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 79 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 4W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior58efeaaf-d3c6-44e9-b60f-8f22f5bb1d332026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 4WP Warm PeachOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorf6b4a90b-5905-4f62-9e35-f2b1dda8dddd2026-01-16WarningsExact identifier
application number: M020
Poolside Frostbite Sunscreen Watermelon SPF 15 Scented Lip GlossHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEI World LLC42c8fd50-73c6-480b-9d7e-31157e5869292026-01-16WarningsExact identifier
application number: M020
HYDRA VIZOR HUEZ TINTED MOISTURIZER BROAD SPECTRUM SPF 30ZINC OXIDEKENDO HOLDINGS INC.18fb7472-746f-339a-e063-6294a90a267d2026-01-16WarningsExact identifier
application number: M020
THE ENERGIST Multi-Defense Broad Spectrum Sunscreen SPF 50ZINC OXIDENoble Panacea Labs, Inc.aed57f81-4b7d-42dc-993e-6bb10f93b02a2026-01-16WarningsExact identifier
application number: M020
BRUSH and GO SPF 50 ALL SKIN TYPES BROAD SPECTRUMTITANIUM DIOXIDE, OCTINOXATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE, AND OXYBENZONENoon Aesthetics M.R. Ltd0d9f132c-7630-4261-a0f8-fc7a4377731f2026-01-16WarningsExact identifier
application number: M020
BRUSH and GO SPF 50 OILY/PROBLEMATIC SKIN BROAD SPECTRUMTITANIUM DIOXIDE, OCTINOXATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE, AND OXYBENZONENoon Aesthetics M.R. Ltdf292da7d-ffd2-41c3-9a64-619aab19ff182026-01-15WarningsExact identifier
application number: M020
Multivit Sun ProtectorTITANIUM DIOXIDE, OCTOCRYLENE, AND AVOBENZONENoon Aesthetics M.R. Ltdabdb560d-29be-41dc-ad23-54ea571acb142026-01-15WarningsExact identifier
application number: M020
BeautyBarrierZINC OXIDENAKED SUNDAYS PTY LTD45740afa-230d-4dd5-e063-6394a90a102f2026-01-15WarningsExact identifier
application number: M020
Glow This WayOCTISALATE, OCTOCRYLENE, ZINC OXIDE, AVOBENZONE, HOMOSALATEKoco Life LLC4619cf96-987a-3e88-e063-6294a90afbe92026-01-15WarningsExact identifier
application number: M020
Reef safe lip balm 01AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.486930f2-026b-14b4-e063-6394a90aa0312026-01-15WarningsExact identifier
application number: M020
DRAMATICALLY DIFFERENT MOISTURIZING LTN BROAD SPECTRUM SPF35AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENECLINIQUE LABORATORIES LLC316bf6f8-7d30-2560-e063-6294a90afb8a2026-01-15WarningsExact identifier
application number: M020
Wellcare Sunstick Lip BalmAVOBENZONE, OCTINOXATE, OCTOCRYLENE, OCTISALATEBAMKO, LLCef977575-7ef0-fc09-e053-2a95a90a89932026-01-15WarningsExact identifier
application number: M020
Bali Body Sheer Glow Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBali Body Pty Ltd4872793c-a7c0-1b65-e063-6394a90a8b3a2026-01-15WarningsExact identifier
application number: M020
Getaway Glow SPF 30 Radiant Sunscreen Broad Spectrum SPF 30 SunscreenZINC OXIDEVolition Beauty2631de4b-66e3-0547-e063-6394a90a822c2026-01-15WarningsExact identifier
application number: M020
AGE RESET Restore Plus Protect Day Cream Broad Spectrum SPF 30ZINC OXIDESKINN COSMETICS, LLC350ed168-ab3b-f314-e063-6394a90a8bbf2026-01-15WarningsExact identifier
application number: M020
StriVectin TL Advanced Tightening Neck and Chest Broad Spectrum SPF 35 SunscreenOCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONEStriVectin Operating Company, Inc.4873a262-a19b-555e-e063-6394a90a182a2026-01-15WarningsExact identifier
application number: M020
PINK BEACH SUNSCREEN BODY BROAD SPECTRUM SPF 50SUNSCREENThe Center Brands, LLCe843bb6b-257f-4425-95bc-41774e032a092026-01-15WarningsExact identifier
application number: M020
SANTAL BLOOM SUNSCREEN BODY BROAD SPECTRUM SPF 50SUNSCREENThe Center Brands, LLC1e18f1dd-a4e4-455a-9699-5634b95596782026-01-15WarningsExact identifier
application number: M020
First Aid Beauty Ultra Repair Hydrating Sunscreen Milk Broad Spectrum SPF 45AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEThe Procter & Gamble Manufacturing Company485c345f-0928-fa1a-e063-6294a90aa8562026-01-14WarningsExact 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