SHISEIDO URBAN ENVIRONMENT OIL-FREE UV PROTECTOR CREAM

Manufacturer
SHISEIDO AMERICA INC.
Effective date
2019-12-26
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:47:59

Label at a glance#

ProductSHISEIDO URBAN ENVIRONMENT oil-FREE UV PROTECTOR
Active ingredientOCTINOXATE, OCTOCRYLENE, ZINC OXIDE
Label structure10 sections

Indications and 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

Dosage and administration

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: lim...

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

ACTIVE INGREDIENTS:Purpose
OCTINOXATE 4.9%Sunscreen
OCTOCRYLENE 3.0%Sunscreen
ZINC OXIDE 12.5%Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

OTC - DO NOT USE SECTION

For external use only

Do not use on damaged or broken skin

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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

INACTIVE INGREDIENT SECTION

WATER, DIMETHICONE, ISODODECANE, SD ALCOHOL 40-B, DIPROPYLENE GLYCOL, ETHYLHEXYL PALMITATE, PEG-10 DIMETHICONE, GLYCERIN, POLYMETHYLSILSESQUIOXANE, VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER, POLYBUTYLENE GLYCOL/PPG-9/1 COPOLYMER, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, XYLITOL, 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, ALUMINA, BHT, TRIETHOXYCAPRYLYLSILANE, SYZYGIUM JAMBOS LEAF EXTRACT, TOCOPHEROL, PHENOXYETHANOL, BENZOIC ACID, FRAGRANCE, TITANIUM DIOXIDE, MICA,

Other information

STORAGE AND HANDLING SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 1-800-906-7503

SPL UNCLASSIFIED SECTION

SHISEIDO AMERICA INC. NEW YORK, N.Y. 10022
SHISEIDO DIST. NEW YORK • PARIS • MILANO

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SHISEIDO
GINZA TOKYO

Urban Environment
Oil-Free UV Protector

42

BROAD SPECTRUM
SPF 42

For Face

WATER RESISTANT
(40 MINUTES)

SUNSCREEN

30mL 1 FL. OZ.

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton
PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58411-34658411-346-10, 58411-346-80, 58411-346-11

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
47aab460-80a7-d4d5-e063-6294a90a726f60cb73cf-81b2-42eb-ad1a-4b2423b640e62026-01-05WarningsExact identifier
spl set id: 60cb73cf-81b2-42eb-ad1a-4b2423b640e6

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.