SHISEIDO URBAN ENVIRONMENT OIL-FREE UV PROTECTOR- zinc oxide, homosalate, octocrylene, and octisalate emulsion

SHISEIDO URBAN ENVIRONMENT oil-FREE UV PROTECTOR by

Drug Labeling and Warnings

SHISEIDO URBAN ENVIRONMENT oil-FREE UV PROTECTOR 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
HOMOSALATE 5.0%	Sunscreen
OCTISALATE 5.0%	Sunscreen
OCTOCRYLENE 5.0%	Sunscreen
ZINC OXIDE 9.7%	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 two 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
  • wear long-sleeve shirts, pants, hats, and sunglasses
  • children under 6 months: Ask a doctor

Inactive Ingredients

WATER∙ISODODECANE∙DIMETHICONE∙SD ALCOHOL 40-B∙DIPROPYLENE GLYCOL∙ETHYLHEXYL PALMITATE∙PEG-10 DIMETHICONE∙GLYCERIN∙POLYMETHYLSILSESQUIOXANE∙VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER∙POLYBUTYLENE GLYCOL/PPG-9/1 COPOLYMER∙XYLITOL∙SILICA∙METHYL METHACRYLATE CROSSPOLYMER∙THIOTAURINE∙SCUTELLARIA BAICALENSIS ROOT EXTRACT∙PAEONIA ALBIFLORA ROOT EXTRACT∙ONONIS SPINOSA ROOT EXTRACT∙ECTOIN∙LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE∙HYDROGEN DIMETHICONE∙BUTYLENE GLYCOL∙DISODIUM EDTA∙DISTEARDIMONIUM HECTORITE∙TOCOPHEROL∙ALUMINUM HYDROXIDE∙TRIETHOXYCAPRYLYLSILANE∙SODIUM METABISULFITE∙SYZYGIUM JAMBOS LEAF EXTRACT∙PHENOXYETHANOL∙BENZOIC ACID∙FRAGRANCE∙TITANIUM DIOXIDE∙MICA∙

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 - 50 mL Bottle Carton

SHISEIDO
GINZA TOKYO

Urban Environment
Oil-Free UV Protector

42

BROAD SPECTRUM
SPF 42

For Face

WATER RESISTANT
(40 MINUTES)

SUNSCREEN

50mL 1.6 FL. OZ.

INGREDIENTS AND APPEARANCE

SHISEIDO URBAN ENVIRONMENT OIL-FREE UV PROTECTOR 
zinc oxide, homosalate, octocrylene, and octisalate emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-627
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	5.16 g  in 50 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	2.65 g  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2.65 g  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	2.65 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ISODODECANE (UNII: A8289P68Y2)
DIMETHICONE (UNII: 92RU3N3Y1O)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
GLYCERIN (UNII: PDC6A3C0OX)
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
XYLITOL (UNII: VCQ006KQ1E)
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
EDETATE DISODIUM (UNII: 7FLD91C86K)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
THIOTAURINE (UNII: NQZ2D7AO62)
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)
MICA (UNII: V8A1AW0880)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)
ECTOINE (UNII: 7GXZ3858RY)
SYZYGIUM JAMBOS LEAF (UNII: 407Z4W5LFF)
ONONIS SPINOSA ROOT (UNII: FD2FMC53M1)
BENZOIC ACID (UNII: 8SKN0B0MIM)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-627-60	1 in 1 CARTON	01/01/2021
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 58411-627-61	1 in 1 CARTON	01/01/2021
2		30 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 FINAL	part352	01/01/2021

Labeler - SHISEIDO AMERICAS CORPORATION (193691821)