FDA.reportPublic FDA data

NDC 61354-080-01 - 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
61354-080
Requested NDC
61354-080-01
Package NDCs from labels
61354-080-01, 61354-080-07, 61354-080-02, 61354-080-08, 61354-080-04, 61354-080-10, 61354-080-06, 61354-080-12
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
61354-080-072025-01-30f386c64a-014e-0266-e053-dadaa90a7c1aBare Minerals 5 in 1 BB advanced performance cream eyeshadow broad spectrum spf 15 - Barely Nude
61354-080-082025-01-30f386c649-e3c5-0266-e053-dadaa90a7c1aBare Minerals 5 in 1 BB advanced performance cream eyeshadow broad spectrum spf 15 - soft shell
61354-080-102025-01-30f386c649-b4b6-0266-e053-dadaa90a7c1aBare Minerals 5 in 1 BB advanced performance cream eyeshadow broad spectrum spf 15 - Candlelit Peach
61354-080-122025-01-30f386c649-bdfd-0266-e053-dadaa90a7c1aBare Minerals 5 in 1 BB advanced performance cream eyeshadow broad spectrum spf 15 - Exotic Lilac
61354-080-072023-02-10f386c64a-014e-0266-e053-dadaa90a7c1aBare Minerals 5 in 1 BB advanced performance cream eyeshadow broad spectrum spf 15 - Barely Nude
61354-080-082023-02-10f386c649-e3c5-0266-e053-dadaa90a7c1aBare Minerals 5 in 1 BB advanced performance cream eyeshadow broad spectrum spf 15 - soft shell
61354-080-102023-02-10f386c649-b4b6-0266-e053-dadaa90a7c1aBare Minerals 5 in 1 BB advanced performance cream eyeshadow broad spectrum spf 15 - Candlelit Peach
61354-080-122023-02-10f386c649-bdfd-0266-e053-dadaa90a7c1aBare Minerals 5 in 1 BB advanced performance cream eyeshadow broad spectrum spf 15 - Exotic Lilac
61354-080-072023-01-30f386c64a-014e-0266-e053-dadaa90a7c1aBare Minerals 5 in 1 BB advanced performance cream eyeshadow broad spectrum spf 15 - Barely Nude
61354-080-082023-01-30f386c649-e3c5-0266-e053-dadaa90a7c1aBare Minerals 5 in 1 BB advanced performance cream eyeshadow broad spectrum spf 15 - soft shell
61354-080-102023-01-30f386c649-b4b6-0266-e053-dadaa90a7c1aBare Minerals 5 in 1 BB advanced performance cream eyeshadow broad spectrum spf 15 - Candlelit Peach
61354-080-122023-01-30f386c649-bdfd-0266-e053-dadaa90a7c1aBare Minerals 5 in 1 BB advanced performance cream eyeshadow broad spectrum spf 15 - Exotic Lilac

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61354-080-01Cream3 mg in 1 BOTTLECREAM32
61354-080-02Cream3 mg in 1 BOTTLECREAM32
61354-080-04Cream3 mg in 1 BOTTLECREAM32
61354-080-06Cream3 mg in 1 BOTTLECREAM32
61354-080-07Cream1 in 1 CARTONCREAM12
61354-080-08Cream1 in 1 CARTONCREAM12
61354-080-10Cream1 in 1 CARTONCREAM12
61354-080-12Cream1 in 1 CARTONCREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61354-080CREAM (TITANIUM DIOXIDE) CREAM [OXYGEN DEVELOPMENT LLC]2Legacy NDC, 2 package rows20230211_bbeffa0a-2bc6-fea4-e053-2a95a90ac511.zip
61354-080CREAM (TITANIUM DIOXIDE) CREAM [OXYGEN DEVELOPMENT LLC]2Legacy NDC, 2 package rows20230211_bc07accc-5604-6c68-e053-2995a90a0a7e.zip
61354-080CREAM (TITANIUM DIOXIDE) CREAM [OXYGEN DEVELOPMENT LLC]2Legacy NDC, 2 package rows20230211_bc081c9a-7cc8-8b4e-e053-2995a90a8f92.zip
61354-080CREAM (TITANIUM DIOXIDE) CREAM [OXYGEN DEVELOPMENT LLC]2Legacy NDC, 2 package rows20230211_bc0734fd-6c6d-3c9c-e053-2995a90aa615.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 56 of 131 · 2,608 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tinted Primer Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDECECILIA EDWARDS3aff2074-1514-b5c5-e063-6394a90a75722025-12-09Exact identifier
