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 55 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CENTELLA SUNSCREEN CreamZINC OXIDEYunqi Cosmetics (Shenzhen) Co., Ltd4cbac4e9-7540-f703-e063-6394a90ad8082026-03-11WarningsExact identifier
application number: M020
Vacation Lip BalmAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEVacation INC.4ba8ed52-2f52-40b9-a810-8450f9b907782026-03-10WarningsExact identifier
application number: M020
COOLA Zinc Oxide BodyLotion SPF 50 Fragrance-FreeZINC OXIDECOOLA LLC4cad89a5-325c-b3c2-e063-6294a90ac2252026-03-10WarningsExact identifier
application number: M020
Olay Complete plus Facial Moisturizer with Sunscreen Broad Spectrum SPF 40 SensitiveAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEThe Procter & Gamble Manufacturing Company4caf2ab5-76cb-4b0f-e063-6294a90a233e2026-03-10WarningsExact identifier
application number: M020
EWC Slow Lightweight Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATEEWC Ventures, LLC063426b8-d1cf-4ee2-8ab8-ff007227eab82026-03-10WarningsExact identifier
application number: M020
Olay Vitamin C Brightening Facial Moisturizer with Sunscreen Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEThe Procter & Gamble Manufacturing Company4cb268ea-f2b5-ddd1-e063-6394a90a1e962026-03-10WarningsExact identifier
application number: M020
Vacation Grand Cuvee Shimmer SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEVacation INC.e0b3d90b-ba56-43e5-aa68-8e5f473628ff2026-03-09WarningsExact identifier
application number: M020
La Roche Posay Laboratoire Dermatologique ANTHELIOS UVPRO SPORT INVISIBLE SUNSCREEN BROAD SPECTRUM SPF 45AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEL'Oreal USA, Inc.77f46325-600c-40ff-94fc-ea82d43134c22026-03-09WarningsExact identifier
application number: M020
Civant 50 Sunscreen Broad Spectrum SPF 50OCTOCRYLENE, ZINC OXIDECivant LLCe23622b8-49dd-45b9-8c51-1a83181cc7bd2026-03-09WarningsExact identifier
application number: M020
HydroScreenHOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONEMETHODIQ INC.4c9d5dfd-d790-fffc-e063-6294a90a4d302026-03-09WarningsExact identifier
application number: M020
Sunsei SPF 45 SunscreenZINC OXIDEShimoda Prime Products, LLC3d48e3e2-18c7-e004-e063-6294a90af4f22026-03-09WarningsExact identifier
application number: M020
Sunsei SPF 30 SunscreenZINC OXIDEShimoda Prime Products, LLC68df620b-7c1c-448c-93fd-91459e393c642026-03-09WarningsExact identifier
application number: M020
EADEM SUNSUEDE DAILY SUNSCREEN AND BLURRING PRIMER SPF50 PLUSAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEEADEM, Inc.4ca05e2f-f0c5-821c-e063-6294a90a90b82026-03-09WarningsExact identifier
application number: M020
COOLA SunBlur Primer SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECOOLA LLC4c6439e8-abda-663a-e063-6394a90ac43b2026-03-06WarningsExact identifier
application number: M020
COOLA SunBlur Makeup Mist SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECOOLA LLC4c666a82-293e-06df-e063-6294a90ad5512026-03-06WarningsExact identifier
application number: M020
No 7 Restore and Renew Multi Action Fragrance Free Day Cream SPF 25AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENEBCM Cosmetique SAS4d6d1fda-da78-62ed-e063-6294a90ac1052026-03-06WarningsExact identifier
application number: M020
Palio Sunscreen Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATESole Palio LLC071d5113-8fe8-44bb-8322-542eafc2800a2026-03-05WarningsExact identifier
application number: M020
Olay Age Defying Classic Broad Spectrum SPF 15OCTINOXATE AND ZINC OXIDEThe Procter & Gamble Manufacturing Company4c49dbf1-d1fe-ad4a-e063-6394a90af1512026-03-05WarningsExact identifier
application number: M020
SPF 70 Kids SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEDerma Care Research Labs, LLC0aadc378-dc34-9a37-e063-6294a90ad49e2026-03-05WarningsExact identifier
application number: M020
cle de peau BEAUTE RADIANT FLUID FOUNDATION NATURAL B50OCTINOXATE AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATION4490f968-46b6-44d2-af2d-5130b52c88612026-03-05WarningsExact 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