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 122 of 176 · 3,512 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Black Girl Sunscreen SPF 50 KidsAVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Derma Care Research Labs, LLCd53ff8f5-0b06-1e8b-e053-2a95a90ab9242024-12-19WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
Fresh Coast SPF 50 SunscreenAVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Derma Care Research Labs, LLC043cadde-ba07-7c77-e063-6394a90abee62024-12-19WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
Black Girl Sunscreen SPF 30AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 8%Derma Care Research Labs, LLCd438be95-0f88-69d7-e053-2995a90a982e2024-12-19WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
Pavin SPF 50 SunscreenAVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Derma Care Research Labs, LLCe945f9df-0aed-469c-e053-2995a90ab6aa2024-12-19WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
Bee Bald Smooth Plus Daily Moisturizer SPF 30 SunscreenAVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 2.7%, OXYBENZONE 6%Derma Care Research Labs, LLC051b68f9-5d6b-3cd7-e063-6394a90aeb352024-12-19WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
MKMen Advanced Facial Hydrator Sunscreen SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONEMary Kay Inc.484e92db-09a2-4e93-aa7e-d91dbda315552024-12-19WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
SPF 50 Sunscreen UnfragrancedAVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Derma Care Research Labs, LLC05e4706b-1955-aba8-e063-6294a90a29c72024-12-19WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
Rubber Ducky SPF 50 SunscreenAVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Derma Care Research Labs, LLCcf32b3a0-de88-b866-e053-2a95a90a3f322024-12-19WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
SPF 50 Sunscreen Rocky MountainAVOBENZONE 3%, HOMOSALATE 10%, OCTOCRYLENE 6%Derma Care Research Labs, LLCa216d48f-4ed4-6008-e053-2a95a90a8c9a2024-12-19WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: G63QQF2NOX
Rod and Rifle SPF 50 SunscreenAVOBENZONE 3%, HOMOSALATE 10%, OCTOCRYLENE 6%Derma Care Research Labs, LLCfc61847b-cb61-97b1-e053-6394a90ae1b92024-12-19WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: G63QQF2NOX
Habana Brisa SPF 30 SunscreenAVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 6%Derma Care Research Labs, LLCdb0d6dec-d0ee-6160-e053-2a95a90a2c6e2024-12-19WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
Caribbean Breeze SPF 30 SunscreenAVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 8%Derma Care Research Labs, LLCf8730f9c-43c1-f4d3-e053-6294a90a18092024-12-19WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
Caribbean Breeze SPF 50 SunscreenAVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Derma Care Research Labs, LLCf8735925-dcb2-6723-e053-6294a90a51f42024-12-19WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
Caribbean Breeze SPF 70 SunscreenAVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Derma Care Research Labs, LLCf873c125-86b8-3d1d-e053-6394a90a6bcf2024-12-19WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
Royal Boost Cover Me Sunscreen Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEDistribuidora Comercial Jafra, S.A. de C.V.efd7d887-0616-4c76-84d8-5370eb63cb7f2024-12-19WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
Rubber Ducky SPF 50 Unfragranced SunscreenAVOBENZONE 3%, HOMOSALATE 10%, OCTOCRYLENE 6%Derma Care Research Labs, LLC043b447c-4519-37ce-e063-6394a90a71972024-12-19WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: G63QQF2NOX
Australian Sands SPF 50 SunscreenAVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Derma Care Research Labs, LLCf886a02f-c043-b281-e053-6294a90af7462024-12-19WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
SPF 50 Sunscreen Rocky MountainAVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Derma Care Research Labs, LLCa1c9066c-4801-5aee-e053-2995a90a75d22024-12-19WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
Dr. Throwers SPF 30 Face and Body SunscreenAVOBENZONE 3%, HOMOSALATE 12%, OCTISALATE 5%, OCTOCRYLENE 3%Derma Care Research Labs, LLCd680b6f6-e1a9-47a4-e053-2a95a90ae3b02024-12-19WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
Vacation Broad Spectrum SPF 30HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONEVacation Inc.29a7636c-4d99-2cac-e063-6394a90a74802024-12-19WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W

Reported adverse events (FAERS/openFDA)#

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