FDA.reportPublic FDA data

TITANIUM DIOXIDE

Manufacturer
LVMH Fragrance Brands
Effective date
2023-11-06
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:21:45

Label at a glance#

ProductMATISSIME VELVET Radiant Mat Fluid Foundation with Sunscreen Broad Spectrum SPF 20 Mat Beige 04
Active ingredientTITANIUM DIOXIDE
Label structure8 sections

Indications and uses

helps prevent sunburn if used as directed with other sun protection measures (see ), decreases the risk of skin cancer and early skin aging caused by the sun. Directions

Dosage and administration

Apply liberally 15 minutes before sun exposure. Reapply at least every 2 hours. Use a water resistant sunscreen if swimming or sweating. 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 of 15 or higher and other sun protection measures including: Sun Protection Measures. limit time in the sun, especially fro...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 3.16%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • helps prevent sunburn if used as directed with other sun protection measures (see ), decreases the risk of skin cancer and early skin aging caused by the sun. Directions

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • on damaged or broken skin

When using this product

OTC - WHEN USING SECTION

  • keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

OTC - STOP USE SECTION

rash occurs

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally 15 minutes before sun exposure.
  • Reapply at least every 2 hours.
  • Use a water resistant sunscreen if swimming or sweating.
  • 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 of 15 or higher and other sun protection measures including: Sun Protection Measures.
  • limit time in the sun, especially from 10 a.m. – 2 p.m.
  • wear long-sleeve shirts, pants, hats, and sunglasses
  • Children under 6 months of age: ask a doctor.

Other information

SPL UNCLASSIFIED SECTION

  • Protect the product in this container from excessive heat and direct sun.

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, methyl trimethicone, dimethicone, alcohol, PEG-9 polydimethylsiloxyethyl dimethicone, butylene glycol, silica, isododecane, acrylates/dimethicone copolymer, phenyl trimethicone, phenoxyethanol, stearic acid, alumina, sodium myristoyl glutamate, disteardimonium hectorite, fragrance, tetrasodium EDTA, propylene carbonate, aluminum hydroxide, sanguisorba officinalis root extract, sodium metabisulfite, cinnamomum cassia bark extract, geraniol, nigella sativa seed oil, zingiber officinale (ginger) root extract, BHT, tocopherol. May Contain: titanium dioxide, iron oxides.

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-855-424-8563 Monday-Friday 9am to 5pm EST us.customerservice@lvmhfragrancebrands.com

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label4Label4BeigeBeigeBottleBottle

Products#

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

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
60905-060360905-0603-1, 60905-0603-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
METHYL TRIMETHICONES73ZQI0GXMIACT
DIMETHICONE92RU3N3Y1OIACT
ALCOHOL3K9958V90MIACT
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONETYP81E471FIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
ISODODECANEA8289P68Y2IACT
PHENYL TRIMETHICONEDR0K5NOJ4RIACT
PHENOXYETHANOLHIE492ZZ3TIACT
STEARIC ACID4ELV7Z65APIACT
ALUMINUM OXIDELMI26O6933IACT
SODIUM MYRISTOYL GLUTAMATEAYU7QD893WIACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
EDETATE SODIUMMP1J8420LUIACT
PROPYLENE CARBONATE8D08K3S51EIACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
SANGUISORBA OFFICINALIS ROOT4NYV2HT01XIACT
SODIUM METABISULFITE4VON5FNS3CIACT
CHINESE CINNAMONWS4CQ062KMIACT
GERANIOLL837108USYIACT
NIGELLA SATIVA SEED OILCS4U38E731IACT
GINGERC5529G5JPQIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
TOCOPHEROLR0ZB2556P8IACT
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
2527988c-03ca-80ba-e063-6394a90aa8ce42b255b2-aee4-316e-e054-00144ff8d46c2024-10-23WarningsExact identifier
spl set id: 42b255b2-aee4-316e-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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