SHISEIDO URBAN ENVIRONMENT OIL-FREE MINERAL SUNSCREEN SPF 42- titanium dioxide and zinc oxide emulsion

SHISEIDO URBAN ENVIRONMENT oil-free MINERAL SUNSCREEN SPF 42 by

Drug Labeling and Warnings

SHISEIDO URBAN ENVIRONMENT oil-free MINERAL SUNSCREEN SPF 42 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

ACTIVE INGREDIENT

Active ingredients	Purpose
TITANIUM DIOXIDE 4.9%	Sunscreen
ZINC OXIDE 13.6%	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
• 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

DIMETHICONE WATER SILICA ZINC OXIDE DIPROPYLENE GLYCOL GLYCERIN CAPRYLYL METHICONE DIPHENYLSILOXY PHENYL TRIMETHICONE ISODODECANE HYDROGENATED POLYDECENE PEG/PPG-14/7 DIMETHYL ETHER PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE BIS-BUTYLDIMETHICONE POLYGLYCERYL-3 PEG-10 DIMETHICONE TREHALOSE PHYTOSTERYL MACADAMIATE ASCORBYL TETRAISOPALMITATE THIOTAURINE DIPOTASSIUM GLYCYRRHIZATE SCUTELLARIA BAICALENSIS ROOT EXTRACT PAEONIA ALBIFLORA ROOT EXTRACT SODIUM HYALURONATE SANGUISORBA OFFICINALIS ROOT EXTRACT CAMELLIA SINENSIS LEAF EXTRACT ONONIS SPINOSA ROOT EXTRACT GARCINIA MANGOSTANA BARK EXTRACT CURCUMA LONGA (TURMERIC) RHIZOME EXTRACT PERILLA OCYMOIDES LEAF EXTRACT SPIRULINA PLATENSIS EXTRACT ALUMINUM HYDROXIDE HYDROGEN DIMETHICONE TRIETHOXYCAPRYLYLSILANE BUTYLENE GLYCOL ISOSTEARIC ACID DISTEARDIMONIUM HECTORITE TRISODIUM EDTA SODIUM CITRATE ALCOHOL CITRIC ACID SODIUM METABISULFITE POLYSILICONE-2 BARIUM SULFATE SYZYGIUM JAMBOS LEAF EXTRACT TOCOPHEROL PHENOXYETHANOL BENZOIC ACID 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
MINERAL
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 MINERAL SUNSCREEN SPF 42 
titanium dioxide and zinc oxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-672
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.8 g  in 30 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	5 g  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
WATER (UNII: 059QF0KO0R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
GLYCERIN (UNII: PDC6A3C0OX)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
ISODODECANE (UNII: A8289P68Y2)
HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
TREHALOSE (UNII: B8WCK70T7I)
PHYTOSTERYL MACADAMIATE (UNII: 233VSF903M)
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)
ONONIS SPINOSA ROOT (UNII: FD2FMC53M1)
GARCINIA MANGOSTANA BARK (UNII: N6A4WY566I)
TURMERIC (UNII: 856YO1Z64F)
PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ISOSTEARIC ACID (UNII: X33R8U0062)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
EDETATE TRISODIUM (UNII: 420IP921MB)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
ALCOHOL (UNII: 3K9958V90M)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
BARIUM SULFATE (UNII: 25BB7EKE2E)
SYZYGIUM JAMBOS LEAF (UNII: 407Z4W5LFF)
TOCOPHEROL (UNII: R0ZB2556P8)
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: 58411-672-10	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)

Establishment
Name	Address	ID/FEI	Business Operations
Shiseido America Inc.		782677132	ANALYSIS(58411-672) , MANUFACTURE(58411-672)