FDA.reportPublic FDA data

NDC 40046-0072-01 - STUDIO FIX FLUID SPF 15 BROAD SPECTRUM

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
40046-0072
Requested NDC
40046-0072-01
Package NDCs from labels
40046-0072-1, 40046-0072-01
Manufacturer
MAKEUP ART COSMETICS | Estee Lauder Companies Inc. | Estee Lauder Cosmetics Ltd.
Effective date
2024-12-25
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
STUDIO FIX FLUID SPF 15 BROAD SPECTRUMMAKEUP ART COSMETICS | Estee Lauder Companies Inc. | Estee Lauder Cosmetics Ltd.2024-12-25HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
40046-0072-12022-08-04C16284748780-1e4f33bdf-a796-d8a0-e053-dadaa90a6e4eSTUDIO FIX FLUID SPF 15 BROAD SPECTRUM
40046-0072-12022-07-29C16284748780-1e4f33bdf-a796-d8a0-e053-dadaa90a6e4eSTUDIO FIX FLUID SPF 15 BROAD SPECTRUM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
40046-0072-1STUDIO FIX FLUID SPF 15 BROAD SPECTRUM30 mL in 1 BOTTLELIQUID3010
40046-0072-1STUDIO FIX FLUID SPF 15 BROAD SPECTRUM1 in 1 CARTONLIQUID110

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
40046-0072STUDIO FIX FLUID SPF 15 BROAD SPECTRUM (OCTINOXATE AND TITANIUM DIOXIDE) LIQUID [MAKEUP ART COSMETICS]10Current NDC, Legacy NDC, 2 package rows20241227_ff48435d-245a-4037-9afb-caee83c4c415.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD51STUDIO FIX FLUID SPF 15 BROAD SPECTRUM (OCTINOXATE AND TITANIUM DIOXIDE) LIQUID [MAKEUP ART COSMETICS]1
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JPSTUDIO FIX FLUID SPF 15 BROAD SPECTRUM (OCTINOXATE AND TITANIUM DIOXIDE) LIQUID [MAKEUP ART COSMETICS]1
OCTINOXATEACTIVE MOIETY4Y5P7MUD51STUDIO FIX FLUID SPF 15 BROAD SPECTRUM (OCTINOXATE AND TITANIUM DIOXIDE) LIQUID [MAKEUP ART COSMETICS]1
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JPSTUDIO FIX FLUID SPF 15 BROAD SPECTRUM (OCTINOXATE AND TITANIUM DIOXIDE) LIQUID [MAKEUP ART COSMETICS]1
.alpha.-tocopherol acetateINACTIVE INGREDIENT9E8X80D2L0STUDIO FIX FLUID SPF 15 BROAD SPECTRUM (OCTINOXATE AND TITANIUM DIOXIDE) LIQUID [MAKEUP ART COSMETICS]1
butylene glycolINACTIVE INGREDIENT3XUS85K0RASTUDIO FIX FLUID SPF 15 BROAD SPECTRUM (OCTINOXATE AND TITANIUM DIOXIDE) LIQUID [MAKEUP ART COSMETICS]1
chloroxylenolINACTIVE INGREDIENT0F32U78V2QSTUDIO FIX FLUID SPF 15 BROAD SPECTRUM (OCTINOXATE AND TITANIUM DIOXIDE) LIQUID [MAKEUP ART COSMETICS]1
chromic oxideINACTIVE INGREDIENTX5Z09SU859STUDIO FIX FLUID SPF 15 BROAD SPECTRUM (OCTINOXATE AND TITANIUM DIOXIDE) LIQUID [MAKEUP ART COSMETICS]1
cyclomethicone 5INACTIVE INGREDIENT0THT5PCI0RSTUDIO FIX FLUID SPF 15 BROAD SPECTRUM (OCTINOXATE AND TITANIUM DIOXIDE) LIQUID [MAKEUP ART COSMETICS]1
dimethiconeINACTIVE INGREDIENT92RU3N3Y1OSTUDIO FIX FLUID SPF 15 BROAD SPECTRUM (OCTINOXATE AND TITANIUM DIOXIDE) LIQUID [MAKEUP ART COSMETICS]1
dipropylene glycolINACTIVE INGREDIENTE107L85C40STUDIO FIX FLUID SPF 15 BROAD SPECTRUM (OCTINOXATE AND TITANIUM DIOXIDE) LIQUID [MAKEUP ART COSMETICS]1
disteardimonium hectoriteINACTIVE INGREDIENTX687XDK09LSTUDIO FIX FLUID SPF 15 BROAD SPECTRUM (OCTINOXATE AND TITANIUM DIOXIDE) LIQUID [MAKEUP ART COSMETICS]1
ferric oxide redINACTIVE INGREDIENT1K09F3G675STUDIO FIX FLUID SPF 15 BROAD SPECTRUM (OCTINOXATE AND TITANIUM DIOXIDE) LIQUID [MAKEUP ART COSMETICS]1
