FDA.reportPublic FDA data

NDC 61354-070-01 - Cream

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
61354-070
Requested NDC
61354-070-01
Package NDCs from labels
61354-070-01, 61354-070-05, 61354-070-02, 61354-070-06, 61354-070-03, 61354-070-07, 61354-070-04, 61354-070-08
Manufacturer
Oxygen Development LLC
Effective date
2023-02-10
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Cream - Oxygen Development LLCOxygen Development LLC2023-02-10HUMAN OTC DRUG LABEL
cream - Oxygen Development LLCOxygen Development LLC2023-02-10HUMAN OTC DRUG LABEL
cream - Oxygen Development LLCOxygen Development LLC2023-02-10HUMAN OTC DRUG LABEL
cream - Oxygen Development LLCOxygen Development LLC2023-02-10HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Indexing SPL table
NDCEffectiveIndexing SPLRelated label
61354-070-052025-01-30f386c649-9eb5-0266-e053-dadaa90a7c1aWestmore Beauty 10-in-1 coverage perfector cc cream broad spectrum spf 25 sunscreen - Light
61354-070-062025-01-30f386c649-fb93-0266-e053-dadaa90a7c1aWestmore Beauty 10-in-1 coverage perfector CC cream broad spectrum spf 25 sunscreen - Deep
61354-070-072025-01-30f386c649-c989-0266-e053-dadaa90a7c1aWestmore Beauty 10-in-1 coverage perfector CC cream Broad spectrum spf 25 sunscreen - Fair
61354-070-082025-01-30f386c64a-3de1-0266-e053-dadaa90a7c1aWestmore Beauty 10-in-1 coverage perfector CC cream Broad spectrum spf 25 sunscreen - Medium
61354-070-052023-02-10f386c649-9eb5-0266-e053-dadaa90a7c1aWestmore Beauty 10-in-1 coverage perfector cc cream broad spectrum spf 25 sunscreen - Light
61354-070-062023-02-10f386c649-fb93-0266-e053-dadaa90a7c1aWestmore Beauty 10-in-1 coverage perfector CC cream broad spectrum spf 25 sunscreen - Deep
61354-070-072023-02-10f386c649-c989-0266-e053-dadaa90a7c1aWestmore Beauty 10-in-1 coverage perfector CC cream Broad spectrum spf 25 sunscreen - Fair
61354-070-082023-02-10f386c64a-3de1-0266-e053-dadaa90a7c1aWestmore Beauty 10-in-1 coverage perfector CC cream Broad spectrum spf 25 sunscreen - Medium
61354-070-052023-01-30f386c649-9eb5-0266-e053-dadaa90a7c1aWestmore Beauty 10-in-1 coverage perfector cc cream broad spectrum spf 25 sunscreen - Light
61354-070-062023-01-30f386c649-fb93-0266-e053-dadaa90a7c1aWestmore Beauty 10-in-1 coverage perfector CC cream broad spectrum spf 25 sunscreen - Deep
61354-070-072023-01-30f386c649-c989-0266-e053-dadaa90a7c1aWestmore Beauty 10-in-1 coverage perfector CC cream Broad spectrum spf 25 sunscreen - Fair
61354-070-082023-01-30f386c64a-3de1-0266-e053-dadaa90a7c1aWestmore Beauty 10-in-1 coverage perfector CC cream Broad spectrum spf 25 sunscreen - Medium

