FDA.reportPublic FDA data

NDC 61354-047-01 - Sunscreen

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
61354-047
Requested NDC
61354-047-01
Package NDCs from labels
61354-047-01, 61354-047-02, 61354-047-03, 61354-047-04
Manufacturer
Oxygen Development, LLC
Effective date
2023-02-03
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Sunscreen - Oxygen Development, LLCOxygen Development, LLC2023-02-03HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61354-047-042025-01-30C16284748780-12cef2736-8b50-d83d-e063-dadaa90ab31fBroad Spectrum Sunscreen Clear as Day SPF 46 Starface

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61354-047-01Sunscreen100 mg in 1 TUBEGEL1002
61354-047-02Sunscreen1 in 1 PACKAGEGEL12
61354-047-03Sunscreen1 in 1 CARTONGEL12
61354-047-04Sunscreen1 in 1 PACKAGEGEL12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61354-047SUNSCREEN (HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE) GEL [OXYGEN DEVELOPMENT, LLC]2Legacy NDC, 4 package rows20230204_d7fe4990-507e-4062-e053-2a95a90ae6d9.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 125 of 176 · 3,512 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
QC SPF 50 SunscreenAVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%CDMAf82080b1-ef90-a027-e053-6294a90a19f22024-12-15WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
QC SPF 30 SunscreenAVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 6%CDMAf80ceb05-0bd4-1355-e053-6294a90afb192024-12-15WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
BOBBI BROWN PRIMER PLUS PROTECTION BROAD SPECTRUM SPF50AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,AND OXYBENZONEBobbi Brown Professional Cosmetics Inc.03372376-ef03-943d-e063-6394a90a52ee2024-12-13WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
Mentholatum Natural Ice CherryDIMETHICONE, OCTINOXATE, OCTISALATEThe Mentholatum Company33f43f14-8e0b-41b1-8ad0-5723d2a7bf192024-12-13WarningsExact identifier
unii: 4X49Y0596W
Walgreens Scar Cream w/SPF 30AVOBENZONE3%,OCTOCRYLENE10%,OXYBENONE 6%Walgreenscc72c8c5-f3e9-e8e0-e053-2a95a90ae0b02024-12-11WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
ERBORIAN - CC CREME HIGH DEFINITION SPF 25OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDELABORATOIRES M&L3421b9a3-6551-406f-af3a-b3da8a01d2b22024-12-11WarningsExact identifier
unii: 4X49Y0596W
ERBORIAN CC RED CORRECT SPF 25OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDELaboratoires M&L21530925-03b7-40bb-9836-6ee4011c4a792024-12-11WarningsExact identifier
unii: 4X49Y0596W
ERBORIAN CC CREME HIGH DEFINITION SPF 25 CARAMELOCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDELABORATOIRES M&L70a5537c-a364-4dae-8ab2-8ca0cbfd11b72024-12-11WarningsExact identifier
unii: 4X49Y0596W
ERBORIAN - CC CREME HIGH DEFINITION SPF25 CLAIROCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDELABORATOIRES M&Lb55be8cb-7f21-45b0-bb8f-a60182077ca32024-12-11WarningsExact identifier
unii: 4X49Y0596W
SISLEYA Global Anti-Age Hand care SPF 15AVOBENZONE, OCTINOXATE, OCTISALATEC.F.E.B. Sisleycddf11b1-a89b-4b54-b228-55ba8147f0222024-12-10WarningsExact identifier
unii: G63QQF2NOX
unii: 4X49Y0596W
SUNLEYA Age minimizing sun care SPF 15AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEC.F.E.B. Sisley67498d45-0871-4806-8854-81d3e50c4b902024-12-10WarningsExact identifier
unii: G63QQF2NOX
unii: 4X49Y0596W
SUPER CREME SOLAIRE CORPS Body sun care SPF 15AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEC.F.E.B. Sisley1c774aa7-8963-4221-b4b0-b894bd1b941f2024-12-10WarningsExact identifier
unii: G63QQF2NOX
unii: 4X49Y0596W
SUNLEYA Age minimizing sun care SPF 50 plusAVOBENZONE, HOMOSALTE, OCTISALATE, OCTOCRYLENEC.F.E.B. Sisley7c9fadaf-b961-4df0-89ae-87141b50b2c12024-12-10WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
BANANA BOATAVOBENZONE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC28f08236-1f01-d759-e063-6294a90adcfa2024-12-10WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
unii: 4X49Y0596W
Blistex Five Star Lip Protection Broad SpectrumHOMOSALATE, OCTISALATE, AVOBENZONE, AND DIMETHICONEBlistex Inc.47b57317-7df5-442e-a3a4-1d44fe278ac62024-12-10WarningsExact identifier
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
Deep Renewal Broad SpectrumDIMETHICONE, AVOBENZONE, HOMOSALATE, AND OCTISALATEBlistex Inc11c0e084-dc40-4969-a176-3af4116d6f272024-12-10WarningsExact identifier
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
AHAVA Brightening Broad Spectrum SPF 20AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEAHAVA - Dead Sea Laboratories Ltd724bbb91-e273-4926-9ad6-a1657ffe4cd82024-12-10WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
BANANA BOAT KIDS SPF 65 CLEAR SUNSCREENAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLCdc7b0d17-d7c8-433f-e053-2995a90a477d2024-12-09WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
Prevention Daily Matte Moisturizer SPF 30ZINC OXIDE AND HOMOSALATEAllure Labsf0fb1b69-53f2-efff-e053-2995a90af9d42024-12-09WarningsExact identifier
unii: V06SV4M95S
Prevention Clear Solar Gel SPF30AVOBENZON, OCTISALATE AND OCTOCRYLENEAllure LAbsf19f6d9b-5249-27a6-e053-2a95a90a8a392024-12-09WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
unii: 4X49Y0596W

Reported adverse events (FAERS/openFDA)#

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