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 70 of 176 · 3,512 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Leader General Protection SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECARDINAL HEALTH, INC.9544b046-055e-5886-e053-2a95a90ad09e2025-12-02WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
BANANA BOATAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC44fe0844-cb74-7a04-e063-6294a90aca152025-12-02WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
CLINIQUE FOR MEN DAILY HYDRATOR BROAD SPECTRUM SPF 35AVOBENZONE,HOMOSALATE,OCTISALATE, AND OCTOCRYLENECLINIQUE LABORATORIES LLC44fe7468-001c-f2ee-e063-6394a90ae3b42025-12-02WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
BANANA BOATAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC44ffd469-0205-846f-e063-6294a90af6b52025-12-02WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
COSRXVITAMIN E VITALIZING SUNSCREENCOSRX inc.daf0291e-770c-eaf2-e053-2a95a90a0b672025-12-01WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
Centellian24 Madeca Derma Shield Vital Dewy SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTROCRYLENE7054144e0098c-170f-ca51-e063-6294a90aed202025-12-01WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
Centellian24 Madeca Derma Shield Vital Sun EssenceAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE7054144e194cd-ea61-71b3-e063-6394a90ac4862025-12-01WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
CHARLOTTE TILBURY Broad Spectrum SPF 50 Sunscreen Invisible UV Flawless Poreless PrimerAVOBENZONE, OCTINOXATE, OCTISALATE AND OCTOCRYLENECharlotte Tilbury Beauty Ltd.2b215ecb-7c3a-63db-e063-6394a90aa88f2025-12-01WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
unii: 4X49Y0596W
P.CALM Water Barrier Sunscreen SPF 50 Broad SpectrumHOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONELIFE WITHCORPORATION Inc.44ea9fb4-8e01-6969-e063-6294a90a6a942025-12-01WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
RoC Barrier Renew AM Moisturizer SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENERoC Skincare020aa79f-4fd6-1ea1-e063-6394a90a44642025-12-01WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
ROC MULTI CORREXION - EVEN TONE AND LIFT - 5-In-1 Chest, Neck, and Face Cream Sunscreen - Broad Spectrum SPF 30AVOBENZONE, HOMOSALATA, OCTISALATE, OCTOCRYLENERoc Skincare2b3656d6-4b3a-9ef2-e063-6294a90acaa62025-12-01WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
UNCOMPLIKATED MAKEUP SETTING SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONERare Beauty Brands Inc.44ec0db5-4437-e4a3-e063-6294a90a9a002025-12-01WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
RoC Retinol Correxion Wrinkle Correct Daily Moisturizer SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENERoC Skincare2888a198-116b-8441-e063-6394a90a0f952025-12-01WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
Jane Seymour Natural Advantage AM SPF 15 All Day Moisture with AHAsAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONEGuthy-Renker,LLC76298090-e873-4307-8bdb-19cdab6d9ac22025-12-01WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
ZO Skin Health Gel Sunscreen Broad-Spectrum SPF 50AVOBENZONE, OCTISALATE, OCTOCRYLENEZO Skin Health, Inc.ec8386f2-9cb7-40f4-e053-2995a90ac2d82025-11-26WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
unii: 4X49Y0596W
salmon colored sunscreenSALMON COLORED SUNSCREENGuangzhou Fantesy Biotechnology Co.,Ltd4477964b-28f3-a371-e063-6294a90a42302025-11-25WarningsExact identifier
unii: 5A68WGF6WM
Walgreens Invisible Lip BalmAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWalgreens43c039e0-f031-446c-bf19-7eac5bbdf4822025-11-24WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
BANANA BOATAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC203c9d86-45d7-efcc-e063-6394a90acefb2025-11-23WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
Aveeno Protect Plus Hydrate Sunscreen Broad Spectrum Body SPF 60AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLC615c5349-7fff-4145-9d65-1687247163be2025-11-21WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
Aveeno Protect Plus Hydrate Sunscreen Broad Spectrum Face SPF 60AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLC3cee59ad-f5e1-487d-b9cc-597664c62dac2025-11-21WarningsExact 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.