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 84 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Play Lip Balm with Acai Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESupergoop, LLC9f5b54c7-a424-6917-e053-2a95a90ac6272026-01-09WarningsExact identifier
application number: M020
Everyday Sunscreen with Sunflower Extract Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATESupergoop, LLC81b9fda2-bd55-1b90-e053-2991aa0a765a2026-01-09WarningsExact identifier
application number: M020
Play Lip Balm Broad Spectrum SPF 30 with MintAVOBENZONE, HOMOSALATE, OCTISALATE,Supergoop, LLC9f6cd243-ef5c-df8a-e053-2a95a90a4e362026-01-09WarningsExact identifier
application number: M020
Poolside Sun Silk Body Sunglow 05 Fragrance SPF 30 Sunscreen BodyHOMOSALATE, OCTOCRYLENE, OCTISALATE, OCTINOXATE, AVOBENZONEI World LLC4416ad39-a4b5-4238-9792-c7f475d1e5612026-01-09WarningsExact identifier
application number: M020
Lip Screen Broad Spectrum SPF 40AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESupergoop, LLCa3e5819a-5132-9760-e053-2a95a90a058b2026-01-09WarningsExact identifier
application number: M020
Poolside Orange Creme SPF 30 Scented SunscreenHOMOSALATE, OCTOCRYLENE, OCTISALATE, OCTINOXATE, AVOBENZONEI World LLCd96a1390-27be-452a-818b-0ba6127e9f962026-01-09WarningsExact identifier
application number: M020
Sugargirl Glowy SPF 30 Face Screen Daybreak Shimmer Sunscreen For the FaceHOMOSALATE, OCTOCRYLENE, OCTISALATE, OCTINOXATE, AVOBENZONEI World LLC4554d9a8-33a1-4299-8a57-dab72980b2eb2026-01-09WarningsExact identifier
application number: M020
Sugargirl Glowy SPF 30 Face Screen Solar Shimmer Sunscreen For the FaceHOMOSALATE, OCTOCRYLENE, OCTISALATE, OCTINOXATE, AVOBENZONEI World LLCb5be8ea7-3408-4495-9a50-3328f76987382026-01-09WarningsExact identifier
application number: M020
Sugargirl Glowy SPF 30 Face Screen Sunlight Shimmer Sunscreen For the FaceHOMOSALATE, OCTOCRYLENE, OCTISALATE, OCTINOXATE, AVOBENZONEI World LLCc99464d1-a5bb-4140-a95e-25d6b383616c2026-01-09WarningsExact identifier
application number: M020
Sugargirl Set Screen SPF 30 Setting Powder Sunscreen LightZINC OXIDE, TITANIUM DIOXIDEI World LLC1fabd546-55e5-4ab2-8a1b-7b161bfbb8662026-01-09WarningsExact identifier
application number: M020
Sugargirl Set Screen SPF 30 Setting Sunscreen MediumZINC OXIDE, TITANIUM DIOXIDEI World LLC876a6f88-8dac-4303-8acb-525999c935282026-01-09WarningsExact identifier
application number: M020
Sugargirl Glowy Face Screen Sunbeam Shimmer Sunscreen For the Face SPF 30HOMOSALATE, OCTOCRYLENE, OCTINOXATE, OCTISALATE, AVOBENZONEI World LLCf6316c4f-076a-4ba5-a526-0e20e5156ced2026-01-09WarningsExact identifier
application number: M020
Sugargirl Set Screen SPF 30 Setting Sunscreen TranslucentZINC OXIDE, TITANIUM DIOXIDEI World LLC0a3bae73-141b-4a47-be35-c5708dfb11802026-01-09WarningsExact identifier
application number: M020
Artistry Exact Fit Longwearing Foundation Shade Sand L2W1TITANIUM DIOXIDEAmway Corp4345cdf6-e220-4e7c-8abd-da59d2b7db842026-01-09WarningsExact identifier
application number: M020
Mineral Sheer Screen Broad Spectrum Sunscreen SPF 30ZINC OXIDESupergoop LLCb47ed3bf-92a8-9bc9-e053-2a95a90a8eee2026-01-09WarningsExact identifier
application number: M020
Daily Dose Hydra-Ceramide Boost Broad Spectrum Sunscreen SPF 40AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESupergoop, LLCca5520a1-4c43-cb32-e053-2a95a90a97f52026-01-09WarningsExact identifier
application number: M020
100% Mineral Broad Spectrum Sunscreen SPF 50TITANIUM DIOXIDE, ZINC OXIDESupergoop LLCd6fcc065-cbcd-0b81-e053-2a95a90ab1f92026-01-09WarningsExact identifier
application number: M020
Glow Screen Body Broad Spectrum Sunscreen SPF 40AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESupergoop, LLCb9590938-417d-617a-e053-2995a90a74962026-01-09WarningsExact identifier
application number: M020
100% Mineral Broad Spectrum Sunscreen SPF 30TITANIUM DIOXIDE, ZINC OXIDESupergoop LLCd7758651-c152-5868-e053-2a95a90ab6732026-01-09WarningsExact identifier
application number: M020
Mineral Sunscreen SPF 30ZINC OXIDESupergoop, LLC4cf243b4-d794-401a-b209-18c7e550ef4f2026-01-09WarningsExact 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