FDA.reportPublic FDA data

SHISEIDO URBAN ENVIRONMENT oil-free MINERAL SUNSCREEN SPF 42

Product NDC
58411-672
11-digit product format
584110672
Labeler code
58411
Product ID
58411-672_4a014005-1de0-41fa-e063-6294a90a5544
Type
HUMAN OTC DRUG
Nonproprietary name
TITANIUM DIOXIDE 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
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
1.8; 5 g/30mL; g/30mL
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 oil-free MINERAL SUNSCREEN SPF 42
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TITANIUM DIOXIDE1.8 g/30mL
ZINC OXIDE5 g/30mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
15FIX9V2JPInternal 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
86630e82-f249-4866-82dd-3e21feb266c4Available 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
58411-672-10SHISEIDO URBAN ENVIRONMENT oil-free MINERAL SUNSCREEN SPF 421 in 1 CARTONEMULSION13
58411-672-10SHISEIDO URBAN ENVIRONMENT oil-free MINERAL SUNSCREEN SPF 4230 mL in 1 BOTTLEEMULSION303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58411-672SHISEIDO URBAN ENVIRONMENT OIL-FREE MINERAL SUNSCREEN SPF 42 (TITANIUM DIOXIDE AND ZINC OXIDE) EMULSION [SHISEIDO AMERICAS CORPORATION]2Current NDC, Legacy NDC, 2 package rows20240112_86630e82-f249-4866-82dd-3e21feb266c4.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 157 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Alba Botanica Sensitive Mineral SPF 50ZINC OXIDEThe Hain Celestial Group, Inc.4484b16f-f29a-60cc-e063-6294a90a2b9d2025-11-26WarningsExact identifier
application number: M020
Alba Botanica Sheer Mineral SPF50ZINC OXIDEThe Hain Celestial Group, Inc.0cf9c4b9-8e85-980c-e063-6394a90a9e7e2025-11-26WarningsExact identifier
application number: M020
Alba Botanica Sensitive Mineral SPF 30ZINC OXIDEThe Hain Celestial Group, Inc.44867882-d9c1-7389-e063-6294a90a7f772025-11-26WarningsExact identifier
application number: M020
Alba Botanica Sheer Mineral SPF30ZINC OXIDEThe Hain Celestial Group, Inc.0cf9361f-f292-6429-e063-6294a90add0e2025-11-26WarningsExact identifier
application number: M020
ZO Skin Health Gel Sunscreen Broad-Spectrum SPF 50AVOBENZONE, OCTISALATE, OCTOCRYLENEZO Skin Health, Inc.ec8386f2-9cb7-40f4-e053-2995a90ac2d82025-11-26WarningsExact identifier
application number: M020
WOODSLEEP Tallow SunscreenTITANIUM DIOXIDEShantou Woodsleep Biotechnology Co., Ltd.330a9f2e-7ce1-f83f-e063-6394a90a184a2025-11-26WarningsExact identifier
application number: M020
WOODSLEEP Tallow SunscreenTITANIUM DIOXIDEShantou Woodsleep Biotechnology Co., Ltd.33cdde09-e7ee-e003-e063-6394a90a87622025-11-26WarningsExact identifier
application number: M020
Native Mineral Suncare Zinc Oxide Sunscreen Tropical Breeze Broad Spectrum SPF 30ZINC OXIDEThe Procter & Gamble Manufacturing Company44718c3c-b081-bcfb-e063-6394a90a37862025-11-25WarningsExact identifier
application number: M020
Native Mineral Suncare Zinc Oxide Sunscreen Unscented Broad Spectrum SPF 30ZINC OXIDEThe Procter & Gamble Manufacturing Company4472cc1e-6b34-388b-e063-6394a90ac7b62025-11-25WarningsExact identifier
application number: M020
Native Mineral Suncare Zinc Oxide Sunscreen Pear and Coconut Water Broad Spectrum SPF 30ZINC OXIDEThe Procter & Gamble Manufacturing Company4472ef69-8992-fcab-e063-6294a90a6b902025-11-25WarningsExact identifier
application number: M020
Native Mineral Suncare Zinc Oxide Sunscreen Vanilla Milk and Shea Broad Spectrum SPF 30ZINC OXIDEThe Procter & Gamble Manufacturing Company44732f89-8ac3-8c5d-e063-6394a90aba732025-11-25WarningsExact identifier
application number: M020
Native Mineral Suncare Zinc Oxide Sunscreen Unscented Broad Spectrum SPF 30ZINC OXIDEThe Procter & Gamble Manufacturing Company447347d6-b8a3-7338-e063-6294a90abbf92025-11-25WarningsExact identifier
application number: M020
Native Mineral Suncare Zinc Oxide Sunscreen Pear and Coconut Water Broad Spectrum SPF 30ZINC OXIDEThe Procter & Gamble Manufacturing Company4473c4cc-f8b5-4a92-e063-6394a90ae6902025-11-25WarningsExact identifier
application number: M020
salmon colored sunscreenSALMON COLORED SUNSCREENGuangzhou Fantesy Biotechnology Co.,Ltd4477964b-28f3-a371-e063-6294a90a42302025-11-25WarningsExact identifier
application number: M020
Safe Sea SPF 50 MineralZINC OXIDENidaria Technology Ltd.f6cf9454-552b-486e-a38b-ab3c183b24a12025-11-24WarningsExact identifier
application number: M020
Safe Sea SPF 30ZINC OXIDENidaria Technology Ltd.91bf07ed-0be4-43c9-b5f3-4e8eb892bca52025-11-24WarningsExact identifier
application number: M020
Olay Complete UV365 Daily Moisturizer Sensitive Broad Spectrum SPF 15OCTINOXATE AND ZINC OXIDEThe Procter & Gamble Manufacturing Company5904baa8-3070-1d77-e053-2a91aa0a68522025-11-24WarningsExact identifier
application number: M020
it cosmetics Bye Bye Foundation Full Coverage Moisturizer with 3D Skin Flex Broad Spectrum SPF 50 Plus UVA UVB Physical Sunscreen All ShadesTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA, Inc.86eea4df-4191-4e05-9f05-4a98ef8c2a4d2025-11-24WarningsExact identifier
application number: M020
Cetaphil Sun Tinted Face SPF 40TITANIUM DIOXIDE, ZINC OXIDEGalderma Laboratories, L.P.22413f93-7219-4726-b741-2392e576b34a2025-11-24WarningsExact identifier
application number: M020
VEIL MINERAL PRIMER SUNSCREEN BROAD SPECTRUM SPF 15ZINC OXIDE AND TITANIUM DIOXIDEKingdom Animalia, LLC DBA Hourglass Cosmetics28e23498-953f-47c0-838c-bbf0e858d9032025-11-24WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58411-672-10584110672101 BOTTLE in 1 CARTON (58411-672-10) / 30 mL in 1 BOTTLE1 bottle2022-01-010000-00-00NoNoCurrent