FDA.reportPublic FDA data

SHISEIDO URBAN ENVIRONMENT Oil-Free SUNSCREEN SPF 42

Product NDC
58411-670
11-digit product format
584110670
Labeler code
58411
Product ID
58411-670_c3672661-2ff1-4696-917c-47ac9136f7fe
Type
HUMAN OTC DRUG
Nonproprietary name
ensulizole, homosalate, octisalate, and zinc oxide
Dosage form
EMULSION
Route
TOPICAL
Labeler
SHISEIDO AMERICAS CORPORATION
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-01-01
Substance
ENSULIZOLE; HOMOSALATE; OCTISALATE; ZINC OXIDE
Active strength
.4; 5.4; 1.8; 5.6 g/30mL; g/30mL; g/30mL; g/30mL
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 Oil-Free SUNSCREEN SPF 42
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ENSULIZOLE.4 g/30mL
HOMOSALATE5.4 g/30mL
OCTISALATE1.8 g/30mL
ZINC OXIDE5.6 g/30mL

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
21bde283-a554-45c8-8733-2a8adeff41b1Available 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58411-670-10SHISEIDO URBAN ENVIRONMENT Oil-Free SUNSCREEN SPF 4230 mL in 1 BOTTLEEMULSION304
58411-670-10SHISEIDO URBAN ENVIRONMENT Oil-Free SUNSCREEN SPF 421 in 1 CARTONEMULSION14
58411-670-11SHISEIDO URBAN ENVIRONMENT Oil-Free SUNSCREEN SPF 4250 mL in 1 BOTTLEEMULSION504
58411-670-11SHISEIDO URBAN ENVIRONMENT Oil-Free SUNSCREEN SPF 421 in 1 CARTONEMULSION14
58411-670-12SHISEIDO URBAN ENVIRONMENT Oil-Free SUNSCREEN SPF 42143 mL in 1 BOTTLEEMULSION1434
58411-670-12SHISEIDO URBAN ENVIRONMENT Oil-Free SUNSCREEN SPF 421 in 1 CARTONEMULSION14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58411-670SHISEIDO URBAN ENVIRONMENT OIL-FREE SUNSCREEN SPF 42 (ENSULIZOLE, HOMOSALATE, OCTISALATE, AND ZINC OXIDE) EMULSION [SHISEIDO AMERICAS CORPORATION]4Current NDC, Legacy NDC, 6 package rows20250322_21bde283-a554-45c8-8733-2a8adeff41b1.zip

