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 2 of 448 · 8,948 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MedlineDIMETHICONEMedline Industries, LP5afb59b4-491c-45bb-e063-6294a90a0ae62026-09-08WarningsExact identifier
unii: 92RU3N3Y1O
Double-Duty Face MoisturizerMOSITURIZING SUNSCREENJack Black, LLC672be406-e3a1-47b4-8ef6-ee2b62baae962026-09-08WarningsExact identifier
application number: M020
unii: 4Y5P7MUD51
Intense Therapy Lip Balm Pineapple MintSUNSCREEN SKIN PROTECTANT LIP BALMJack Black, LLC0862534c-5f48-4f67-a3b8-0876a667556f2026-09-08WarningsExact identifier
application number: M020
unii: 4Y5P7MUD51
Intense Therapy Lip Balm SPF25, Shea Butter and Vitamin ELIP BALM SPF25Jack Black, LLC88e8752d-1fbf-4e28-b79d-7c05ecdce8422026-09-08WarningsExact identifier
application number: M020
unii: 4Y5P7MUD51
Jack Black Intense Lip Therapy SPF25, Natural Mint and Shea ButterLIP BALM SUNSCREENJack Black, LLCe8730127-2d8d-4b80-ab90-d2f136d9e5162026-09-08WarningsExact identifier
application number: M020
unii: 4Y5P7MUD51
Jack Black Intense Therapy Lip Balm SPF25, Grapefruit and GingerLIP BALM SUNSCREENJack Black, LLCd961d22a-2125-41e9-94a3-5b53d12b320f2026-09-08WarningsExact identifier
application number: M020
unii: 4Y5P7MUD51
Jack Black Intense Lip Therapy SPF25, Black Tea and BlackberryLIP BALM SUNSCREENJack Black, LLC172a70bc-8a09-4258-b9bf-cf3c67ff76132026-09-08WarningsExact identifier
unii: 4Y5P7MUD51
Intense Therapy Lip Balm Asian PearSUNSCREEN SKIN PROTECTANT LIP BALMJack Black, LLCacace707-6671-4818-86f2-d9813792157a2026-09-08WarningsExact identifier
application number: M020
unii: 4Y5P7MUD51
Intense Therapy Lip Balm Basil LemonSUNSCREEN SKIN PROTECTANT LIP BALMJack Black, LLC277cb44d-608a-4ffc-a2a5-ac57d33d214c2026-09-08WarningsExact identifier
application number: M020
unii: 4Y5P7MUD51
Intense Therapy Lip Balm Black CherrySUNSCREEN SKIN PROTECTANT LIP BALMJack Black, LLC8f413bd6-258c-4c3c-89d1-369938c857202026-09-08WarningsExact identifier
application number: M020
unii: 4Y5P7MUD51
Intense Therapy Lip Balm Cucumber LimeSUNSCREEN SKIN PROTECTANT LIP BALMJack Black, LLC5f15bee9-9bf4-4f27-a6b5-4205deb625f62026-09-08WarningsExact identifier
application number: M020
unii: 4Y5P7MUD51
Intense Therapy Lip Balm Winter MelonSUNSCREEN SKIN PROTECTANT LIP BALMJack Black, LLCe7792b4e-a6d2-487e-ba28-27b68e6d7e272026-09-08WarningsExact identifier
application number: M020
unii: 4Y5P7MUD51
Jack Black Intense Therapy Lip Balm Vanilla BourbonAVOBENZONE, OCTINOXATE LIP BALM SUNSCREENJack Black, LLC517040d1-e6ed-40ca-a46f-2f75403dbc3c2026-09-08WarningsExact identifier
application number: M020
unii: 4Y5P7MUD51
Intense Therapy Lip Balm Mango and MandarinSUNSCREEN SKIN PROTECTANT LIP BALMJack Black, LLC8c55d1cd-cdd6-468b-8a17-b940c62101162026-09-08WarningsExact identifier
application number: M020
unii: 4Y5P7MUD51
Jack Black Intensive Therapy Lip Balm Mango Chili LimeAVOBENZONE, OCTINOXATE LIP BALM SUNSCREENJack Black, LLC51349d57-b14d-4798-8d68-03fbe3713d1e2026-09-08WarningsExact identifier
application number: M020
unii: 4Y5P7MUD51
Jack Black Sun Guard Sunscreen SPF45SUNSCREENJack Black, LLC3cc86bb2-05ce-47eb-8c71-f4f116ca58402026-09-08WarningsExact identifier
application number: M020
unii: 4Y5P7MUD51
Jack Black Intense Thearpy Lip Balm SPF25, Lemon and Shea ButterLIP BALM SUNSCREENJack Black, LLC518cb17a-fdaa-4a60-93fc-708305366eb82026-09-08WarningsExact identifier
application number: M020
unii: 4Y5P7MUD51
Jack Black Lavender Lip Balm 0.25ozLIP BALM SUNSCREENJack Black, L.L.C.e8c6a6d9-1093-41f1-87d5-faf8583d43192026-09-08WarningsExact identifier
application number: M020
unii: 4Y5P7MUD51
SPF15 lip balm 01OCTOCRYLENE, OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.f8695305-b89d-c21c-e053-6394a90a0e842026-09-08WarningsExact identifier
application number: M020
Sunscreen stickAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECosmuses Cosmetics (Ningbo) Co., Ltd.e9f963ee-a98c-efc1-e053-2a95a90aaf532026-09-08WarningsExact identifier
application number: M020

Reported adverse events (FAERS/openFDA)#

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