FDA.reportPublic FDA data

SHISEIDO URBAN ENVIRONMENT FRESH-MOISTURE SUNSCREEN SPF 42

Product NDC
58411-671
11-digit product format
584110671
Labeler code
58411
Product ID
58411-671_4a014918-5ec5-c2ee-e063-6394a90ae746
Type
HUMAN OTC DRUG
Nonproprietary name
avobenzone, homosalate, octisalate, and octocrylene
Dosage form
CREAM
Route
TOPICAL
Labeler
SHISEIDO AMERICAS CORPORATION
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-01-01
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength
1.2; 5.2; 2.6; 2.6 g/50mL; g/50mL; g/50mL; g/50mL
NDC exclude flag
No
Listing certified through
2027-12-31
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 FRESH-MOISTURE SUNSCREEN SPF 42
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE1.2 g/50mL
HOMOSALATE5.2 g/50mL
OCTISALATE2.6 g/50mL
OCTOCRYLENE2.6 g/50mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G63QQF2NOXInternal UNII lookup
V06SV4M95SInternal UNII lookup
4X49Y0596WInternal UNII lookup
5A68WGF6WMInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
42adc51f-f500-485d-82a0-126672141262Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58411-671-60SHISEIDO URBAN ENVIRONMENT FRESH-MOISTURE SUNSCREEN SPF 4250 mL in 1 TUBECREAM504
58411-671-60SHISEIDO URBAN ENVIRONMENT FRESH-MOISTURE SUNSCREEN SPF 421 in 1 CARTONCREAM14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58411-671SHISEIDO URBAN ENVIRONMENT FRESH-MOISTURE SUNSCREEN SPF 42 (AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE) CREAM [SHISEIDO AMERICAS CORPORATION]2Current NDC, Legacy NDC, 2 package rows20241225_42adc51f-f500-485d-82a0-126672141262.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 185 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dolce and Gabbana Blueberry Nutri Tint SPF 20 9C Light MediumZINC OXIDEDolce & Gabbana Beauty S.R.L41fd80a9-2c6f-4f3e-a37d-e781965ddc552025-09-05WarningsExact identifier
application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 11W Light MediumZINC OXIDEDolce & Gabbana Beauty S.R.L50bac9fb-5b81-4cdd-9eae-ec9530fc46c32025-09-05WarningsExact identifier
application number: M020
Jack Black L.L.C.AVOBENZONE/HOMOSALATE/OCTISALATE/PETROLATUMJack Black L.L.C.3e0eb291-6bda-2f26-e063-6294a90ac4662025-09-05WarningsExact identifier
application number: M020
Jack BlackAVOBENZONE/HOMOSALATE/OCTISALATE/PETROLATUMJack Black L.L.C.3d5fafb9-62c9-ec69-e063-6394a90af8b92025-09-05WarningsExact identifier
application number: M020
Jack BlackAVOBENZONE/HOMOSALATE/OCTISALATE/PETROLATUMJack Black L.L.C.3e0f655e-6100-f1dd-e063-6394a90af7b72025-09-05WarningsExact identifier
application number: M020
Truskin SPF 30 Mineral Sunscreen Facial SerumZINC OXIDEAllure Labs3e13299f-8d5d-373b-e063-6394a90ab2562025-09-05WarningsExact identifier
application number: M020
PowderTITANIUM DIOXIDEOxygen Development LLC08b52f29-c1a0-c673-e063-6294a90a9a7a2025-09-05WarningsExact identifier
application number: M020
PowderTITANIUM DIOXIDEOxygen Development LLC08b8003f-40be-3380-e063-6294a90a4f6b2025-09-05WarningsExact identifier
application number: M020
MAYDAY Everyday Sunscreen SPF 30ZINC OXIDEOmniche Consumer Products Co.3f53fb40-6347-46b0-979c-3522d99481982025-09-04WarningsExact identifier
application number: M020
PHOFAY Matte Sunscreen Liquid Foundation SPF 30, 1ENSULIZOLE, HOMOSALATE, OCTINOXATE, TITANIUM DIOXIDEHangzhou Jingshen Trading Co., Ltd.18130858-429c-4ed4-a75b-5bc0144812502025-09-04WarningsExact identifier
application number: M020
Introstem PrismaStem Face Shield CreamOCTINOXATE, HOMOSALATE, OCTISALATE, OXYBENZONE AND AVOBENZONEInnovation Brands Inc.dd91374a-e3fc-42f1-a660-86b32a0cc8b82025-09-04WarningsExact identifier
application number: M020
MEDICUBE COLLAGEN GLOW SUNSCREENHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEAPR US INC34fae072-536c-ad41-e063-6394a90af0af2025-09-03WarningsExact identifier
application number: M020
Basin Sugar Plum SPF 15 Broad Spectrum Sunscreen Lip BalmAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENERetail Concepts of Minnesota, Inc.3de75cec-955e-4b3a-e063-6394a90a15432025-09-03WarningsExact identifier
application number: M020
Basin Mint SPF 30 Broad Spectrum Sunscreen Lip Balm SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONERetail Concepts of Minnesota, Inc.3de7d21b-4f88-d80c-e063-6394a90a8e4c2025-09-03WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 38C DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L0358a87d-8002-4f3e-851a-3a582d356edf2025-09-03WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 39N DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L34dfc4c5-44f7-4531-97ba-8846ebe147242025-09-03WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 40C DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.Lcf4b6f45-d4ae-4665-87b4-c5af4910befa2025-09-03WarningsExact identifier
application number: M020
DOLCE and GABBANA MEET YOUR FLAWLESS MATTE SKIN DUO - EVERLAST PRIMER EVERLAST FOUNDATIONOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDOLCE & GABBANA BEAUTY SRLeb63e9c6-bdb0-4bdf-8822-e4561a56adc92025-09-03WarningsExact identifier
application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 1N LightZINC OXIDEDolce & Gabbana Beauty S.R.L9507681c-236c-41c1-9dc9-ed4c0c0917412025-09-03WarningsExact identifier
application number: M020
Pure6 ManiShield Hand ScreenZINC OXIDE, TITANIUM DIOXIDEGUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD3abcb6ba-1de8-55e7-e063-6294a90aecf12025-09-02WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58411-671-60584110671601 TUBE in 1 CARTON (58411-671-60) / 50 mL in 1 TUBE1 tube2022-01-010000-00-00NoNoCurrent