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 57 of 131 · 2,608 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bare Barrier SportTITANIUM DIOXIDE, ZINC OXIDESkin Apeel, Inc.3c580794-eda3-de57-e063-6294a90a03032025-12-08WarningsExact identifier
unii: 15FIX9V2JP
Flawless Brightening SunscreenTITANIUM DIOXIDE, ZINC OXIDEFlawless Skin Care LLC312e9ca0-a388-a546-e063-6294a90a15d62025-12-08WarningsExact identifier
unii: 15FIX9V2JP
Mineral SPF 40, protectTITANIUM DIOXIDE, ZINC OXIDEAcne Specialists LLC2f8859cf-8277-6ea9-e063-6294a90a1a752025-12-08WarningsExact identifier
unii: 15FIX9V2JP
Mineral SPF 40, TintedTITANIUM DIOXIDE, ZINC OXIDEAcne Specialists LLC2fb19ed7-8cee-ce80-e063-6394a90ad3dc2025-12-08WarningsExact identifier
unii: 15FIX9V2JP
Mineral SPF 40, TintedTITANIUM DIOXIDE, ZINC OXIDEAcne Specialists LLC2fb14c4f-a435-aa6e-e063-6394a90a7d8d2025-12-08WarningsExact identifier
unii: 15FIX9V2JP
Mineral Sunscreen SPF 40 Non-TintedTITANIUM DIOXIDE, ZINC OXIDESkin Restoration Aesthetics2fc4f701-eea2-7913-e063-6294a90a86932025-12-08WarningsExact identifier
unii: 15FIX9V2JP
Mineral Sunscreen SPF 40 TintedTITANIUM DIOXIDE, ZINC OXIDESkin Restoration Aesthetics2fc55e8c-41d6-15cc-e063-6394a90ac5432025-12-08WarningsExact identifier
unii: 15FIX9V2JP
Daily Tinted Mineral SPFTITANIUM DIOXIDE, ZINC OXIDESkin Restoration Aesthetics2fc6e168-b2c1-bf9d-e063-6394a90aade72025-12-08WarningsExact identifier
unii: 15FIX9V2JP
UV Shade tinted matte mineral SPF 40TITANIUM DIOXIDE, ZINC OXIDEJoyce Kelly Enterprises365b3a1e-8410-da06-e063-6294a90a462f2025-12-08Exact identifier
unii: 15FIX9V2JP
Solar Shield non-tinted matte mineral SPF 40TITANIUM DIOXIDE, ZINC OXIDEJoyce Kelly Enterprises365b68a0-0f89-0f43-e063-6294a90a5eee2025-12-08Exact identifier
unii: 15FIX9V2JP
Secale QuartzSECALE QUARTZUriel Pharmacy Inc.1e9f55d7-22d5-4412-ac35-b4400bdf29a02025-12-08WarningsExact identifier
unii: ETJ7Z6XBU4
Mineral Sunscreen tintedTITANIUM DIOXIDE, ZINC OXIDEFace 5, LLC3000a0a7-2b51-b832-e063-6294a90a4a082025-12-08WarningsExact identifier
unii: 15FIX9V2JP
Non-Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEFace 5, LLC3001028b-bb36-04ec-e063-6294a90a1e492025-12-08WarningsExact identifier
unii: 15FIX9V2JP
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEFace 5, LLC3001aa3a-cc8b-6ad4-e063-6394a90a223f2025-12-08WarningsExact identifier
unii: 15FIX9V2JP
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEFace 5, LLC300268ff-f9ef-1006-e063-6294a90a5fdf2025-12-08WarningsExact identifier
unii: 15FIX9V2JP
Clear Path Tinted Facial SunscreenTITANIUM DIOXIDE, ZINC OXIDELULUS SPA BOUTIQUE37657755-fa82-88a0-e063-6394a90ade472025-12-08Exact identifier
unii: 15FIX9V2JP
Tinted Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEDermacare376468ce-8d9b-b672-e063-6294a90a0bd12025-12-08Exact identifier
unii: 15FIX9V2JP
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEDermacare37643884-f186-fb54-e063-6394a90a450f2025-12-08Exact identifier
unii: 15FIX9V2JP
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEMelinda Menezes, M.D., Inc.34b8208b-7328-1891-e063-6294a90abdd92025-12-08Exact identifier
unii: 15FIX9V2JP
Protect Mineral Sunscreen Non-TintedTITANIUM DIOXIDE, ZINC OXIDEMelinda Menezes, M.D., Inc.34b8dedc-0575-9819-e063-6394a90afebf2025-12-08Exact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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