZB2556P8)
BHT (UNII: 1P9D0Z171K)
ISOSTEARIC ACID (UNII: X33R8U0062)
MENTHOXYPROPANEDIOL (UNII: KD6TZ2QICH)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
BARIUM SULFATE (UNII: 25BB7EKE2E)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BENZOIC ACID (UNII: 8SKN0B0MIM)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Product Characteristics
Color	red	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-952-10	1 in 1 BOX	12/11/2027
1		50 mL in 1 BOTTLE, PLASTIC; 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	12/11/2025

Labeler - Shiseido Americas Corporation (193691821)

Establishment
Name	Address	ID/FEI	Business Operations
Shiseido America Inc.		782677132	manufacture(58411-952) , analysis(58411-952)