STUDIO FIX FLUID SPF 15 BROAD SPECTRUM

Manufacturer
MAKEUP ART COSMETICS | Estee Lauder Companies Inc. | Estee Lauder Cosmetics Ltd.
Effective date
2024-12-25
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
full-release
Hydrated at
2026-06-01 00:48:48

Label at a glance#

ProductSTUDIO FIX FLUID SPF 15 BROAD SPECTRUM
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 2.50%Sunscreen
Titanium Dioxide 1.00%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

water/aqua/eau, cyclopentasiloxane, peg-10 dimethicone, butylene glycol, trimethylsiloxysilicate, dimethicone, magnesium sulfate, laminaria saccharina extract, algae extract, tocopheryl acetate, sodium hyaluronate, tocopherol, lecithin, hydrogenated lecithin, xanthan gum, sorbitan sesquioleate, methoxy amodimethicone/silsesquioxane copolymer, laureth-7, dipropylene glycol, dimethicone/peg-10/15 crosspolymer, dimethicone/peg-10 crosspolymer, peg/ppg-18/18 dimethicone, disteardimonium hectorite, silica, dimethicone crosspolymer, triethoxycaprylylsilane, propylene carbonate, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, sorbic acid, chloroxylenol, phenoxyethanol [+/- titanium dioxide (ci 77891), iron oxides (ci 77491, ci 77492, ci 77499), chromium oxide greens (ci 77288)] <iln36878>

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
LONDON W1K 3BQ / M6JC

PRINCIPAL DISPLAY PANEL - 30 ML Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display PanelPrincipal Display PanelM•A•C

STUDIO FIX FLUID

SPF 15

BROAD SPECTRUM SPF 15

30 ML/1.0 US FL OZ e

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
IngredientTypeUNIISPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD511
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JP1
OCTINOXATEACTIVE MOIETY4Y5P7MUD511
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JP1
.alpha.-tocopherol acetateINACTIVE INGREDIENT9E8X80D2L01
butylene glycolINACTIVE INGREDIENT3XUS85K0RA1
chloroxylenolINACTIVE INGREDIENT0F32U78V2Q1
chromic oxideINACTIVE INGREDIENTX5Z09SU8591
cyclomethicone 5INACTIVE INGREDIENT0THT5PCI0R1
dimethiconeINACTIVE INGREDIENT92RU3N3Y1O1
dipropylene glycolINACTIVE INGREDIENTE107L85C401
disteardimonium hectoriteINACTIVE INGREDIENTX687XDK09L1
ferric oxide redINACTIVE INGREDIENT1K09F3G6751
ferric oxide yellowINACTIVE INGREDIENTEX438O2MRT1
ferrosoferric oxideINACTIVE INGREDIENTXM0M87F3571
hyaluronate sodiumINACTIVE INGREDIENTYSE9PPT4TH1
laureth-7INACTIVE INGREDIENTZ95S6G82011
magnesium sulfateINACTIVE INGREDIENTDE08037SAB1
peg/ppg-18/18 dimethiconeINACTIVE INGREDIENT9H0AO7T7941
pentaerythritol tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate)INACTIVE INGREDIENT255PIF62MS1
phenoxyethanolINACTIVE INGREDIENTHIE492ZZ3T1
propylene carbonateINACTIVE INGREDIENT8D08K3S51E1
saccharina latissimaINACTIVE INGREDIENT68CMP2MB551
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU41
sorbic acidINACTIVE INGREDIENTX045WJ989B1
sorbitan sesquioleateINACTIVE INGREDIENT0W8RRI5W5A1
tocopherolINACTIVE INGREDIENTR0ZB2556P81
triethoxycaprylylsilaneINACTIVE INGREDIENTLDC331P08E1
waterINACTIVE INGREDIENT059QF0KO0R1
xanthan gumINACTIVE INGREDIENTTTV12P4NEE1

