STUDIO SCULPT SPF 15 BROAD SPECTRUM FOUNDATION

Manufacturer
MAKEUP ART COSMETICS | Estee Lauder Companies Inc. | MANA PRODUCTS, INC
Effective date
2025-12-29
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
monthly-update
Hydrated at
2026-06-03 17:46:53

Label at a glance#

ProductSTUDIO SCULPT SPF 15 BROAD SPECTRUM FOUNDATION
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 7.00%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

water\aqua\eau, cyclopentasiloxane, glycerin, butylene glycol, octyldodecyl neopentanoate, peg/ppg-18/18 dimethicone, polymethylsilsesquioxane, isostearic acid, c4-24 alkyl dimethicone/divinyldimethicone crosspolymer, isononyl isononanoate, tamarindus indica seed extract, tocopherol, tocopheryl acetate, sodium hyaluronate, haberlea rhodopensis leaf extract, beta vulgaris (beet) root extract\beta vulgaris\extrait de racine de betterave, butyrospermum parkii (shea butter), yeast extract\faex\extrait de levure, quercus suber bark extract, phytantriol, dextrin palmitate, dextrin palmitate/ethylhexanoate, cellulose gum, tetrahexyldecyl ascorbate, xanthan gum, dimethicone, methicone, propylene carbonate, sodium chloride, palmitic acid, polyglyceryl-4 isostearate, cetyl peg/ppg-10/1 dimethicone, hexyl laurate, polymethyl methacrylate, octyldodecyl pca, disteardimonium hectorite, stearic acid, caprylyl glycol, dipropylene glycol, phenoxyethanol, aluminum stearate, hexylene glycol [+/- mica, titanium dioxide (ci 77891), iron oxides (ci 77491, ci 77492, ci 77499), chromium oxide greens (ci 77288)] <iln35219>

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 - 40 ML Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MAC

STUDIO SCULPT
SPF 15
FOUNDATION
BROAD SPECTRUM
SPF 15

40 ML/1.3 US FL OZ e

PRINCIPAL DISPLAY PANEL - 40 ML Tube Carton
PRINCIPAL DISPLAY PANEL - 40 ML Tube Carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
40046-0065-12022-08-04C16284748780-1e4f33bdf-b1e2-d8a0-e053-dadaa90a6e4eSTUDIO SCULPT SPF 15 BROAD SPECTRUM FOUNDATION
40046-0065-12022-07-29C16284748780-1e4f33bdf-b1e2-d8a0-e053-dadaa90a6e4eSTUDIO SCULPT SPF 15 BROAD SPECTRUM FOUNDATION

Products#

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

DailyMed product names page 1 of 2 · 42 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
40046-006540046-0065-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 40 matching rows.

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
471e2a4c-73e5-ea92-e063-6294a90aefcaab8f5c2b-9fd8-4cd6-b6de-deef7e4bd4d22025-12-29WarningsExact identifier
spl id: 471e2a4c-73e5-ea92-e063-6294a90aefca
spl set id: ab8f5c2b-9fd8-4cd6-b6de-deef7e4bd4d2

Reported adverse events (FAERS/openFDA)#

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