FDA.reportPublic FDA data

NDC 61354-070-04 - 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
61354-070-04
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 47 of 279 · 5,561 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ANTI-AGING TINTED SUNSCREENTITANIUM DIOXIDE, ZINC OXIDELASER GIRL SKINCARE, LLC4b93cd22-1289-29bc-e063-6294a90ab7812026-02-24WarningsExact identifier
unii: SOI2LOH54Z
ANTI-AGING TINTED SUNSCREENTITANIUM DIOXIDE, ZINC OXIDELASER GIRL SKINCARE, LLC4b943d72-dcde-e2e4-e063-6294a90ab7c42026-02-24WarningsExact identifier
unii: SOI2LOH54Z
ANTI-AGING NON-TINTED SUNSCREENTITANIUM DIOXIDE, ZINC OXIDELASER GIRL SKINCARE, LLC4b946c39-718b-d70e-e063-6394a90a0db82026-02-24WarningsExact identifier
unii: SOI2LOH54Z
SHISEIDO URBAN ENVIRONMENT MINERAL CLEAR SUNSCREENTITANIUM DIOXIDE, ZINC OXIDEShiseido Americas Corporationb93f10dc-193d-4cda-94b6-3f0e54d89f212026-02-23WarningsExact identifier
unii: SOI2LOH54Z
SHISEIDO ULTIMATE SUN PROTECTOR MINERALTITANIUM DIOXIDE AND ZINC OXIDESHISEIDO AMERICAS CORPORATION5e31eee8-6532-47ea-99fc-22418791804b2026-02-23WarningsExact identifier
unii: SOI2LOH54Z
Zinc Oxide and MentholZINC OXIDE, MENTHOLAkron Formulations India Private Limited4b84556c-521f-eebd-e063-6394a90a8e1e2026-02-23WarningsExact identifier
unii: SOI2LOH54Z
Eryfotona AgelessZINC OXIDEISDIN Corp.a58ac2ed-31b7-4a86-83ca-7630b0c9ea6f2026-02-23WarningsExact identifier
unii: SOI2LOH54Z
Perfect Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDESKIN PERFECT MEDICAL4b47e7cb-17d6-6a7c-e063-6294a90abbea2026-02-20WarningsExact identifier
unii: SOI2LOH54Z
CalamineFERRIC OXIDE REDPerrigo Direct, Inc256bd1d4-fd50-408f-9aee-84f218bb49712026-02-19Warnings, Adverse reactionsExact identifier
unii: SOI2LOH54Z
Diaper RashZINC OXIDEMeijer, Inc.1b72f927-c2ae-4190-a035-5d7bb9f53c152026-02-19Warnings, Adverse reactionsExact identifier
unii: SOI2LOH54Z
Beauty HydratingHOMOSALATE, ZINC OXIDEMeijer, Inc.69b72139-757f-476d-99d2-33f5524c41d22026-02-19Warnings, Adverse reactionsExact identifier
unii: SOI2LOH54Z
Baby Diaper RashZINC OXIDEMeijer, Inc.04bec667-a11e-42d2-a4b3-1416eebf1e8d2026-02-19Warnings, Adverse reactionsExact identifier
unii: SOI2LOH54Z
CalprotectMENTHOL, ZINC OXIDEReliable 1 Laboratories LLC09fb2810-0cc1-b2e2-e063-6294a90a45762026-02-19WarningsExact identifier
unii: SOI2LOH54Z
Allay Skin Solutions Protect Nourish Mineral Sunscreen SPF 42TITANIUM DIOXIDE, ZINC OXIDEALLAY SKIN SOLUTIONS LLC425bf1d7-f2cf-4237-9047-dd53054acd1c2026-02-18WarningsExact identifier
unii: SOI2LOH54Z
Diaper RashZINC OXIDETarget Corporation7fb5f9ca-cd90-4933-9fe8-907ece00458b2026-02-18Warnings, Adverse reactionsExact identifier
unii: SOI2LOH54Z
CalamineFERRIC OXIDE REDTarget Corporationd4ee05c8-ae62-45df-8783-1ed57fa030ec2026-02-18Warnings, Adverse reactionsExact identifier
unii: SOI2LOH54Z
Diaper RashZINC OXIDETarget Corporation8059f489-f144-4de5-9454-ac6c1af35dd22026-02-18Warnings, Adverse reactionsExact identifier
unii: SOI2LOH54Z
Dermatone Mineral SPF 30ZINC OXIDE 20%Dermatone Labs LLC26e3209f-cb5c-484e-9b2e-74dc397d47902026-02-18WarningsExact identifier
unii: SOI2LOH54Z
Mitochondria ProARALIA QUINQUEFOLIA, ARNICA MONTANA, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-KETOGLUTARICUM ACIDUM, ASCORBICUM ACIDUM, ALPHA-LIPOICUM ACIDUM, CALCAREA CARBONICA, CITRICUM ACIDUM, CUPRUM METALLICUM, CYSTEINUM, FERRUM METALLICUM, IODIUM, LEVOTHYROXINUM, MAGNESIUM GLUCONICUM DIHYDRICUM, MALICUM ACIDUM, MANGANUM ACETICUM, NADIDUM, NATRUM PYRUVICUM, NICOTINAMIDUM, PYRIDOXINUM HYDROCHLORICUM, RIBOFLAVINUM, SELENIUM METALLICUM, SULPHUR, THIAMINUM HYDROCHLORICUM, UBIDECARENONUM, ZINCUM METALLICUM,Energique, Inc.2f365207-b730-428d-9465-8853e86e79ff2026-02-18WarningsExact identifier
unii: 25X51I8RD4
cle de peau BEAUTE SYNACTIF DAYTIME MOISTURIZER ENRICHED nAVOBENZONE, OCTINOXATE, AND OCTOCRYLENESHISEIDO AMERICAS CORPORATIONf3729d0b-e601-48bb-9907-1d6e3ab319962026-02-17WarningsExact identifier
unii: 4Y5P7MUD51

Reported adverse events (FAERS/openFDA)#

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