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 113 of 131 · 2,608 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PURE HAVEN BODY SPF 30TITANIUM DIOXIDE, ZINC OXIDEPure haven, LLC6f298fcd-8a97-8f66-e053-2991aa0adb102023-11-11WarningsExact identifier
unii: 15FIX9V2JP
Sunstation All-Natural SPF 30 SunscreenTITANIUM DIOXIDE, ZINC OXIDESunstation USA, LLC499d366a-a7f1-6070-e054-00144ff88e882023-11-11WarningsExact identifier
unii: 15FIX9V2JP
Pure Haven EssentialsTITANIUM DIOXIDE, ZINC OXIDEPure Haven LLC4bccc017-266d-11ce-e054-00144ff8d46c2023-11-11WarningsExact identifier
unii: 15FIX9V2JP
koa protect our ocean life OXYBENZONE FREE Broad Spectrum SPF 30 UVA UVB Protection SunscreenTITANIUM DIOXIDE, ZINC OXIDEKapa'ihi, Inc66e5eb1b-4ef0-459d-8428-b3e2f221bc852023-11-11WarningsExact identifier
unii: 15FIX9V2JP
YOU-V SPF-30 Broad Spectrum SunscreenTITANIUM DIOXIDE, ZINC OXIDEYouV, LLC290cd617-aa90-4f10-8a1d-d8954b9270042023-11-11WarningsExact identifier
unii: 15FIX9V2JP
OUTER REEF Reef Safe (WR) Broad Spectrum SPF 30TITANIUM DIOXIDECoral Reef Park Co., Inc.743f3d23-0f5c-4724-9f69-411c109506e12023-11-11WarningsExact identifier
unii: 15FIX9V2JP
ONCODERM Rx Mineral Sunscreen SPF-30TITANIUM DIOXIDE, ZINC OXIDEOncoderm, LLC9f16e832-067c-4ae8-bd7d-6f0dc0ad6fae2023-11-11WarningsExact identifier
unii: 15FIX9V2JP
PROJECT REEF Mineral Sunscreen SPF-50ZINC OXIDE, TITANIUM DIOXIDEProject Reef LLC87b9170c-956e-4aa2-9416-da00cca81b582023-11-11WarningsExact identifier
unii: 15FIX9V2JP
DERMAKA Broad Spectrum SPF-42 SunscreenTITANIUM DIOXIDE, ZINC OXIDEDERMAKA SKIN PRODUCTS32b892fd-c68f-4670-bbaa-0b3de57128492023-11-11WarningsExact identifier
unii: 15FIX9V2JP
WILMA SCHUMANN Moisture Protektiv Day Cream SPF-20OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDESKINMETICS INC4a719986-d1d0-4156-b803-04004b7215042023-11-11WarningsExact identifier
unii: 15FIX9V2JP
DERMAKA Broad Spectrum SPF-42 Sunscreen UntintedTITANIUM DIOXIDE, ZINC OXIDEDERMAKA SKIN PRODUCTS9aa24e1f-e338-4947-a437-554fb6b227a22023-11-11WarningsExact identifier
unii: 15FIX9V2JP
TRENDY JOHN SPF-32 Sheer Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDETRENDY JOHN LLC80dccecb-fbb3-4af6-9cb4-6acea733e9962023-11-11WarningsExact identifier
unii: 15FIX9V2JP
KOVR All-Natural SPF-30 Moisturizing Sunscreen for WomenTITANIUM DIOXIDE, ZINC OXIDEACTIVE LIFE INC0ddc3bb9-595e-4ebd-ad3e-df4d94fd34ed2023-11-11WarningsExact identifier
unii: 15FIX9V2JP
Personalized Day Moisturizer with SPFTITANIUM DIOXIDE, ZINC OXIDEProven Skincare3b6546ed-22ee-48e6-83cc-5cbadf5674992023-11-10WarningsExact identifier
unii: 15FIX9V2JP
Tropical Sands SPF-30 Broad Spectrum Sunscreen (Coconut)TITANIUM DIOXIDE, ZINC OXIDEElements Brands, Inc.4935f888-cd92-61d1-e054-00144ff8d46c2023-11-10WarningsExact identifier
unii: 15FIX9V2JP
Coral Safe SPF-30 Broad Spectrum SunscreenTITANIUM DIOXIDE, ZINC OXIDEElements Brands, Inc.4925a507-863f-1088-e054-00144ff8d46c2023-11-10WarningsExact identifier
unii: 15FIX9V2JP
CoralSafe Broad Spectrum SPF30TITANIUM DIOXIDE, ZINC OXIDEElements Brandse6e00896-b7e5-41c6-a72b-08e600758cf52023-11-10WarningsExact identifier
unii: 15FIX9V2JP
Coral Safe SPF-30 Broad Spectrum SunscreenTITANIUM DIOXIDE, ZINC OXIDEElements Brands, Inc.4925a3ad-6379-108a-e054-00144ff8d46c2023-11-10WarningsExact identifier
unii: 15FIX9V2JP
BELASOL Sun Cream Non-Tinted Moisturizing SPF 50TITANIUM DIOXIDE, ZINC OXIDEEK Clothing LLC dba Belasolfb677ad0-2791-44ec-9720-951471ec009a2023-11-09WarningsExact identifier
unii: 15FIX9V2JP
Shaklee Youth Age Defense Mineral Moisturizer SPF 30TITANIUM DIOXIDEShaklee Corporationf4888fdc-09f9-43de-8c81-5a0f5e767d4e2023-11-09WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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