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 183 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FENTY SKIN HYDRA VIZOR BROAD SPECTRUM MINERAL SPF 30 SUNSCREEN MOISTURIZER FRAGRANCE-FREEZINC OXIDEKENDO HOLDINGS INC19120c3f-8fc0-62c3-e063-6394a90a30f32025-09-30WarningsExact identifier
application number: M020
FENTY SKIN HYDRA VIZOR SPF 30AVOBENZONE, HOMOSALATE, OCTISALATEKENDO HOLDINGS INC1d26bfb0-3c05-4a0c-9d4b-8103592227302025-09-30WarningsExact identifier
application number: M020
FENTY SKIN HYDRA VIZOR BROAD SPECTRUM MINERAL SPF 30 SUNSCREEN MOISTURIZERZINC OXIDEKENDO HOLDINGS INCfd16def1-4c88-3ad0-e053-6294a90ab0882025-09-30WarningsExact identifier
application number: M020
FENTY SKIN HYDRA VIZOR BROAD SPECTRUM MINERAL SPF 15 SUNSCREEN HANDZINC OXIDEKENDO HOLDINGS INCf92b75bd-c5b7-0320-e053-6394a90ab4c32025-09-30WarningsExact identifier
application number: M020
OLE HENRIKSEN BANANA BRIGHT MINERAL SUNSCREEN SPF 30ZINC OXIDEKENDO HOLDINGS INCf92ae08e-0bca-4775-e053-6394a90ab3d62025-09-30WarningsExact identifier
application number: M020
Sun Kids mineral STRAWBERRY SUNSCREEN BROAD SPECTRUM SPF 50ZINC OXIDEThe Natural SKN Company400c67aa-55a6-67ea-e063-6294a90a02132025-09-30WarningsExact identifier
application number: M020
toty Ilumina CC Creamy Compact Refill 1CTITANIUM DIOXIDEChipican LLCf0596830-77ed-11f0-e053-2995a90a8ff52025-09-29WarningsExact identifier
application number: M020
U V-Lamp Shield Mani-SunscreenZINC OXIDE, TITANIUM DIOXIDEGUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD3fe7e1c3-e6cd-1420-e063-6394a90a41382025-09-28WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC053e76f0-8ca0-645d-e063-6394a90a01d22025-09-28WarningsExact identifier
application number: M020
Hawaiian Tropic Mineral Translucent Sunscreen Powder SPF 30ZINC OXIDEEdgewell Personal Care Brands LLCcdc54f23-0efb-2fb4-e053-2995a90ae58b2025-09-28WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC0540017a-52ac-7972-e063-6394a90a139c2025-09-28WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC08f3b27f-b233-d406-e063-6394a90ada762025-09-28WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC128a3772-b9b7-0d10-e063-6294a90a3e052025-09-28WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC203c82a2-0131-8023-e063-6294a90aba7b2025-09-28WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC203c780a-3107-d71a-e063-6394a90aca252025-09-28WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC31d01fae-4085-d84a-e063-6294a90ab9812025-09-28WarningsExact identifier
application number: M020
Hawaiian TropicAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands, LLC3388c2fa-8082-95d4-e063-6294a90a94b82025-09-28WarningsExact identifier
application number: M020
Neutrogena Beach Defense Water Plus Sun Protection Sunscreen Broad Spectrum SPF30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONEKenvue Brands LLCb10a7794-7e4f-412b-9eb2-773107ecb7fc2025-09-26WarningsExact identifier
application number: M020
Black Girl Sunscreen SPF 50HOMOSALATE 10.00% OCTOCRYLENE 10.00% OCTISALATE 5.00% AVOBENZONE 3.00%Black Girl Sunscreenfed22570-e0ae-43e1-b6ce-1f0ad01684c32025-09-26WarningsExact identifier
application number: M020
Smooth Even GlowTINTED SUNSCREEN BROAD SPF30SKNVcare, LLC3fa48151-fcb9-3d35-e063-6394a90a2eb62025-09-25WarningsExact 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