FDA.reportPublic FDA data

SHISEIDO URBAN ENVIRONMENT

Product NDC
58411-952
11-digit product format
584110952
Labeler code
58411
Product ID
58411-952_4617da57-c5ae-99fc-e063-6394a90ac726
Type
HUMAN OTC DRUG
Nonproprietary name
Ensulizole, Homosalate, Octisalate, Zinc OXide
Dosage form
EMULSION
Route
TOPICAL
Labeler
Shiseido Americas Corporation
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-12-11
Substance
ENSULIZOLE; HOMOSALATE; OCTISALATE; ZINC OXIDE
Active strength
.6; 9; 3; 9.3 g/50mL; g/50mL; g/50mL; g/50mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
SHISEIDO URBAN ENVIRONMENT
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ENSULIZOLE.6 g/50mL
HOMOSALATE9 g/50mL
OCTISALATE3 g/50mL
ZINC OXIDE9.3 g/50mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9YQ9DI1W42Internal UNII lookup
V06SV4M95SInternal UNII lookup
4X49Y0596WInternal UNII lookup
SOI2LOH54ZInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8db9f5e0-a8d6-4872-b4c6-cb92c43d25c2Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
5dbf91a8-ec29-4ffc-807c-e3bae7fb67b1Product name120201123
85bed648-23ca-4804-98e6-e36aee999cadProduct name120190717
80de93b4-8a94-428d-beb7-d644353ee70bProduct name120180424
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
eb4f7d5b-1286-40dc-b8bf-ad87ff51c688Product name120170522
db8eb201-78c7-4590-8a71-fac0a539bd8cProduct name120170404
141092be-5eb5-452e-9f69-2d350aa70a87Product name120161208
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58411-952-10SHISEIDO URBAN ENVIRONMENT50 mL in 1 BOTTLE, PLASTICEMULSION502
58411-952-10SHISEIDO URBAN ENVIRONMENT1 in 1 BOXEMULSION12

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 94 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Eucerin Sensitive Mineral Face Sunscreen SPF 35ZINC OXIDE 24%Beiersdorf Incf3a8bb6b-f051-5d39-e053-2a95a90adafc2025-12-31WarningsExact identifier
application number: M020
Coppertone Limited Edition Sunscreen SPF 30AVOBENZONE 2%, HOMOSALATE 8%, OCTISALATE 4.5%, OCTOCRYLENE 7%Beiersdorf Incf41e09bf-407d-65a4-e053-2a95a90a24362025-12-31WarningsExact identifier
application number: M020
Coppertone Glow Hydragel SPF 50AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9%Beiersdort Incb5f7cacb-92b9-a6b7-e053-2a95a90aea022025-12-31WarningsExact identifier
application number: M020
Eucerin Advanced Hydration Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBeiersdorf Inccd6112fe-89e4-a79b-e053-2a95a90ad7f42025-12-31WarningsExact identifier
application number: M020
Eucerin Age Defense SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBeiersdort Inccd9d4f30-fb37-9935-e053-2995a90a99362025-12-31WarningsExact identifier
application number: M020
Coppertone Sport Sunscreen SPF 70AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%, OXYBENZONE 6%Beiersdorf Inccc5d1f9b-2c8a-1392-e053-2a95a90acb9e2025-12-31WarningsExact identifier
application number: M020
Coppertone Every Tone Brightening Sunscreen SPF 60AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Beiersdorf Inc23e368db-4b2f-d23b-e063-6394a90a1f062025-12-31WarningsExact identifier
application number: M020
Eucerin Advanced Hydration Ultra-Light Face Sunscreen SPF 50AVOBENZENE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 10%Beiersdorf Inc25d9c520-431a-5546-e063-6394a90a4e0d2025-12-31WarningsExact identifier
application number: M020
Eucerin Advanced Hydration Sunscreen SPF 30(TO DELIVER) AVOBENZONE 3%, HOMOSALATE 7%, OCTISALATE 4.5%, OCTOCRYLENE 8%Beiersdorf Inc1273012a-107c-1b19-e063-6394a90a53e42025-12-31WarningsExact identifier
application number: M020
Coppertone Every Tone Face Hydrating Clear Sunscreen SPF 60AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Beiersdorf Inc23e5bf2c-88c2-d346-e063-6394a90abc782025-12-31WarningsExact identifier
application number: M020
Coppertone Every Tone Invisible Clear Sunscreen Stick SPF 55AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 10%Beiersdorf Inc23fb728a-8c11-d041-e063-6294a90abb552025-12-31WarningsExact identifier
application number: M020
Coppertone Kids Sport Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 5%Beiersdorf Incc0421c97-72bd-fcac-e053-2995a90aac282025-12-31WarningsExact identifier
application number: M020
Coppertone Defend and ClearOCTINOXATE, OCTISALATE, ZINC OXIDEBeiersdorf Incbaaec6a9-2c60-2d11-e053-2a95a90abca72025-12-31WarningsExact identifier
application number: M020
Coppertone Pure and Simple Sunscreen SPF 50ZINC OXIDE 24.08%Beiersdorf Incb6492438-5dd2-030e-e053-2a95a90a2f9f2025-12-31WarningsExact identifier
application number: M020
Coppertone Sport Sunscreen SPF 30AVOBENZONE 2%, HOMOSALATE 8%, OCTISALATE 4.5%, OCTOCRYLENE 7%Beiersdort Incca8d2e20-c1f1-ecf2-e053-2a95a90a790f2025-12-31WarningsExact identifier
application number: M020
Eucerin Tinted Age Defense Suncreen SPF 50AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 10%Beiersdorf Inc125d053c-9418-5772-e063-6294a90a6d6d2025-12-31WarningsExact identifier
application number: M020
Coppertone Sport SPF 15 SunscreenAVOBENZONE 2%, OCTISALATE 4.5%, OCTOCRYLENE 7%Beiersdorf Inccc4812da-0686-7789-e053-2995a90a561f2025-12-31WarningsExact identifier
application number: M020
Coppertone Sport Mineral Sunscreen SPF 50ZINC OXIDEBeiersdorf Incb6861830-fdad-3829-e053-2a95a90a09712025-12-31WarningsExact identifier
application number: M020
Coppertone Kids Tear Free Mineral Sunscreen SPF 50OCTINOXATE 7.5%, OCTISALATE 5%, ZINC OXIDE 14.5%Beiersdorf Incc054fd86-b0d9-24fc-e053-2a95a90aea2c2025-12-31WarningsExact identifier
application number: M020
Coppertone Kids Sunscreen SPF 70AVOBENZONE 3%, HOMOSALATE 13%, OCTISALATE 5%, OCTOCRYLENE 10%, OXYBENZONE 6%Beiersdorf Incc0552256-d8cb-5473-e053-2995a90ad0d52025-12-31WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
58411-952-105841109521050 mL in 1 BOTTLE, PLASTIC50 mlHistorical