unii: 15FIX9V2JP
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDELUNDQUIST INSTITUTE FOR BIOMEDICAL INNOVATION AT HARBOR-UCLA MEDICAL CENTER3729d270-64ac-4d2e-e063-6294a90aeb2c2025-12-09Exact identifier
unii: 15FIX9V2JP
Replenishing Tinted SunscreenTITANIUM DIOXIDE, ZINC OXIDEBeauty Journey Studio LLC3738a0c3-5c07-e49b-e063-6394a90a38e92025-12-09Exact identifier
unii: 15FIX9V2JP
Replenishing Non Tinted SunscreenTITANIUM DIOXIDE, ZINC OXIDEBeauty Journey Studio LLC37385fc6-1cde-8aa6-e063-6294a90a60172025-12-09Exact identifier
unii: 15FIX9V2JP
Skin Filter Matte SPFTITANIUM DIOXIDE, ZINC OXIDEMALORIE MILES3647f983-9e75-8955-e063-6294a90af1622025-12-08Exact identifier
unii: 15FIX9V2JP
Skin Filter Matte SPFTITANIUM DIOXIDE, ZINC OXIDEMALORIE MILES3649f758-e31b-3c6a-e063-6294a90a5c362025-12-08Exact identifier
unii: 15FIX9V2JP
Matte Shield SPFTITANIUM DIOXIDE, ZINC OXIDEACNE SOLUTIONS NYC INC3bb582ec-71e7-4ad8-e063-6394a90a94d42025-12-08WarningsExact identifier
unii: 15FIX9V2JP
Mineral Based Sunscreen Stick Non-TintedTITANIUM DIOXIDE, ZINC OXIDEKATHLEEN P. HUTTON, M.D., INC. A PROFESSIONAL CORPORATION3245561d-a90c-7bf0-e063-6394a90ab3b62025-12-08Exact identifier
unii: 15FIX9V2JP
Mineral Based Sunscreen Stick TintedTITANIUM DIOXIDE, ZINC OXIDEKATHLEEN P. HUTTON, M.D., INC. A PROFESSIONAL CORPORATION3245c1f7-2c1b-b6ad-e063-6394a90aaee62025-12-08Exact identifier
unii: 15FIX9V2JP
Mineral Based Foam Sunscreen TintedTITANIUM DIOXIDE, ZINC OXIDEKATHLEEN P. HUTTON, M.D., INC. A PROFESSIONAL CORPORATION32465271-abb9-d03f-e063-6294a90a990e2025-12-08Exact identifier
unii: 15FIX9V2JP
Mineral Based Foam Sunscreen Non-TintedTITANIUM DIOXIDE, ZINC OXIDEKATHLEEN P. HUTTON, M.D., INC. A PROFESSIONAL CORPORATION32486bfb-0cc8-0283-e063-6394a90a99672025-12-08Exact identifier
unii: 15FIX9V2JP
Healthy Mineral Sunscreen No Shine - No TintTITANIUM DIOXIDE, ZINC OXIDEZen Dermatology, Inc.31572a16-5f60-565f-e063-6394a90ab8c92025-12-08WarningsExact identifier
unii: 15FIX9V2JP
AcneFix Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEACNEFIX INC.315894b7-ac1b-0982-e063-6294a90ab8792025-12-08Exact identifier
unii: 15FIX9V2JP
Shunly Natural Cover SPF50TITANIUM DIOXIDE, ZINC OXIDEShunly Skin Carea64e373b-b3f6-4024-b5f5-253783485cd62025-12-08WarningsExact identifier
unii: 15FIX9V2JP
AcneFix Non-Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEACNEFIX INC.31583c7e-365a-d899-e063-6394a90aa63f2025-12-08Exact identifier
unii: 15FIX9V2JP
Mineral Fusion TintedTITANIUM DIOXIDE, ZINC OXIDEFOREFRONT DERMATOLOGY, S.C.334ec844-5560-50f7-e063-6394a90a01be2025-12-08Exact identifier
unii: 15FIX9V2JP
Mineral Fusion TintedTITANIUM DIOXIDE, ZINC OXIDEFOREFRONT DERMATOLOGY, S.C.334f90d6-68e5-db37-e063-6294a90a5fb12025-12-08Exact identifier
unii: 15FIX9V2JP
Silk ScreenTITANIUM DIOXIDE, ZINC OXIDESkin Apeel, Inc.3c44baf4-9555-faad-e063-6294a90ab24f2025-12-08WarningsExact identifier
unii: 15FIX9V2JP
Glow StickTITANIUM DIOXIDE, ZINC OXIDESkin Apeel, Inc.3c54b857-c017-a953-e063-6394a90a38df2025-12-08WarningsExact identifier
unii: 15FIX9V2JP
Lip ShieldTITANIUM DIOXIDE, ZINC OXIDESkin Apeel, Inc.3c545e55-3f55-842b-e063-6394a90ae48e2025-12-08WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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