FDA.reportPublic FDA data

SHISEIDO URBAN ENVIRONMENT FRESH-MOISTURE SUNSCREEN

Product NDC
58411-970
11-digit product format
584110970
Labeler code
58411
Product ID
58411-970_49a1ca55-4396-ace3-e063-6394a90ad478
Type
HUMAN OTC DRUG
Nonproprietary name
AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Dosage form
CREAM
Route
TOPICAL
Labeler
Shiseido Americas Corporation
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-02-01
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength
1.1845; 5.15; 2.575; 2.575 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
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE1.1845 g/50mL
HOMOSALATE5.15 g/50mL
OCTISALATE2.575 g/50mL
OCTOCRYLENE2.575 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
bf16e8b5-b717-4255-a7da-9abe3d1ad8b4Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58411-970-60SHISEIDO URBAN ENVIRONMENT FRESH-MOISTURE SUNSCREEN50 mL in 1 TUBECREAM502
58411-970-60SHISEIDO URBAN ENVIRONMENT FRESH-MOISTURE SUNSCREEN1 in 1 BOXCREAM12

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 66 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Zealios Mineral SPF 30 SunscreenZINC OXIDEPersonal Best Products Inc. dba Zealiosc421b00c-6536-4455-81f6-01686f8c23882026-02-03WarningsExact identifier
application number: M020
Zealios Sport Performance Ultralight SPF 50 SunscreenHOMOSALATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONEPersonal Best Products Inc. dba Zealios020bd1b4-da50-4117-a4f3-b74aa41873962026-02-03WarningsExact identifier
application number: M020
Adrien Arpel Daily Defense Moisturizer SPF 30AVOBENZONE, OCTISALATE, OCTOCRYLENEColor Me Beautiful Incf65e1428-b79a-4126-862a-907ca17ee8f72026-02-02WarningsExact identifier
application number: M020
Flori Roberts Daily Defense Moisturizer SPF 30AVOBENZONE, OCTISALATE, OCTOCRYLENEColor Me Beautiful Inc934d6b80-0cc3-4dcd-a25d-2191bd2736182026-02-02WarningsExact identifier
application number: M020
Dr.Oracle AIR FIT DEFENSE SOOTHING SUNSCREENHOMOSALATE, OCTYL SALICYLATE, TITANIUM DIOXIDE, ZINC OXIDEOracle Cosmetic Co., Ltd.21424f78-f8d5-6a9b-e063-6294a90ab7dc2026-02-02WarningsExact identifier
application number: M020
HAMPTON SUN SPF50 SUNSHIELD BODY GLOWHOMOSALATE 10% OCTOCRYLENE 10% AVOBENZONE 3% OCTICALATE 5%S&C Hampton Sun LLC26190992-9463-47ae-86a5-0dbc05be87732026-02-02WarningsExact identifier
application number: M020
SunscreenAVOBENZONE, HOMOSALATE,OTISALATE, OCTOCRYLENERite Aid Corporationfe9146ec-b85d-43da-a391-377960f2c7722026-02-02Warnings, Adverse reactionsExact identifier
application number: M020
sheerAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENERite Aid Corporation299a6690-9746-4410-a625-7636f0b4a7542026-02-02Warnings, Adverse reactionsExact identifier
application number: M020
Dr. C. Tuna Sun Stick SPF 50AVOBENZONE, OCTINOXATE, HOMOSALATE, OCTOCRYLENEFarmasi US LLC49dc6040-b400-7f5b-e063-6394a90ac7d72026-02-02WarningsExact identifier
application number: M020
Naturium Dew Glow Moisturizer Mineral SPF 50ZINC OXIDEe.l.f. Cosmetics, Inc535f798f-d21d-92b2-e063-6294a90a72c72026-02-02WarningsExact identifier
application number: M020
Sol de Janiero Rio Radiance SPF 50 BodyZINC OXIDECosmetic Solutions LLC2d54727d-5dcc-4792-85e8-1a2f21fe9e3d2026-02-02WarningsExact identifier
application number: M020
Sky and Sol Face and Body Sunscreen Spf 50ZINC OXIDEDelta Ecommerce LLC47d9dc66-328f-4cab-e063-6394a90a279d2026-02-01WarningsExact identifier
application number: M020
e.l.f. Suntouchable Invisi-Stick Glitz SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f cosmetics,Inc.4b801bb3-8930-7e04-e063-6294a90adaa12026-02-01WarningsExact identifier
application number: M020
SHISEIDO ULTIMATE SUN PROTECTOR CLEARAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEShiseido Americas Corporationcedd7a3e-3334-437f-a283-482bcd0064ee2026-01-30WarningsExact identifier
application number: M020
SHISEIDO URBAN ENVIRONMENT FRESH-MOISTURE SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEShiseido Americas Corporationbf16e8b5-b717-4255-a7da-9abe3d1ad8b42026-01-30WarningsExact identifier
application number: M020
ndc (product): 58411-970
SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENERite Aid Corporation372a8fba-b190-40fe-a1fc-fecf7f7afc352026-01-30Warnings, Adverse reactionsExact identifier
application number: M020
ALOE UP MEDICATED LIP BALM SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONEAloe Care International, LLC859b6d3f-b1ca-4966-8f0c-f9afa0d5864c2026-01-30WarningsExact identifier
application number: M020
ALOE UP SPORT NATURAL BALM SPF-15AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENEAloe Care International, LLC3de029ed-97f7-4cb3-a32e-d412bf3b58742026-01-30WarningsExact identifier
application number: M020
Reef safe unscented SPF 50 mineral sunscreen 01TITANIUM DIOXIDE, ZINC OXIDECosmuses Cosmetics (Ningbo) Co., Ltd.49a77ad4-508c-9617-e063-6394a90a56232026-01-30WarningsExact identifier
application number: M020
JOSIE MARAN ARGAN SUN MILK MINERAL SUNSCREEN BROAD SPECTRUM SPF 33TITANIUM DIOXIDE AND ZINC OXIDECosmetic Solutions LLCd65ae1c9-dff5-4612-b8be-fa59bba03b812026-01-30WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
58411-970-60584110970601 TUBE in 1 BOX (58411-970-60) / 50 mL in 1 TUBE1 tube2025-02-01NoNoCurrent