SHISEIDO URBAN ENVIRONMENT OIL-FREE SUNSCREEN SPF 42- ensulizole, homosalate, octisalate, and zinc oxide emulsion

SHISEIDO URBAN ENVIRONMENT Oil-Free SUNSCREEN SPF 42 by

Drug Labeling and Warnings

SHISEIDO URBAN ENVIRONMENT Oil-Free 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
ENSULIZOLE 1.0%	Sunscreen
HOMOSALATE 15.0%	Sunscreen
OCTISALATE 5.0%	Sunscreen
ZINC OXIDE 15.5%	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 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 Ingredients

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 sun.

Questions or comments?

Call toll free 1-800-906-7503

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton

SHISEIDO
GINZA TOKYO

Urban Environment

Sun Dual Care™

OIL-FREE
with HYALURONIC ACID

SPF
42

BROAD SPECTRUM SPF 42
WATER RESISTANT (40 MINUTES)
SUNSCREEN

30mL 1 FL. OZ.

INGREDIENTS AND APPEARANCE

SHISEIDO URBAN ENVIRONMENT OIL-FREE SUNSCREEN SPF 42 
ensulizole, homosalate, octisalate, and zinc oxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-670
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42)	ENSULIZOLE	0.4 g  in 30 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	5.4 g  in 30 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	1.8 g  in 30 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	5.6 g  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
TRISILOXANE (UNII: 9G1ZW13R0G)
GLYCERIN (UNII: PDC6A3C0OX)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
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)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)
PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SANGUISORBA OFFICINALIS ROOT (UNII: 4NYV2HT01X)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
GARCINIA MANGOSTANA BARK (UNII: N6A4WY566I)
PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)
TROLAMINE (UNII: 9O3K93S3TK)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
EDETATE DISODIUM (UNII: 7FLD91C86K)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ALCOHOL (UNII: 3K9958V90M)
ISOSTEARIC ACID (UNII: X33R8U0062)
3-((L-MENTHYL)OXY)PROPANE-1,2-DIOL (UNII: KD6TZ2QICH)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
BARIUM SULFATE (UNII: 25BB7EKE2E)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BENZOIC ACID (UNII: 8SKN0B0MIM)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-670-10	1 in 1 CARTON	01/01/2022
1		30 mL in 1 BOTTLE; 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)