ferric oxide yellowINACTIVE INGREDIENTEX438O2MRTSTUDIO FIX FLUID SPF 15 BROAD SPECTRUM (OCTINOXATE AND TITANIUM DIOXIDE) LIQUID [MAKEUP ART COSMETICS]1
ferrosoferric oxideINACTIVE INGREDIENTXM0M87F357STUDIO FIX FLUID SPF 15 BROAD SPECTRUM (OCTINOXATE AND TITANIUM DIOXIDE) LIQUID [MAKEUP ART COSMETICS]1
hyaluronate sodiumINACTIVE INGREDIENTYSE9PPT4THSTUDIO FIX FLUID SPF 15 BROAD SPECTRUM (OCTINOXATE AND TITANIUM DIOXIDE) LIQUID [MAKEUP ART COSMETICS]1
laureth-7INACTIVE INGREDIENTZ95S6G8201STUDIO FIX FLUID SPF 15 BROAD SPECTRUM (OCTINOXATE AND TITANIUM DIOXIDE) LIQUID [MAKEUP ART COSMETICS]1
magnesium sulfateINACTIVE INGREDIENTDE08037SABSTUDIO FIX FLUID SPF 15 BROAD SPECTRUM (OCTINOXATE AND TITANIUM DIOXIDE) LIQUID [MAKEUP ART COSMETICS]1
peg/ppg-18/18 dimethiconeINACTIVE INGREDIENT9H0AO7T794STUDIO FIX FLUID SPF 15 BROAD SPECTRUM (OCTINOXATE AND TITANIUM DIOXIDE) LIQUID [MAKEUP ART COSMETICS]1
pentaerythritol tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate)INACTIVE INGREDIENT255PIF62MSSTUDIO FIX FLUID SPF 15 BROAD SPECTRUM (OCTINOXATE AND TITANIUM DIOXIDE) LIQUID [MAKEUP ART COSMETICS]1
phenoxyethanolINACTIVE INGREDIENTHIE492ZZ3TSTUDIO FIX FLUID SPF 15 BROAD SPECTRUM (OCTINOXATE AND TITANIUM DIOXIDE) LIQUID [MAKEUP ART COSMETICS]1
propylene carbonateINACTIVE INGREDIENT8D08K3S51ESTUDIO FIX FLUID SPF 15 BROAD SPECTRUM (OCTINOXATE AND TITANIUM DIOXIDE) LIQUID [MAKEUP ART COSMETICS]1
saccharina latissimaINACTIVE INGREDIENT68CMP2MB55STUDIO FIX FLUID SPF 15 BROAD SPECTRUM (OCTINOXATE AND TITANIUM DIOXIDE) LIQUID [MAKEUP ART COSMETICS]1
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4STUDIO FIX FLUID SPF 15 BROAD SPECTRUM (OCTINOXATE AND TITANIUM DIOXIDE) LIQUID [MAKEUP ART COSMETICS]1
sorbic acidINACTIVE INGREDIENTX045WJ989BSTUDIO FIX FLUID SPF 15 BROAD SPECTRUM (OCTINOXATE AND TITANIUM DIOXIDE) LIQUID [MAKEUP ART COSMETICS]1
sorbitan sesquioleateINACTIVE INGREDIENT0W8RRI5W5ASTUDIO FIX FLUID SPF 15 BROAD SPECTRUM (OCTINOXATE AND TITANIUM DIOXIDE) LIQUID [MAKEUP ART COSMETICS]1
tocopherolINACTIVE INGREDIENTR0ZB2556P8STUDIO FIX FLUID SPF 15 BROAD SPECTRUM (OCTINOXATE AND TITANIUM DIOXIDE) LIQUID [MAKEUP ART COSMETICS]1
triethoxycaprylylsilaneINACTIVE INGREDIENTLDC331P08ESTUDIO FIX FLUID SPF 15 BROAD SPECTRUM (OCTINOXATE AND TITANIUM DIOXIDE) LIQUID [MAKEUP ART COSMETICS]1
waterINACTIVE INGREDIENT059QF0KO0RSTUDIO FIX FLUID SPF 15 BROAD SPECTRUM (OCTINOXATE AND TITANIUM DIOXIDE) LIQUID [MAKEUP ART COSMETICS]1
xanthan gumINACTIVE INGREDIENTTTV12P4NEESTUDIO FIX FLUID SPF 15 BROAD SPECTRUM (OCTINOXATE AND TITANIUM DIOXIDE) LIQUID [MAKEUP ART COSMETICS]1

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 5 of 448 · 8,948 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Utu Broad Spectrum SPF 30 Moisturizing Body SunscreenZINC OXIDEUtu Co59938ace-c97c-d758-e063-6394a90a77e42026-08-28WarningsExact identifier
application number: M020
Utu Broad Spectrum SPF 30 Moisturizing Face Mineral Zinc Oxide Sunscreen UnscentedZINC OXIDEUtu Co5982e790-7cdb-c96c-e063-6394a90a02d42026-08-28WarningsExact identifier
application number: M020