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 8 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ceile tint PROTECT tinted serum SPF 50 IvoryCEILE TINT PROTECT TINTED SERUM SPF 50 IVORYLE COSMETICS INC58547809-3480-1032-e063-6294a90a04c62026-08-05WarningsExact identifier
application number: M020
Ceile tint PROTECT tinted serum SPF 50 Medium DeepCEILE TINT PROTECT TINTED SERUM SPF 50 MEDIUM DEEPLE COSMETICS INC58549160-3594-9056-e063-6394a90abf7d2026-08-05WarningsExact identifier
application number: M020
Ceile tint PROTECT tinted serum SPF 50 DeepCEILE TINT PROTECT TINTED SERUM SPF 50 DEEPLE COSMETICS INC585498d4-b29c-9580-e063-6394a90adf1e2026-08-05WarningsExact identifier
application number: M020
Ceile tint PROTECT tinted serum SPF 50 FairCEILE TINT PROTECT TINTED SERUM SPF 50 FAIRLE COSMETICS INC58545633-cb36-6611-e063-6394a90a1f072026-08-05WarningsExact identifier
application number: M020
Ceile tint PROTECT tinted serum SPF 50 LightCEILE TINT PROTECT TINTED SERUM SPF 50 LIGHTLE COSMETICS INC5853ae6b-0eaf-e614-e063-6394a90ae91a2026-08-05WarningsExact identifier
application number: M020
Ceile tint PROTECT tinted serum SPF 50 Light MediumCEILE TINT PROTECT TINTED SERUM SPF 50 LIGHT MEDIUMLE COSMETICS INC585473c3-3ee9-7d84-e063-6394a90abd332026-08-05WarningsExact identifier
application number: M020
Ceile tint PROTECT tinted serum SPF 50 MediumCEILE TINT PROTECT TINTED SERUM SPF 50 MEDIUMLE COSMETICS INC58547b48-251a-10eb-e063-6294a90ac95c2026-08-05WarningsExact identifier
application number: M020
Ceile tint PROTECT tinted serum SPF 50 Medium TanCEILE TINT PROTECT TINTED SERUM SPF 50 MEDIUM TANLE COSMETICS INC58547e38-ae84-82ee-e063-6394a90a27d62026-08-05WarningsExact identifier
application number: M020
Ceile tint PROTECT tinted serum SPF 50 TanCEILE TINT PROTECT TINTED SERUM SPF 50 TANLE COSMETICS INC58548331-38cd-8668-e063-6394a90a33622026-08-05WarningsExact identifier
application number: M020
Ceile tint PROTECT tinted serum SPF 50 Medium HoneyCEILE TINT PROTECT TINTED SERUM SPF 50 MEDIUM HONEYLE COSMETICS INC5854861a-376d-8825-e063-6394a90a8aab2026-08-05WarningsExact identifier
application number: M020
Ceile tint PROTECT tinted serum SPF 50 HoneyCEILE TINT PROTECT TINTED SERUM SPF 50 HONEYLE COSMETICS INC585488c5-fac5-212f-e063-6294a90a00ff2026-08-05WarningsExact identifier
application number: M020
Ceile tint PROTECT tinted serum SPF 50 Medium RichCEILE TINT PROTECT TINTED SERUM SPF 50 MEDIUM RICHLE COSMETICS INC585488af-d14f-8d71-e063-6394a90ac4f02026-08-05WarningsExact identifier
application number: M020
Ceile tint PROTECT tinted serum SPF 50 RichCEILE TINT PROTECT TINTED SERUM SPF 50 RICHLE COSMETICS INC58548e6d-9c82-249c-e063-6294a90a11ad2026-08-05WarningsExact identifier
application number: M020
12 Days of Derm-Loved SkincareOCTINOXATE, ZINC OXIDE, OATMEAL, BENZOYL PEROXIDE, AVOBENZONE, OCTISALATE, OCTOCRYLENERodan & Fieldsa13f0275-5add-4464-88d4-ff98232743252026-08-03WarningsExact identifier
application number: M020
Luxe Gloss Hydrating Lip Gloss SPF 35-NAKED HONEYOCTOCRYLENE 8%, OCTISALATE 5%, TITANIUM DIOXIDE 6%, ZINC OXIDE 8%Lale Cosmetics LLC581fb0cd-c55d-d562-e063-6394a90a7f112026-08-03WarningsExact identifier
application number: M020
Manyo Air Light Moisturizing Sunscreen SPF 50ENSULIZOLE, HOMOSALATE, OCTISALATE, OCTOCRYLENEManyo Factory Corp.86761577-a32c-41a2-a2e3-b339b14937012026-08-03WarningsExact identifier
application number: M020
EltaMD UV ActiveZINC OXIDE AND TITANIUM DIOXIDE SUNSCREENCP Skin Health Group, Inc39d16479-d491-4c19-aa11-674461687c7b2026-08-03WarningsExact identifier
application number: M020
AMBI SKINCARE Even and Clear Daily Facial Moisturizer SPF 30OCTISALATE, OCTOCRYLENE, AVOBENZONEAMBI Enterprises LLC99bbe9a2-bb57-4a33-b339-1649d4b319c82026-07-31WarningsExact identifier
application number: M020
AMBI Even and Clear Facial Moisturizer SPF-30AVOBENZONE, OCTISALATE, OCTOCRYLENEAMBI Enterprises LLC4701c0ba-4ceb-4d66-9f99-515ce33b46482026-07-31WarningsExact identifier
application number: M020
Continuous Correction CreamTITANIUM DIOXIDEBaxter of California, LLC1cbcc648-f2e1-af60-e063-6294a90ad4bb2026-07-31WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58411-670-10584110670101 BOTTLE in 1 CARTON (58411-670-10) / 30 mL in 1 BOTTLE1 bottle2022-01-010000-00-00NoNoCurrent
58411-670-11584110670111 BOTTLE in 1 CARTON (58411-670-11) / 50 mL in 1 BOTTLE1 bottle2022-01-01NoNoCurrent
58411-670-12584110670121 BOTTLE in 1 CARTON (58411-670-12) / 143 mL in 1 BOTTLE1 bottle2022-01-01NoNoCurrent