FDA.reportPublic FDA data

NDC 84451-003-01 - OS-01 Face SPF BS SPF30 Untinted

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
84451-003
Requested NDC
84451-003-01
Package NDCs from labels
84451-003-01, 84451-003-02
Manufacturer
ONESKIN INC.
Effective date
2024-09-13
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Drug FactsONESKIN INC.2024-09-13HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84451-003-01OS-01 Face SPF BS SPF30 Untinted40 g in 1 TUBECREAM401
84451-003-02OS-01 Face SPF BS SPF30 Untinted1 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84451-003OS-01 FACE SPF BS SPF30 UNTINTED (ZINC OXIDE) CREAM [ONESKIN INC.]1Current NDC, 2 package rows20240915_2205ec0e-ac3f-299f-e063-6294a90a2174.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 191 of 401 · 8,012 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Land Shark SPF 30 Clear ZincZINC OXIDE AND TITANIUM DIOXIDETropical Seas, Inc.d128269b-73fa-e5f3-e053-2995a90af1ed2025-11-04WarningsExact identifier
application number: M020
unii: SOI2LOH54Z
Land Shark SPF 50 SportOCTOCRYLENE, OCTISALATE, AND AVOBENZONETropical Seas, Inc.b5e40a7c-b49d-cfc3-e053-2995a90ac27e2025-11-04WarningsExact identifier
application number: M020
Reef Babies SPF 50 Oxybenzone FreeOCTOCRYLENE, OCTISALATE, AND AVOBENZONETropical Seas, Inc.d5ed3488-aa32-4a63-9996-12c6532c3a4d2025-11-04WarningsExact identifier
application number: M020
Land Shark SPF 30OCTOCRYLENE, OCTISALATE, AVOBENZONETropical Seas, Inc.b559499c-6109-bf5e-e053-2995a90a4ac72025-11-04WarningsExact identifier
application number: M020
Land Shark SPF 50OCTOCRYLENE, OCTISALATE, AND AVOBENZONETropical Seas, Inc.b5e24ca1-d041-355d-e053-2995a90a3d612025-11-04WarningsExact identifier
application number: M020
Land Shark SPF 30OCTOCRYLENE, OCTISALATE, AND AVOBENZONETropical Seas, Inc.b5570cbd-89f5-65d5-e053-2995a90a54d12025-11-04WarningsExact identifier
application number: M020
Land Shark Zinky SPF 36 Azure BlueZINC OXIDETropical Seas, Inc.d23fe61a-3ffb-59d0-e053-2995a90a59e62025-11-04WarningsExact identifier
application number: M020
unii: SOI2LOH54Z
Land Shark SPF 30OCTOCRYLENE, OCTISALATE, AVOBENZONETropical Seas, Inc.b55a0bd0-2a32-2977-e053-2a95a90aa1422025-11-04WarningsExact identifier
application number: M020
Expedition BackCountry SPF 30OCTOCRYLENE, OCTISALATE, AVOBENZONETropical Seas, Inc.06d43525-86d8-f2d9-e063-6394a90afc812025-11-04WarningsExact identifier
application number: M020
Land Shark Zinky SPF 36 Pacific PurpleZINC OXIDETropical Seas, Inc.d240fe7c-9d16-78c9-e053-2a95a90a763c2025-11-04WarningsExact identifier
application number: M020
unii: SOI2LOH54Z
Expedition BackCountry SPF 50OCTOCRYLENE, OCTISALATE, AND AVOBENZONETropical Seas, Inc.06c1ac52-474c-db5c-e063-6294a90afb5f2025-11-04WarningsExact identifier
application number: M020
Land Shark SPF 30 Tinted ZincZINC OXIDE AND TITANIUM DIOXIDETropical Seas, Inc.d1287899-f178-6124-e053-2a95a90a95a52025-11-04WarningsExact identifier
application number: M020
unii: SOI2LOH54Z
Naked Sundays BeautyScreen Peptide Foundation TintZINC OXIDENaked Sundays1a623dfc-a8fc-858b-e063-6294a90a9c112025-11-04WarningsExact identifier
application number: M020
unii: SOI2LOH54Z
Odacite Mineral Drops Sheer SunscreenZINC OXIDEOdacite303f3af6-631a-57a8-e063-6294a90addda2025-11-04WarningsExact identifier
application number: M020
unii: SOI2LOH54Z
MedlineZINC OXIDEMedline Industries, LPcadba3bc-4a06-872a-e053-2995a90ab4472025-11-04WarningsExact identifier
application number: M020
unii: SOI2LOH54Z
Sandra Plasencia Dendrobium Officinale Soothing Biofermented MaskTITANIUM DIOXIDEGuangzhou Meijiao Medical Biotechnology Co., Ltd.3cdf06f2-63f2-7a59-e063-6294a90a72ea2025-11-03WarningsExact identifier
unii: SOI2LOH54Z
Perricone MD Hypoallergenic CBD Sensitive Skin Therapy Ultra-Lightweight Calming SPF 35 VeilZINC OXIDETHG Beauty USA LLC2392c772-c251-1597-e063-6394a90a52f22025-11-03WarningsExact identifier
application number: M020
unii: SOI2LOH54Z
Hawaiian Tropic everyday Active Sport Sunscreen SPF50AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care LLCdc7d0757-c8a2-7fdb-e053-2a95a90a52822025-11-03WarningsExact identifier
application number: M020
MD Mineral BB Creme Broad Spectrum SPF 50 Water Resistant (80min) Mineral Sunscreen LIGHTTITANIUM DIOXIDE AND ZINC OXIDEMDSolarSciencesa7f906f6-3041-4c24-955d-90cdd402dd022025-11-03WarningsExact identifier
application number: M020
unii: SOI2LOH54Z
Calamine Plus Pramoxine HClCALAMINE PLUS NO TOUCH SPRAYPremier Brands of America Inc.36481d67-2346-470b-e063-6294a90aae992025-11-03WarningsExact identifier
unii: SOI2LOH54Z

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.