FDA.reportPublic FDA data

NDC 84451-004-01 - OS-01 Lip SPF BS SPF15

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
84451-004
Requested NDC
84451-004-01
Package NDCs from labels
84451-004-01, 84451-004-02
Manufacturer
ONESKIN INC.
Effective date
2025-05-14
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Drug FactsONESKIN INC.2025-05-14HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84451-004-01OS-01 Lip SPF BS SPF1512 g in 1 TUBECREAM121
84451-004-02OS-01 Lip SPF BS SPF151 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84451-004OS-01 LIP SPF BS SPF15 (ZINC OXIDE) CREAM [ONESKIN INC.]1Current NDC, 2 package rows20250515_351d55f6-fcd9-1d47-e063-6294a90a2cf0.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 78 of 403 · 8,060 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SHISEIDO URBAN ENVIRONMENT FRESH-MOISTURE SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEShiseido Americas Corporationbf16e8b5-b717-4255-a7da-9abe3d1ad8b42026-01-30WarningsExact identifier
application number: M020
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
OptaseGLYCERINScope Health Inc10c3e31d-779d-8ff6-e063-6294a90acd392026-01-30WarningsExact identifier
unii: PDC6A3C0OX
OptaseGLYCERINScope Health Inc9e96976b-2990-79e0-e053-2995a90a0f292026-01-30WarningsExact identifier
unii: PDC6A3C0OX
OptaseGLYCERINScope Health Incd81c1a4f-87b0-ee8c-e053-2995a90af9e52026-01-30WarningsExact identifier
unii: PDC6A3C0OX
OptaseGLYCERINScope Health Incf452a2c4-c869-7bf5-e053-2995a90ac1a02026-01-30WarningsExact identifier
unii: PDC6A3C0OX
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
unii: SOI2LOH54Z
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
unii: SOI2LOH54Z
Touch in SOL No Poreblem Airbrushed PrimerOCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONEBONNE Co., Ltd4685ff24-0bb0-3502-e063-6394a90abfee2026-01-29WarningsExact identifier
application number: M020
Regener-Eyes Ophthalmic Solution LITE XLGLYCERIN OPHTHALMIC SOLUTIONM & M PRODUCTS, L.L.C.47ab9609-4291-30b2-e063-6394a90a421e2026-01-29WarningsExact identifier
unii: PDC6A3C0OX
Regener-Eyes Ophthalmic Solution PROFESSIONAL STRENGTH XLGLYCERIN OPHTHALMIC SOLUTIONM & M PRODUCTS, L.L.C.48d6dc98-66e8-b499-e063-6394a90ae9352026-01-29WarningsExact identifier
unii: PDC6A3C0OX
Zinc oxideZINC OXIDEAldi, Incd56782c1-b23c-47a9-82cb-d7dbb0ac7aa32026-01-29Warnings, Adverse reactionsExact identifier
unii: SOI2LOH54Z
Sheer Touch Sunscreen SPF 70AVOBENZONE, HOMOSALATE, OCTISALATEAldi, Incc7650d20-7cb9-4861-8a30-cf4a9cd424e92026-01-29Warnings, Adverse reactionsExact identifier
application number: M020
Sunscreen SPF 70AVOBENZONE, HOMOSALATE, OCTISALATEAldi, Inc32c0613e-0f5a-47f5-b2f3-f32ae07cbc762026-01-29Warnings, Adverse reactionsExact identifier
application number: M020
CalamineCALAMINEAMERISOURCE BERGEN90d9d908-57ea-4062-ade0-8a4888939c912026-01-29Warnings, Adverse reactionsExact identifier
unii: SOI2LOH54Z
OptaseGLYCERINScope Health Inc86c14327-ffc7-806e-e053-2991aa0aaf922026-01-29WarningsExact identifier
unii: PDC6A3C0OX
Vacation Original Coconut SPF 15AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEVacation INC.a9a0b558-b8e6-44ea-9b57-6938837a04fb2026-01-29WarningsExact identifier
application number: M020
SHISEIDO SPORTS BB DARKOCTINOXATE AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATIONf4fc4b6a-9507-496e-9ecb-8400055ecf2d2026-01-28WarningsExact identifier
application number: M020

Reported adverse events (FAERS/openFDA)#

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