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61354-070-01Cream40 mg in 1 TUBECREAM403
61354-070-02cream40 mg in 1 TUBECREAM403
61354-070-03cream40 mg in 1 TUBECREAM403
61354-070-04cream40 mg in 1 TUBECREAM403
61354-070-05Cream1 in 1 CARTONCREAM13
61354-070-06cream1 in 1 CARTONCREAM13
61354-070-07cream1 in 1 CARTONCREAM13
61354-070-08cream1 in 1 CARTONCREAM13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61354-070CREAM (OCTINOXATE, ZINC OXIDE) CREAM [OXYGEN DEVELOPMENT LLC]3Legacy NDC, 2 package rows20230211_bbf4e4ca-8b3b-4298-e053-2995a90ad847.zip
61354-070CREAM (OCTINOXATE, ZINC OXIDE) CREAM [OXYGEN DEVELOPMENT LLC]3Legacy NDC, 2 package rows20230211_bbf07182-f7d7-3790-e053-2a95a90a3798.zip
61354-070CREAM (OCTINOXATE, ZINC OXIDE) CREAM [OXYGEN DEVELOPMENT LLC]3Legacy NDC, 2 package rows20230211_bbf2abeb-fe02-8422-e053-2a95a90ac374.zip
61354-070CREAM (OCTINOXATE, ZINC OXIDE) CREAM [OXYGEN DEVELOPMENT LLC]3Legacy NDC, 2 package rows20230211_bbf3d3af-f30e-5491-e053-2995a90a22bb.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 143 of 278 · 5,544 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Kinesys Broad Spectrum SPF 30 Kids Alcohol-Free SunscreenOCTINOXATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONEWilc Healthcare Inc9adea1a4-efa6-4fe1-85e8-ed69fa098a872025-10-10WarningsExact identifier
unii: 4Y5P7MUD51
Kinesys Broad Spectrum SPF 30 Alcohol-Free Sunscreen - Mango ScentOCTINOXATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONEWilc Healthcare Inc60e7ed8e-f421-4e08-97a8-af647200e4ae2025-10-10WarningsExact identifier
unii: 4Y5P7MUD51
KINeSYS Pro Sport Lip Balm with Shea Butter Broad Spectrum 30ZINC OXIDEWilc Healthcare Ince5820376-897f-4c77-aadc-7991137870b72025-10-10WarningsExact identifier
unii: SOI2LOH54Z
KINeSYS Pro Sport Clear Mineral Sunscreen Stick Broad Spectrum SPF45ZINC OXIDEWilc Healthcare Inc247a323f-9a08-4717-8553-ebc9c519817b2025-10-10WarningsExact identifier
unii: SOI2LOH54Z
Wonderscreen Broad Spectrum SPF 30ZINC OXIDEWasatch Product Development, LLC.e895d942-e50e-1ad6-e053-2995a90a0e022025-10-10WarningsExact identifier
unii: SOI2LOH54Z
Illuminating SPF 50 plus drops Broad Spectrum SunscreenZINC OXIDECosmetic Enterprise Ltd13f40485-b98e-e804-e063-6394a90af2af2025-10-10WarningsExact identifier
unii: SOI2LOH54Z
Impeccable Skin Moisturizing Face Sunscreen Broad Spectrum SPF 30ZINC OXIDECosmetic Enterprises LTDa84d246b-1153-85ff-e053-2995a90a270a2025-10-10WarningsExact identifier
unii: SOI2LOH54Z
MediChoice Moisturizing Lip Balm SPF15AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENEO&M HALYARD, INC.00327815-28f0-4198-bca7-c8ae768ff4162025-10-09WarningsExact identifier
unii: 4Y5P7MUD51
Daybird 4-in-1 Skin Tint SerumZINC OXIDEResette, Inc.19c1a934-b0f5-1068-e063-6294a90a3b1f2025-10-09WarningsExact identifier
unii: SOI2LOH54Z
pavise Lip Defense tinted hydrating oil (hue 604)ZINC OXIDEB.A.I. Biosciences INC.f4ebbc1d-d521-1a47-e053-2a95a90a6f842025-10-09WarningsExact identifier
unii: SOI2LOH54Z
pavise Lip Defense tinted hydrating oil (hue 774)ZINC OXIDEB.A.I. Biosciences INC.f4ebd850-11a8-0d43-e053-2a95a90a2d342025-10-09WarningsExact identifier
unii: SOI2LOH54Z
pavise Lip Defense tinted hydrating oil (hue 616)ZINC OXIDEB.A.I. Biosciences INC.f4eb6b20-7c26-2942-e053-2a95a90abd312025-10-09WarningsExact identifier
unii: SOI2LOH54Z
GlycerinGLYCERINH E B3d0566a1-57a5-6a31-e054-00144ff88e882025-10-09WarningsExact identifier
unii: PDC6A3C0OX
BEAUTY SHIELD BROAD SPECTRUM SUNSCREEN (Napoleon Perdis)ZINC OXIDENapoleon PerdisCosmetic Pty Ltdbe64bb40-b1a9-2308-e053-2a95a90a69c82025-10-09WarningsExact identifier
unii: SOI2LOH54Z
Organys Open Formula SheerZINC OXIDEOrganys Beauty0b3ab551-cb66-cf86-e063-6394a90a7ab42025-10-09WarningsExact identifier
unii: SOI2LOH54Z
Dr Lift Mineral SPF 50TITANIUM DIOXIDE, ZINC OXIDESpa de Soleil40c03d65-8d09-371a-e063-6294a90a7ac62025-10-09WarningsExact identifier
unii: SOI2LOH54Z
Organys Derma Made SheerZINC OXIDEOrganys Beauty0b39f550-bd34-509d-e063-6294a90a51d02025-10-09WarningsExact identifier
unii: SOI2LOH54Z
Organys Derma MadeZINC OXIDEOrganys Beauty0b37a73b-73ca-501f-e063-6294a90a62912025-10-09WarningsExact identifier
unii: SOI2LOH54Z
Organys Derma MadeZINC OXIDEOrganys Beauty09b8b8c0-4066-9cbe-e063-6394a90aca242025-10-09WarningsExact identifier
unii: SOI2LOH54Z
Daybird Tinted Skincare (SHADE 3)ZINC OXIDEResette, Incdc89ab76-da32-4f6f-e053-2995a90a8bcb2025-10-09WarningsExact identifier
unii: SOI2LOH54Z

Reported adverse events (FAERS/openFDA)#

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