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 169 of 175 · 3,495 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Orange Creamsicle SPF 15 Broad Spectrum Lip BalmORANGE CREAMSICLE SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inca9005cb1-ae1a-7736-e053-2995a90a28ea2023-10-23WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
unii: 4X49Y0596W
Neora Age IQ Invisi-Bloc SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENENeora, LLCf2f3601f-081a-4bae-e053-2a95a90a4fac2023-10-23WarningsExact identifier
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
Neora Age IQ Invisi-Bloc SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENENeora, LLC82f48635-1dc4-8c0d-e053-2991aa0a60cc2023-10-23WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
CoreTex Sun X SPF 30 ThinAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONECoreTex Products Inc980388b5-8314-3143-e053-2995a90a72882023-10-22WarningsExact identifier
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
CoreTex Sun X SPF 30 Multipack NewAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECoreTex Productsf4ed9d7f-2d03-87d1-e053-2a95a90a3b4f2023-10-22WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
Artistry Skin Nutrition BALANCING Matte DayAVOBENZONE, OCTISALATE, OCTOCRYLENEAccess Business Group LLCd4a87153-7ef0-4365-ad91-dced9b1d80552023-10-21WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
unii: 4X49Y0596W
Artistry Skin Nutrition HYDRATING DayAVOBENZONE, OCTISALATE, OCTOCRYLENEAccess Business Group LLC06313228-7a79-48c5-8fd0-b210da6d037b2023-10-21WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
unii: 4X49Y0596W
Artistry Skin Nutrition RENEWING Reactivation Day SPF 30AVOBENZONE, OCTISALATE, OCTOCRYLENEAccess Business Group LLCbd4818b3-d5db-4812-96ec-1bd91aa1508b2023-10-21WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
unii: 4X49Y0596W
Artistry Skin Nutrition RENEWING Reactivation Day Cream SPF 30AVOBENZONE, OCTISALATE, OCTOCRYLENEAccess Business Group LLC4a0af0e9-04da-4b5f-a57a-967bef7257892023-10-21WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
unii: 4X49Y0596W
CLINIQUE FOR MEN BROAD SPECTRUM SPF 21 MOISTURIZERAVOBENZONE, OCTINOXATE, OCTISALATE, AND OXYBENZONECLINIQUE LABORATORIES LLC2e9463df-1c71-465f-9820-6cedefe07ad72023-10-20WarningsExact identifier
unii: G63QQF2NOX
unii: 4X49Y0596W
EVEN BETTER SKIN TONE CORRECTING MOISTURIZER BROAD SPECTRUM SPF 20AVOBENZONE, OCTISALATE, AND OCTOCRYLENECLINIQUE LABORATORIES LLC2ccf568b-b8ff-414d-b15d-0cab6a57a8012023-10-20WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
unii: 4X49Y0596W
SUPERDEFENSE BROAD SPECTRUM SPF 25 FATIGUE PLUS 1ST SIGNS OF AGE MULTI-CORRECTING VERY DRY TO DRY COMBINATIONAVOBENZONE, HOMOSALATE, AND OCTISALATECLINIQUE LABORATORIES LLCb0e9edb6-0bc6-4e5b-93ab-b3bdbf3f8be02023-10-19WarningsExact identifier
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
Broad Spectrum SPF 15 Sunscreen Vanilla Mint Lip BalmBROAD SPECTRUM SPF 15 SUNSCREEN VANILLA MINT LIP BALMRaining Roseefe25551-777c-5336-e053-2a95a90a5c232023-10-18WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
unii: 4X49Y0596W
Strawberry Limoncello SPF 15 Broad Spectrum Lip BalmSTRAWBERRY LIMONCELLO SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Incc222bd6e-59b0-394a-e053-2995a90ae4292023-10-18WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
unii: 4X49Y0596W
Raspberry Lime Margarita SPF 15 Broad Spectrum Lip BalmRASPBERRY LIME MARGARITA SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Incc2150247-ff7d-9863-e053-2995a90a3f012023-10-18WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
unii: 4X49Y0596W
Key Lime Pie Shake SPF 15 Broad Spectrum Lip BalmKEY LIME PIE SHAKE SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Incc214e5c2-53ea-31bd-e053-2995a90a886a2023-10-18WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
unii: 4X49Y0596W
Summer Sangria SPF 15 Broad Spectrum Lip BalmSUMMER SANGRIA SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Incc222cc2d-232c-0f3d-e053-2995a90af79b2023-10-18WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
unii: 4X49Y0596W
Tropical Mint Broad Spectrum SPF 15 Lip MoisturizerTROPICAL MINT SPF 15 BROAD SPECTRUM LIP MOISTURIZERRaining Rose, Incaef6b419-efac-4e37-e053-2995a90a0d2f2023-10-18WarningsExact identifier
unii: G63QQF2NOX
Broad Spectrum SPF 15 Sunscreen Cherry Lip BalmBROAD SPECTRUM SPF 15 SUNSCREEN CHERRY LIP BALMRaining Roseefbd2179-5f6d-a8c6-e053-2a95a90a17e72023-10-18WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
unii: 4X49Y0596W
Vanilla Mint Broad Spectrum SPF 15 Lip MoisturizerVANILLA MINT SPF 15 BROAD SPECTRUM LIP MOISTURIZERRaining Rose, Incaf10a007-6597-2231-e053-2995a90a87172023-10-18WarningsExact identifier
unii: G63QQF2NOX

Reported adverse events (FAERS/openFDA)#

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