Products#

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

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
40046-007240046-0072-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 3 · 134 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
phenoxyethanolPHENOXYETHANOLHIE492ZZ3TAEROSOL / TOPICAL1.05 %w/wExact identifier — unii+route
12 equally ranked IID candidates
ferric oxide yellowFERRIC OXIDE YELLOWEX438O2MRTCAPSULE / ORAL14 mgExact identifier — unii candidate
40 equally ranked IID candidates
ferric oxide yellowFERRIC OXIDE YELLOWEX438O2MRTPOWDER, FOR SUSPENSION / ORAL3 mgExact identifier — unii candidate
40 equally ranked IID candidates
phenoxyethanolPHENOXYETHANOLHIE492ZZ3TAEROSOL, FOAM / TOPICAL72 mgExact identifier — unii+route
12 equally ranked IID candidates
cyclomethicone 5CYCLOMETHICONE 50THT5PCI0RAEROSOL, FOAM / TOPICAL144 mgExact identifier — unii+route
6 equally ranked IID candidates
sorbic acidSORBIC ACIDX045WJ989BCREAM / TOPICAL14 mgExact identifier — unii+route
10 equally ranked IID candidates
ferrosoferric oxideFERROSOFERRIC OXIDEXM0M87F357CAPSULE, COATED / ORAL0.11 mgExact identifier — unii candidate
20 equally ranked IID candidates
ferric oxide yellowFERRIC OXIDE YELLOWEX438O2MRTSUSPENSION / ORAL6 mgExact identifier — unii candidate
40 equally ranked IID candidates
xanthan gumXANTHAN GUMTTV12P4NEECREAM / TOPICAL46 mgExact identifier — unii+route
10 equally ranked IID candidates
ferric oxide yellowFERRIC OXIDE YELLOWEX438O2MRTTABLET / SUBLINGUAL1 mgExact identifier — unii candidate
40 equally ranked IID candidates
ferric oxide yellowFERRIC OXIDE YELLOWEX438O2MRTTABLET, DELAYED RELEASE / ORAL7 mgExact identifier — unii candidate
40 equally ranked IID candidates
ferric oxide yellowFERRIC OXIDE YELLOWEX438O2MRTCAPSULE, DELAYED RELEASE / ORAL3 mgExact identifier — unii candidate
40 equally ranked IID candidates
peg/ppg-18/18 dimethiconePEG/PPG-18/18 DIMETHICONE9H0AO7T794GEL / TOPICAL1 %w/wExact identifier — unii+route
2 equally ranked IID candidates
hyaluronate sodiumHYALURONATE SODIUMYSE9PPT4THGEL / TOPICAL463 mgExact identifier — unii+route
4 equally ranked IID candidates
.alpha.-tocopherol acetate.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0CAPSULE / ORAL2 mgExact identifier — unii candidate
6 equally ranked IID candidates
cyclomethicone 5CYCLOMETHICONE 50THT5PCI0RCREAM, AUGMENTED / TOPICAL260 mgExact identifier — unii+route
6 equally ranked IID candidates
ferric oxide yellowFERRIC OXIDE YELLOWEX438O2MRTTABLET / SUBLINGUAL1 mgExact identifier — unii candidate
40 equally ranked IID candidates
xanthan gumXANTHAN GUMTTV12P4NEELOTION / TOPICAL0.3 %w/vExact identifier — unii+route
10 equally ranked IID candidates
ferric oxide yellowFERRIC OXIDE YELLOWEX438O2MRTTABLET / BUCCAL1 mgExact identifier — unii candidate
40 equally ranked IID candidates
ferrosoferric oxideFERROSOFERRIC OXIDEXM0M87F357TABLET, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
20 equally ranked IID candidates
cyclomethicone 5CYCLOMETHICONE 50THT5PCI0RCREAM, AUGMENTED / TOPICAL260 mgExact identifier — unii+route
6 equally ranked IID candidates
ferric oxide yellowFERRIC OXIDE YELLOWEX438O2MRTTABLET / ORAL24 mgExact identifier — unii candidate
40 equally ranked IID candidates
ferric oxide yellowFERRIC OXIDE YELLOWEX438O2MRTTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL2 mgExact identifier — unii candidate
40 equally ranked IID candidates
ferrosoferric oxideFERROSOFERRIC OXIDEXM0M87F357CAPSULE, EXTENDED RELEASE / ORAL1.49 mgExact identifier — unii candidate
20 equally ranked IID candidates
phenoxyethanolPHENOXYETHANOLHIE492ZZ3TGEL / TOPICAL14 mgExact identifier — unii+route
12 equally ranked IID candidates
ferric oxide yellowFERRIC OXIDE YELLOWEX438O2MRTCAPSULE, COATED / ORAL0.01 mgExact identifier — unii candidate
40 equally ranked IID candidates
sorbic acidSORBIC ACIDX045WJ989BOINTMENT / TOPICAL0.1 %w/wExact identifier — unii+route
10 equally ranked IID candidates
butylene glycolBUTYLENE GLYCOL3XUS85K0RASYSTEM / TOPICAL1400 mgExact identifier — unii+route
2 equally ranked IID candidates
ferric oxide yellowFERRIC OXIDE YELLOWEX438O2MRTTABLET / BUCCAL1 mgExact identifier — unii candidate
40 equally ranked IID candidates
ferric oxide yellowFERRIC OXIDE YELLOWEX438O2MRTGRANULE, FOR SUSPENSION / ORAL11 mgExact identifier — unii candidate
40 equally ranked IID candidates
