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 10 of 132 · 2,622 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pollen HayfeverADRENALINUM, ALLIUM CEPA, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM IODATUM, MUGWORT POLLEN (ARTEMISIA VULGARIS), BELLIS PERENNIS, BRASSICA SPP, CHENOPODIUM ALBUM, EUPHRASIA OFFICINALIS, HISTAMINUM HYDROCHLORICUM, ALFALFA POLLEN (MEDICAGO SATIVA), PHLEUM PRATENSE, YELLOW DOCK POLLEN (RUMEX CRISPUS), SABADILLA, SILICEA, GOLDENROD POLLEN (SOLIDAGO CANADENSIS), DANDELION POLLEN (TARAXACUM OFFICINALE), RED CLOVER POLLEN (TRIFOLIUM PRATENSE), XANTHIUM STRUMARIUMNaturalCare00665933-176e-4f16-b6ee-b55217b8abb32026-05-05WarningsExact identifier
unii: ETJ7Z6XBU4
LUMINOUS EYE CORRECTOR SPF 41 - FAIRTITANIUM DIOXIDE, ZINC OXIDEDrmtlgy, LLC8cfb1f8c-1bd7-4983-ab82-1c9bd8925afa2026-05-04WarningsExact identifier
unii: 15FIX9V2JP
LUMINOUS EYE CORRECTOR SPF 41 - DEEPTITANIUM DIOXIDE, ZINC OXIDEDrmtlgy, LLC930bd1de-5a0e-4607-8d3c-b1ca918f890b2026-05-04WarningsExact identifier
unii: 15FIX9V2JP
LUMINOUS EYE CORRECTOR SPF 41 - MEDIUMTITANIUM DIOXIDE, ZINC OXIDEDrmtlgy, LLC0206c676-c24d-470e-adb2-7cb3173f37272026-05-04WarningsExact identifier
unii: 15FIX9V2JP
LUMINOUS EYE CORRECTOR SPF 41 - TANTITANIUM DIOXIDE, ZINC OXIDEDrmtlgy, LLC5c5aad09-9f93-4634-8db1-c67570b38b2b2026-05-04WarningsExact identifier
unii: 15FIX9V2JP
Blue Lizard Sport SPF 50 SunscreenOCTISALATE AND TITANIUM DIOXIDE AND ZINC OXIDECrown Laboratories4955fa1c-789d-4f42-af75-70223310644a2026-05-01WarningsExact identifier
unii: 15FIX9V2JP
Blue Lizard Kids SPF 50 SunscreenOCTISALATE AND TITANIUM DIOXIDE AND ZINC OXIDECrown Laboratoriesba4ae906-48c0-8384-e053-2995a90afb912026-05-01WarningsExact identifier
unii: 15FIX9V2JP
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 2CR Cool RosyOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior6831832a-e52e-43ea-899f-f5d44bea5a942026-04-30WarningsExact identifier
unii: 15FIX9V2JP
Tru Skin Rituals SPF 25TITANIUM DIOXIDE, ZINC OXIDESpa de Soleilf725cd5c-999e-2393-e053-6394a90a09dc2026-04-30WarningsExact identifier
unii: 15FIX9V2JP
Hydrate ICOFFEA TOSTA, GINKGO BILOBA, GERMANIUM SESQUIOXIDE, SILICEABioActive Nutritional, Inc.c0c8d350-0257-4484-acd8-f852350173db2026-04-30WarningsExact identifier
unii: ETJ7Z6XBU4
TiZO2TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals Ltd.509cad98-0321-2a0a-e063-6294a90a6ea92026-04-29WarningsExact identifier
unii: 15FIX9V2JP
TiZO2TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals Ltd.509d7206-0cc1-c997-e063-6294a90a89e02026-04-29WarningsExact identifier
unii: 15FIX9V2JP
JMSOLUTION SKIN BOOST NIACINAMIDE SUNSCREENHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDEGPNY CORP211dea04-faad-8ffc-e063-6294a90a8d682026-04-29WarningsExact identifier
unii: 15FIX9V2JP
Anything SPFOCTINOXATE, OCTISALATE, ZINC OXIDE, AVOBENZONE, HOMOSALATE, TITANIUM DIOXIDEAnything SPF LLC508b8dcb-6600-6dad-e063-6294a90a565a2026-04-28WarningsExact identifier
unii: 15FIX9V2JP
HAUTE PROTECTION High Protection Tinted Compact Broad Spectrum SPF 50 BeigeTITANIUM DIOXIDE, ZINC OXIDEPierre Fabre USA Inc.8aabdd19-4975-06d2-e053-2995a90a50222026-04-24WarningsExact identifier
unii: 15FIX9V2JP
Johnsons Baby Mineral Sunscreen SPF 30TITANIUM DIOXIDE, ZINC OXIDEKenvue Brands LLC4fe04c4b-2751-0561-e063-6394a90af7682026-04-22WarningsExact identifier
unii: 15FIX9V2JP
Lazy Face SPF 30 FacescreenTITANIUM DIOXIDE, ZINC OXIDESunny Day Creations500ee303-7302-68d5-e063-6394a90ac6d42026-04-22WarningsExact identifier
unii: 15FIX9V2JP
ELROEL Pang Pang Sun Cushion S7ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATEMONOGLOT HOLDINGS Inc.256bf56f-aefa-47ce-890c-5a3896c11b922026-04-17WarningsExact identifier
unii: 15FIX9V2JP
JUNGSAEMMOOL Essential Skin Nuder Cushion FairTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEJungsaemmool Beauty Co., Ltd.3a43c7c0-7468-4b7a-95b9-f03e37f1b49b2026-04-17WarningsExact identifier
unii: 15FIX9V2JP
JUNGSAEMMOOL Essential Skin Nuder Cushion Fair LightTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEJungsaemmool Beauty Co., Ltd.a251eb20-02e6-4b55-b969-c1bef2f9d7322026-04-17WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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