FDA.reportPublic FDA data

STUDIO FINISH CONCEALER BROAD SPECTRUM SPF 35

Product NDC
40046-0078
11-digit product format
400460078
Labeler code
40046
Product ID
40046-0078_297b3562-9194-ca92-e063-6394a90aedd9
Type
HUMAN OTC DRUG
Nonproprietary name
OCTINOXATE and TITANIUM DIOXIDE
Dosage form
PASTE
Route
TOPICAL
Labeler
MAKEUP ART COSMETICS
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-08-08
Substance
OCTINOXATE; TITANIUM DIOXIDE
Active strength
5; 2 g/100g; g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
STUDIO FINISH CONCEALER BROAD SPECTRUM SPF 35
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTINOXATE5 g/100g
TITANIUM DIOXIDE2 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4Y5P7MUD51Internal UNII lookup
15FIX9V2JPInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2d034810-7210-4ad4-be23-ec2100f8c2f1Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
40046-0078-12022-08-04C16284748780-1e4f33bdf-afba-d8a0-e053-dadaa90a6e4eSTUDIO FINISH CONCEALER BROAD SPECTRUM SPF 35
40046-0078-12022-07-29C16284748780-1e4f33bdf-afba-d8a0-e053-dadaa90a6e4eSTUDIO FINISH CONCEALER BROAD SPECTRUM SPF 35

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
40046-0078-1STUDIO FINISH CONCEALER BROAD SPECTRUM SPF 351 in 1 CARTONPASTE18
40046-0078-1STUDIO FINISH CONCEALER BROAD SPECTRUM SPF 357 g in 1 JARPASTE78

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
40046-0078STUDIO FINISH CONCEALER BROAD SPECTRUM SPF 35 (OCTINOXATE AND TITANIUM DIOXIDE) PASTE [MAKEUP ART COSMETICS]8Current NDC, Legacy NDC, 2 package rows20241219_2d034810-7210-4ad4-be23-ec2100f8c2f1.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 43 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
JAFRA SUN Body Sunscreen BROAD SPECTRUM SPF 50 WATER RESISTANT 40 MINUTESAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEDistribuidora Comercial Jafra, S.A. de C.V.12b64f66-0ec0-4dde-9446-4151ae001ae42026-04-15WarningsExact identifier
application number: M020
Tula 24-7 Moisture Plus SPF 30 Hydrating Day with Sunscreen Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, AND OCTISALATEPML NYC, LLC396dc7c7-a5e1-e1b2-e063-6294a90a75472026-04-15WarningsExact identifier
application number: M020
Sei Bella Tinted BB Moisturizing Cream115 NPML NYC, LLC316e8ac6-f8fa-7add-e063-6294a90a4f242026-04-15WarningsExact identifier
application number: M020
ZO Skin Health Daily Mineral Sunshade Broad-Spectrum Sunscreen SPF 45 (Light)TITANIUM DIOXIDE, ZINC OXIDEZO Skin Health Inc.4f8756bf-5b0d-5269-e063-6294a90ae6dc2026-04-15WarningsExact identifier
application number: M020
YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20 Cameo GlowYOUR NAME MINERAL SHEER TINTPML NYC, LLC316cd602-8af5-fbb6-e063-6294a90a287b2026-04-15WarningsExact identifier
application number: M020
Chanvida Broad Spectrum BB CreamCHANVIDA BROAD SPECTRUM BB CREAMGuangzhou Ariel Biotech Co., Ltd.4f8ade09-4f7a-80bd-e063-6394a90a08432026-04-15WarningsExact identifier
application number: M020
SKINTIFIC OUTDOOR SUN BROAD SPECTRUM SPF 50AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONEGold Inti Trade Corporation4f6dd01e-21ab-0aa3-e063-6394a90a51f82026-04-14WarningsExact identifier
application number: M020
TRACELESS MINERAL BROAD SPECTRUM SPF SUNSCREEN AND PRIMERTRACELESS MINERAL BROAD SPECTRUM SPF SUNSCREEN AND PRIMERBEAUTY PIE U.S.A. INC.fdefb670-510c-9f1f-e053-6394a90a6a162026-04-14WarningsExact identifier
application number: M020
DAILY SUPERGOOP DOSE BIORETINOL MINERAL SPF 40DAILY DOSE BIORETINOL MINERAL SPF 40PML NYC, LLC05574910-ddf9-b138-e063-6394a90adc8c2026-04-14WarningsExact identifier
application number: M020
ProtecTINT 20CHOMOSALATE, OCTISALATE, ZINC OXIDEPML NYC, LLC1bcc9f71-820f-eba2-e063-6394a90a33052026-04-14WarningsExact identifier
application number: M020
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30BRIGHTENING SKIN TINTPML NYC, LLCf4c0f2d9-3e2f-5358-e053-2995a90aeb842026-04-14WarningsExact identifier
application number: M020
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30BRIGHTENING SKIN TINTPML NYC, LLCf4c2a37d-f52d-2fb0-e053-2a95a90a9bfa2026-04-14WarningsExact identifier
application number: M020
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30BRIGHTENING SKIN TINTPML NYC, LLCf4c3b1ef-0eae-6ac7-e053-2a95a90ac1dc2026-04-14WarningsExact identifier
application number: M020
NATURIUM Dew-Glow Moisturizer SPF 50NATURIUM DEW-GLOW MOISTURIZER SPF 50PML NYC, LLC00c93b11-754e-701c-e063-6294a90a3b1d2026-04-14WarningsExact identifier
application number: M020
Naturium Dew Glow Tinted Moisturizer SPF50-mediumHOMOSALATE, OCTISALATE, AVOBENZONEPML NYC, LLC1c3489a6-5b98-2dc2-e063-6294a90a06952026-04-14WarningsExact identifier
application number: M020
BANANA BOATTITANIUM DIOXIDE,ZINC OXIDEEdgewell Personal Care Brands LLC4f5896a6-0639-5589-e063-6294a90a45a92026-04-13WarningsExact identifier
application number: M020
SKINTIFIC OUTDOOR SUN BROAD SPECTRUM SPF 50AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE,OXYBENZONELongway Technology(Guangzhou)Co.,Ltd.4f2c83e4-e656-f81e-e063-6394a90a4c682026-04-11WarningsExact identifier
application number: M020
TRUST MD SPF30 STEM CELL FACEOCTINOXATE OCTISALATE HOMOSALATE AVOBENZONE TITANIUM DIOXIDEGuangzhou Yapheon Health Industry Co., Ltd.4f2ca12c-bc6f-61b8-e063-6294a90a0d7e2026-04-11WarningsExact identifier
application number: M020
MIDHA Rice Daily Moisture Sun CreamAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEMIDHA Cosmetic Co.,Ltd.4b394107-7830-c2c6-e063-6294a90a07d92026-04-10WarningsExact identifier
application number: M020
Abib Dewy tinted sunscreen Glow tube DeepOCTISALATE, OCTOCRYLENE, ZINC OXIDEFOURCOMPANY CO., LTD.4f15d5ba-6396-56bf-e063-6394a90adb062026-04-10WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
40046-0078-1400460078011 JAR in 1 CARTON (40046-0078-1) / 7 g in 1 JAR1 jar2011-08-080000-00-00NoNoCurrent