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 163 of 175 · 3,495 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Brickell Mens Products Daily Defense Face Moisturizer SPF-20OCTISALATE, ZINC OXIDEBRICKELL BRANDS LLCa61e20e4-d5c9-4dc4-a18a-cc88b358d15c2023-11-11WarningsExact identifier
unii: 4X49Y0596W
EIGHT SAINTS Chase The Sun SPF-30OCTOCRYLENE, OCTISALATE, ZINC OXIDEBRICKELL BRANDS LLC9b19b2b4-d8b9-415d-a217-4a5ef3d75a8c2023-11-11WarningsExact identifier
unii: 5A68WGF6WM
unii: 4X49Y0596W
STRYX Daily Moisturizer SPF-30OCTISALATE, ENSULIZOLESTRYX MEN, INC.2bac4348-5b5d-41cc-893e-b9d5c1215ab02023-11-11WarningsExact identifier
unii: 4X49Y0596W
SIMPLI DAY All In One SmartCream SPF 42ZINC OXIDE, OCTISALATE, OCTOCRYLENE, ENSULIZOLESIMPLI SKIN MD LLCe5aab0ec-eda2-4073-998a-966202dc22332023-11-11WarningsExact identifier
unii: 5A68WGF6WM
unii: 4X49Y0596W
TANCEUTICALS SPF DROPS Broad Spectrum SPF-30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETANCEUTICALS, LLC8640b971-7c99-4c8f-ac5c-ecdd88b99fe02023-11-11WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
Ultra Replenishing Sunscreen SPF 40HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXYIDE CREAMCosMedical Technologies, LLC92ad5d7a-9adb-7d55-e053-2995a90a80e72023-11-10WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: 4X49Y0596W
Banana Boat Deep Tanning Sunscreen SPF 4AVOBENZONE,OCTISALATEEdgewell Personal Care Brands LLCab8623e2-0539-3f8f-e053-2a95a90a39d52023-11-09WarningsExact identifier
unii: G63QQF2NOX
unii: 4X49Y0596W
Private Label Sunscreen SPF35 40min WR RE126-202HOMOSALATE, ZINC OXIDE SUNSCREENSwiss-American CDMO, LLC254fa69f-2413-47e8-bc9b-5b7b0b59a5c82023-11-09WarningsExact identifier
unii: V06SV4M95S
unii: 4X49Y0596W
PLANTSCRIPTION SPF 25 POWER ANTI-AGING oil FREE BROAD SPECTRUMAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEORIGINS NATURAL RESOURCES INC.91c14980-ba63-4705-a465-581fe11d0a982023-11-08WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 0NOCTISALATE, TITANIUM DIOXIDEGuerlaina20dc51a-1f6c-4a6d-97f6-2f048e0689a02023-11-08WarningsExact identifier
unii: 4X49Y0596W
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 0.5COCTISALATE, TITANIUM DIOXIDEGuerlaina6c8b20f-6377-443b-a89b-8b5d40c65ad82023-11-08WarningsExact identifier
unii: 4X49Y0596W
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 0.5NOCTISALATE, TITANIUM DIOXIDEGuerlainb6591b2e-9e55-4f25-958c-f36f1ef857492023-11-08WarningsExact identifier
unii: 4X49Y0596W
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 1.5NOCTISALATE, TITANIUM DIOXIDEGuerlain6e2ae7cb-c390-4996-95e8-ae8fadefa8bd2023-11-08WarningsExact identifier
unii: 4X49Y0596W
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 1NOCTISALATE, TITANIUM DIOXIDEGuerlaina143c8cb-185c-4fd8-a901-3c0d9ffb82902023-11-08WarningsExact identifier
unii: 4X49Y0596W
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 1COCTISALATE, TITANIUM DIOXIDEGuerlain3d6e438d-9ea4-4253-9153-748d3c9742652023-11-08WarningsExact identifier
unii: 4X49Y0596W
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 2NOCTISALATE, TITANIUM DIOXIDEGuerlain173aeaab-a286-48ed-9033-10b13f547bbd2023-11-08WarningsExact identifier
unii: 4X49Y0596W
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 3.5NOCTISALATE, TITANIUM DIOXIDEGuerlaind877575a-25f3-49bd-b403-ecf6a1eb483a2023-11-08WarningsExact identifier
unii: 4X49Y0596W
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 5NOCTISALATE, TITANIUM DIOXIDEGuerlain24e1e576-9edd-45aa-a883-2a2d18a1cb5e2023-11-08WarningsExact identifier
unii: 4X49Y0596W
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 6NOCTISALATE, TITANIUM DIOXIDEGuerlaina8fffe38-5f90-4078-b553-30036659a2ee2023-11-08WarningsExact identifier
unii: 4X49Y0596W
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 7NOCTISALATE, TITANIUM DIOXIDEGuerlainbfa2b2be-958c-439f-b363-2623df2b85012023-11-08WarningsExact identifier
unii: 4X49Y0596W

Reported adverse events (FAERS/openFDA)#

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