FDA.reportPublic FDA data

STUDIO FINISH CONCEALER BROAD SPECTRUM SPF 35

Manufacturer
MAKEUP ART COSMETICS | Estee Lauder Companies Inc. | Estee Lauder Cosmetics Ltd.
Effective date
2024-12-17
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 00:44:10

Label at a glance#

ProductSTUDIO FINISH CONCEALER BROAD SPECTRUM SPF 35
Active ingredientOCTINOXATE, TITANIUM DIOXIDE
Label structure9 sections

Dosage and administration

For sunscreen use: apply liberally 15 minutes before sun exposure reapply every two hours use a water resistant sunscreen if swimming or sweating Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: limit time in the sun,...

Storage and handling

protect the product in this container from excessive heat and direct sun

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active IngredientsPurpose
Octinoxate 5.00%Sunscreen
Titanium Dioxide 2.00%Sunscreen

Use

INDICATIONS & USAGE SECTION

helps prevent sunburn

Warnings

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

OTC - WHEN USING SECTION

When using this product keep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

For sunscreen use:

  • apply liberally 15 minutes before sun exposure
  • reapply every two hours
  • use a water resistant sunscreen if swimming or sweating
  • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
    • limit time in the sun, especially from 10 a.m. - 2 p.m
    • wear long-sleeved shirts, pants, hats and sunglasses.
  • children under 6 months of age: ask a doctor

inactive ingredients

INACTIVE INGREDIENT SECTION

octyldodecanol, synthetic beeswax, copernicia cerifera (carnauba) wax, silica, hydrogenated polyisobutene, simmondsia chinensis (jojoba) seed oil, tocopherol, ascorbyl palmitate, polybutene, pvp/hexadecene copolymer, alumina, stearic acid [+/-(may contain) titanium dioxide (ci 77891), iron oxides (ci 77491, ci 77492, ci 77499), chromium oxide greens (ci 77288)] <iln28455>

Other information

STORAGE AND HANDLING SECTION

protect the product in this container from excessive heat and direct sun

SPL UNCLASSIFIED SECTION

DIST. BY: MAKE-UP ART COSMETICS
TORONTO, ONTARIO, CANADA M5V 1R7

PRINCIPAL DISPLAY PANEL - 7 g Jar Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

M•A•C

STUDIO FINISH
CONCEALER
SPF 35
BROAD SPECTRUM
SPF 35

NET WT. 7 g/.24 US OZ e

PRINCIPAL DISPLAY PANEL - 7 g Jar Carton
PRINCIPAL DISPLAY PANEL - 7 g Jar Carton

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

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
40046-007840046-0078-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
OCTYLDODECANOL461N1O614YIACT
CARNAUBA WAXR12CBM0EIZIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
HYDROGENATED POLYBUTENE (1300 MW)7D1YQ9Y5EZIACT
JOJOBA OIL724GKU717MIACT
TOCOPHEROLR0ZB2556P8IACT
ASCORBYL PALMITATEQN83US2B0NIACT
POLYBUTENE (1400 MW)1NA5AO9GH7IACT
ALUMINUM OXIDELMI26O6933IACT
STEARIC ACID4ELV7Z65APIACT
FERRIC OXIDE RED1K09F3G675IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
FERROSOFERRIC OXIDEXM0M87F357IACT
CHROMIC OXIDEX5Z09SU859IACT
OCTINOXATE4Y5P7MUD51ACTIB
TITANIUM DIOXIDE15FIX9V2JPACTIB

Source Document#

Source XML

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
STUDIO FINISH CONCEALER BROAD SPECTRUM SPF 35OCTINOXATE AND TITANIUM DIOXIDEMAKEUP ART COSMETICS2d034810-7210-4ad4-be23-ec2100f8c2f12024-12-17WarningsExact identifier
ndc (package): 40046-0078-1
ndc (product): 40046-0078
ndc11 (package): 40046007801
spl id: 297b3562-9194-ca92-e063-6394a90aedd9
spl set id: 2d034810-7210-4ad4-be23-ec2100f8c2f1

Reported adverse events (FAERS/openFDA)#

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