FDA.reportPublic FDA data

TITANIUM DIOXIDE

Manufacturer
Guerlain
Effective date
2017-09-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:12:17

Label at a glance#

ProductTENUE DE PERFECTION TIMEPROOF FOUNDATION WITH SUNSCREEN ULTIMATE LASTING PERFECTION BROAD SPECTRUM SPF 20 01 BEIGE PALE
Active ingredientTITANIUM DIOXIDE
Label structure8 sections

Indications and uses

Helps prevent sunburn

Dosage and administration

For sunscreen use: Shake well before use. Apply liberally 15 minutes before sun exposure. Reapply at least 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 measure...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 2.92%

Purpose

OTC - PURPOSE SECTION

sunscreen

Uses

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn

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 

OTC - STOP USE SECTION

  • if rash occurs.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

For sunscreen use:

  • Shake well before use.
  • Apply liberally 15 minutes before sun exposure.
  • Reapply at least 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: Ask a doctor.

Inactive ingredients

INACTIVE INGREDIENT SECTION

AQUA (WATER) • METHYL TRIMETHICONE • DIMETHICONE • ISODODECANE • ALCOHOL • PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE • ACRYLATES/ DIMETHICONE COPOLYMER • SILICA • BUTYLENE GLYCOL • MICA • ALUMINUM HYDROXIDE • PHENOXYETHANOL • PHENYL TRIMETHICONE • DISTEARDIMONIUM HECTORITE • SODIUM MYRISTOYL GLUTAMATE • STEARIC ACID • GLYCERYL UNDECYL DIMETHICONE • VP/VA COPOLYMER • PROPYLENE CARBONATE • PARFUM (FRAGRANCE) • SODIUM CHLORIDE • TROMETHAMINE • BHT • BUTYLPHENYL METHYLPROPIONAL • LINALOOL • CITRONELLOL • ALPHA-ISOMETHYL IONONE • BENZYL BENZOATE • GERANIOL • [MAY CONTAIN: CI 77891 (TITANIUM DIOXIDE) • CI 77492, CI 77491, CI 77499 (IRON OXIDES)] (07856)

Other information

SPL UNCLASSIFIED SECTION

  • Protect this product from excessive heat and direct sun.

Question or comments?

OTC - QUESTIONS SECTION

In USA: 19 East, 57th Street, New York, NY 10022. 855 454 6242 Monday through Friday 9am to 5pm EST.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabelBottleBottleShadeShade

Products#

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

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49817-202449817-2024-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
METHYL TRIMETHICONES73ZQI0GXMIACT
DIMETHICONE92RU3N3Y1OIACT
ISODODECANEA8289P68Y2IACT
ALCOHOL3K9958V90MIACT
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONETYP81E471FIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
BUTYLENE GLYCOL3XUS85K0RAIACT
MICAV8A1AW0880IACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
PHENOXYETHANOLHIE492ZZ3TIACT
PHENYL TRIMETHICONEDR0K5NOJ4RIACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
SODIUM MYRISTOYL GLUTAMATEAYU7QD893WIACT
STEARIC ACID4ELV7Z65APIACT
COPOVIDONE K25-31D9C330MD8BIACT
PROPYLENE CARBONATE8D08K3S51EIACT
SODIUM CHLORIDE451W47IQ8XIACT
TROMETHAMINE023C2WHX2VIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
BUTYLPHENYL METHYLPROPIONALT7540GJV69IACT
LINALOOL, (+/-)-D81QY6I88EIACT
CITRONELLOL ACETATE, (R)-9X45FJL446IACT
ISOMETHYL-.ALPHA.-IONONE9XP4LC555BIACT
BENZYL BENZOATEN863NB338GIACT
GERANIOLL837108USYIACT
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
ed2a7f56-fb85-9e65-e053-2a95a90a9bd012e2c905-172d-4834-b18b-960df2d70d412022-11-10WarningsExact identifier
spl set id: 12e2c905-172d-4834-b18b-960df2d70d41

Reported adverse events (FAERS/openFDA)#

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