FDA.reportPublic FDA data

SHISEIDO URBAN ENVIRONMENT MINERAL CLEAR SUNSCREEN

Manufacturer
Shiseido Americas Corporation | Shiseido America Inc.
Effective date
2026-02-23
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:46:59

Label at a glance#

ProductSHISEIDO URBAN ENVIRONMENT MINERAL CLEAR SUNSCREEN
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure13 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 cause 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 includ...

Storage and handling

protect this productt in this container from excessive heat and direct sun

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - PURPOSE SECTION

Active IngredientsPurpose
Titanium Dioxide 4.5%Sunscreen
Zinc Oxide 17.2% 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 cause by the sun

Warnings

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

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 INGREDIENT SECTION

DIMETHICONE･WATER･DIISOPROPYL SEBACATE･DIPHENYLSILOXY PHENYL TRIMETHICONE･DIPROPYLENE GLYCOL･GLYCERIN･SORBITAN SESQUIISOSTEARATE･POLYHYDROXYSTEARIC ACID･LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE･SILICA･AMINOETHANESULFINIC ACID･THIOTAURINE･SCUTELLARIA BAICALENSIS ROOT EXTRACT･PAEONIA ALBIFLORA ROOT EXTRACT･SODIUM HYALURONATE･DIPOTASSIUM GLYCYRRHIZATE･GINKGO BILOBA LEAF EXTRACT･PEG/PPG-14/7 DIMETHYL ETHER･ONONIS SPINOSA ROOT EXTRACT･CAMELLIA JAPONICA FLOWER EXTRACT･GARCINIA MANGOSTANA BARK EXTRACT･TREHALOSE･SPIRULINA PLATENSIS EXTRACT･SOLUBLE COLLAGEN･ALUMINUM HYDROXIDE･TRIETHOXYCAPRYLYLSILANE･STEARIC ACID･DISTEARDIMONIUM HECTORITE･BUTYLENE GLYCOL･TRISODIUM EDTA･ISOSTEARIC ACID･SODIUM CITRATE･CITRIC ACID･SODIUM METABISULFITE･PRUNUS YEDOENSIS LEAF EXTRACT･SYZYGIUM JAMBOS LEAF EXTRACT･TOCOPHEROL･MICA･DISODIUM PHOSPHATE･RIBOFLAVIN･ERGOTHIONEINE･SODIUM PHOSPHATE･PHENOXYETHANOL･BENZOIC ACID･TITANIUM DIOXIDE･

Other information

STORAGE AND HANDLING SECTION

  • protect this productt in this container from excessive heat and direct sun

Questions or Comments?

OTC - QUESTIONS SECTION

Call toll free 1-800-906-7503

PRINCIPAL DISPLAY PANEL - 30 mL Bottle

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SHISEIDO

Ginza Tokyo

Urban Environment

MINERAL CLEAR

Sunscreen 

SPF 50

Daily Protection & Age Defense

BROAD SPECTRUM SPF 50

WATER RESISTANT (40 MINUTES)

For All Skin Types Including Sensitive

30mL 1 FL. OZ. 

urban environment labelurban environment label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58411-951-10SHISEIDO URBAN ENVIRONMENT MINERAL CLEAR SUNSCREEN1 in 1 BOXLOTION13
58411-951-10SHISEIDO URBAN ENVIRONMENT MINERAL CLEAR SUNSCREEN30 mL in 1 BOTTLE, PLASTICLOTION303

Products#

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

DailyMed product names page 1 of 2 · 47 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58411-95158411-951-10

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 45 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIMETHICONE92RU3N3Y1OIACT
WATER059QF0KO0RIACT
DIISOPROPYL SEBACATEJ8T3X564IHIACT
DIPHENYLSILOXY PHENYL TRIMETHICONEI445L28B12IACT
DIPROPYLENE GLYCOLE107L85C40IACT
GLYCERINPDC6A3C0OXIACT
SORBITAN SESQUIISOSTEARATEVU97D01BF9IACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE25G622K2RAIACT
SILICAETJ7Z6XBU4IACT
AMINOETHANESULFINIC ACID5L08GE4332IACT
THIOTAURINENQZ2D7AO62IACT
SCUTELLARIA BAICALENSIS ROOT7J95K7ID2SIACT
PAEONIA ALBIFLORA FLOWERR73687A534IACT
SODIUM HYALURONATEYSE9PPT4THIACT
DIPOTASSIUM GLYCYRRHIZATECA2Y0FE3FXIACT
GINKGO BILOBA LEAF19FUJ2C58TIACT
PEG/PPG-14/7 DIMETHYL ETHER6DNW9T7YT2IACT
ONONIS SPINOSA ROOTFD2FMC53M1IACT
CAMELLIA JAPONICA FLOWERKUB8101TNFIACT
GARCINIA MANGOSTANA BARKN6A4WY566IIACT
TREHALOSEB8WCK70T7IIACT
SPIRULINA PLATENSIS9L3TIH1UUEIACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
STEARIC ACID4ELV7Z65APIACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
TRISODIUM EDTA420IP921MBIACT
ISOSTEARIC ACIDX33R8U0062IACT
SODIUM CITRATE1Q73Q2JULRIACT
CITRIC ACID2968PHW8QPIACT
SODIUM METABISULFITE4VON5FNS3CIACT
PRUNUS X YEDOENSIS LEAF1Z125GA907IACT
SYZYGIUM JAMBOS LEAF407Z4W5LFFIACT
TOCOPHEROLR0ZB2556P8IACT
MICAV8A1AW0880IACT
DISODIUM PHOSPHATE22ADO53M6FIACT
RIBOFLAVINTLM2976OFRIACT
ERGOTHIONEINEBDZ3DQM98WIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22025-12-16monthly-update2026-06-03 17:46:00

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
SHISEIDO URBAN ENVIRONMENT MINERAL CLEAR SUNSCREENTITANIUM DIOXIDE, ZINC OXIDEShiseido Americas Corporationb93f10dc-193d-4cda-94b6-3f0e54d89f212026-02-23WarningsExact identifier
ndc (package): 58411-951-10
ndc (product): 58411-951
ndc11 (package): 58411095110
spl id: 4b83b4ee-100f-3246-e063-6394a90a2108
spl set id: b93f10dc-193d-4cda-94b6-3f0e54d89f21

Reported adverse events (FAERS/openFDA)#

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