ferric oxide yellowFERRIC OXIDE YELLOWEX438O2MRTCAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
40 equally ranked IID candidates
ferric oxide yellowFERRIC OXIDE YELLOWEX438O2MRTFILM / BUCCAL0.27 mgExact identifier — unii candidate
40 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4GEL / TOPICAL6 mgExact identifier — unii+route
2 equally ranked IID candidates
ferric oxide redFERRIC OXIDE RED1K09F3G675LOTION / TOPICALNAExact identifier — unii+route
4 equally ranked IID candidates
sorbic acidSORBIC ACIDX045WJ989BOINTMENT / TOPICAL0.1 %w/wExact identifier — unii+route
10 equally ranked IID candidates
sorbic acidSORBIC ACIDX045WJ989BCREAM / TOPICAL14 mgExact identifier — unii+route
10 equally ranked IID candidates
ferric oxide yellowFERRIC OXIDE YELLOWEX438O2MRTCAPSULE, DELAYED RELEASE / ORAL3 mgExact identifier — unii candidate
40 equally ranked IID candidates
ferric oxide yellowFERRIC OXIDE YELLOWEX438O2MRTCAPSULE, EXTENDED RELEASE / ORAL7 mgExact identifier — unii candidate
40 equally ranked IID candidates
sorbitan sesquioleateSORBITAN SESQUIOLEATE0W8RRI5W5AOINTMENT / TOPICAL75 mgExact identifier — unii+route
2 equally ranked IID candidates
ferric oxide yellowFERRIC OXIDE YELLOWEX438O2MRTTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL2 mgExact identifier — unii candidate
40 equally ranked IID candidates
ferric oxide yellowFERRIC OXIDE YELLOWEX438O2MRTCAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
40 equally ranked IID candidates
sorbic acidSORBIC ACIDX045WJ989BAEROSOL, FOAM / TOPICAL6 mgExact identifier — unii+route
10 equally ranked IID candidates
ferric oxide redFERRIC OXIDE RED1K09F3G675CREAM / TOPICALNAExact identifier — unii+route
4 equally ranked IID candidates
ferric oxide yellowFERRIC OXIDE YELLOWEX438O2MRTTABLET, COATED / ORAL1 mgExact identifier — unii candidate
40 equally ranked IID candidates
ferrosoferric oxideFERROSOFERRIC OXIDEXM0M87F357POWDER, FOR SUSPENSION / ORALNAExact identifier — unii candidate
20 equally ranked IID candidates
xanthan gumXANTHAN GUMTTV12P4NEESUSPENSION / TOPICAL0.11 %w/vExact identifier — unii+route
10 equally ranked IID candidates
ferrosoferric oxideFERROSOFERRIC OXIDEXM0M87F357TABLET / ORAL2 mgExact identifier — unii candidate
20 equally ranked IID candidates
ferric oxide yellowFERRIC OXIDE YELLOWEX438O2MRTTABLET, COATED / ORAL1 mgExact identifier — unii candidate
40 equally ranked IID candidates
phenoxyethanolPHENOXYETHANOLHIE492ZZ3TCREAM / TOPICAL57 mgExact identifier — unii+route
12 equally ranked IID candidates
xanthan gumXANTHAN GUMTTV12P4NEEGEL / TOPICAL58 mgExact identifier — unii+route
10 equally ranked IID candidates
cyclomethicone 5CYCLOMETHICONE 50THT5PCI0RAEROSOL / TOPICAL2.5 %w/wExact identifier — unii+route
6 equally ranked IID candidates
xanthan gumXANTHAN GUMTTV12P4NEECREAM / TOPICAL46 mgExact identifier — unii+route
10 equally ranked IID candidates
ferric oxide yellowFERRIC OXIDE YELLOWEX438O2MRTTABLET, DELAYED RELEASE / ORAL7 mgExact identifier — unii candidate
40 equally ranked IID candidates
ferrosoferric oxideFERROSOFERRIC OXIDEXM0M87F357CAPSULE, DELAYED RELEASE / ORAL6 mgExact identifier — unii candidate
20 equally ranked IID candidates
dipropylene glycolDIPROPYLENE GLYCOLE107L85C40FILM, EXTENDED RELEASE / BUCCAL30 mgExact identifier — unii candidate
6 equally ranked IID candidates
ferrosoferric oxideFERROSOFERRIC OXIDEXM0M87F357TABLET, DELAYED RELEASE / ORAL6 mgExact identifier — unii candidate
20 equally ranked IID candidates
tocopherolTOCOPHEROLR0ZB2556P8CREAM / TOPICALNAExact identifier — unii+route
2 equally ranked IID candidates
ferrosoferric oxideFERROSOFERRIC OXIDEXM0M87F357TABLET, DELAYED RELEASE / ORAL6 mgExact identifier — unii candidate
20 equally ranked IID candidates
tocopherolTOCOPHEROLR0ZB2556P8CREAM / TOPICALNAExact identifier — unii+route
2 equally ranked IID candidates
ferric oxide yellowFERRIC OXIDE YELLOWEX438O2MRTTABLET / ORAL24 mgExact identifier — unii candidate
40 equally ranked IID candidates

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 FIX FLUID SPF 15 BROAD SPECTRUMOCTINOXATE AND TITANIUM DIOXIDEMAKEUP ART COSMETICSff48435d-245a-4037-9afb-caee83c4c4152024-12-25WarningsExact identifier
ndc (package): 40046-0072-1
ndc (product): 40046-0072
ndc11 (package): 40046007201
spl id: 2a15bb87-bf9d-336e-e063-6294a90a85f2
spl set id: ff48435d-245a-4037-9afb-caee83c4c415

Reported adverse events (FAERS/openFDA)#

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