Utu Hydrating Sun Balm Broad Spectrum SPF 50ZINC OXIDEUtu Co59d1d0ac-2444-d6f9-e063-6294a90ae80c2026-08-28WarningsExact identifier
application number: M020
Hello Bello Mineral Sunscreen SPF 50ZINC OXIDETopiderm, Inc.54f12764-5c37-4a05-bf96-209fedb93fd12026-08-28WarningsExact identifier
application number: M020
GERI-LANTA MAXIMUM STRENGTHALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEPreferred Pharmaceuticals Inc.3b049027-30ac-4c78-a4f1-8191f7ed45bf2026-08-27WarningsExact identifier
unii: 92RU3N3Y1O
ISNTREE HYALURONIC ACID DAILY SUNGELAVOBENZONE, HOMOSALATE, OCTISALATEISNTREE Inc.5a02c540-5b3b-9379-e063-6294a90a00f62026-08-27WarningsExact identifier
application number: M020
MedlineDIMETHICONEMedline Industries, LP0d964138-f68d-dbf5-e063-6294a90a83202026-08-27WarningsExact identifier
unii: 92RU3N3Y1O
MZANK SUNSCREEN DAILY ULTIMATE PROTECTION SPF50SUNSCREEN SPF50Guangzhou Meixi Biotechnology Co., Ltd.5a0b4bd2-f6ad-35dc-e063-6294a90a8a662026-08-27WarningsExact identifier
application number: M020
unii: 15FIX9V2JP
Extra Strength Gas ReliefSIMETHICONEShield Pharmaceuticals Corp534144be-fcaf-400d-b772-595c62ae6ea62026-08-27WarningsExact identifier
unii: 92RU3N3Y1O
Round Lab Holiday Heroes Gift SetAVOBENZONE, HOMOSALATE, OCTISALATESEORIN COMPANY Co., Ltd.5a0d3a85-caff-a90d-e063-6394a90ad0452026-08-27WarningsExact identifier
application number: M020
AntacidALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEGuardian Drug Company48ec50ab-f24b-367b-e063-6294a90ad7362026-08-27WarningsExact identifier
unii: 92RU3N3Y1O
anti diarrheal and anti gasLOPERAMIDE HYDROCHLORIDE, SIMETHICONECVS Pharmacy065699b5-217e-432f-a253-cea2d3f622332026-08-26WarningsExact identifier
unii: 92RU3N3Y1O
MELAO Hydrating Lightweight SunscreenAVOBENZONE,ENSULIZOLE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,TITANIUM DIOXIDEGuangdong Aimu Biological Technology Co., Ltd59eeaea1-d726-99f3-e063-6394a90aeea32026-08-26WarningsExact identifier
application number: M020
unii: 15FIX9V2JP
KUGIG ALOE FOAMING INTIMATE WASHINTIMATE CLEANSING FOAMHong Kong KangXing Centennial Management Limited59f4d398-1186-a168-e063-6294a90ab44b2026-08-26WarningsExact identifier
unii: 059QF0KO0R
REGULAR STRENGTH ANTACIDALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEKROGER COMPANYb9e61a03-e008-50ab-e053-2a95a90a32102026-08-26WarningsExact identifier
unii: 92RU3N3Y1O
MAXIMUM STRENGTH ANTACIDALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONECVS PHARMACYaf71e02d-e7c7-f925-e053-2995a90a08612026-08-26WarningsExact identifier
unii: 92RU3N3Y1O
Argentum QuartzARGENTUM QUARTZUriel Pharmacy Inc.765c8c8f-0727-45da-a77e-c3907a3d07932026-08-26WarningsExact identifier
unii: ETJ7Z6XBU4
Hero Force Shield Superlight Sunscreen SPF 30ZINC OXIDEChurch & Dwight Co., Inc.140268a9-adb9-4574-ad82-4a2e924dc8082026-08-26WarningsExact identifier
application number: M020
Calamine PlusCALAMINE, PRAMOXINE HYDROCHLORIDEKroger Company44fdd5a4-3cac-15e5-e063-6294a90adb522026-08-26WarningsExact identifier
unii: 1K09F3G675
Endometrium ArgentumENDOMETRIUM ARGENTUMUriel Pharmacy Incd2d1428a-c8b5-9529-e053-2995a90a23432026-08-26WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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