FDA.reportPublic FDA data

OCTINOXATE, TITANIUM DIOXIDE

Manufacturer
Guerlain
Effective date
2016-04-18
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 01:27:28

Label at a glance#

ProductLINGERIE DE PEAU NATURAL PERFECTION FOUNDATION SKIN-FUSION TEXTURE WITH SUNSCREEN BROAD SPECTRUM SPF 20 05N FONCE DEEP
Active ingredientOCTINOXATE, TITANIUM DIOXIDE
Label structure8 sections

Indications and uses

Helps prevent sunburn

Dosage and administration

For sunscreen 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...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 3%

Titanium Dioxide 3.16%

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:

  • 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 10a.m.-2p.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, ALCOHOL, PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, PENTYLENE GLYCOL, PHENYL TRIMETHICONE, SILICA, ACRYLATES/DIMETHICONE COPOLYMER, ACRYLATES COPOLYMER, ALUMINUM HYDROXIDE, BUTYLENE GLYCOL DICAPRYLATE/DICA- PRATE, STEARIC ACID, SORBITAN SESQUIOLEATE, PHENOXYETHANOL, ALUMINA, SODIUM MYRISTOYL GLUTAMATE, HYDROXYETHYL CELLULOSE, LECITHIN, TETRASODIUM EDTA, PARFUM (FRAGRANCE), BUTYLPHENYL METHYLPROPIONAL, SERICIN, LINALOOL, BHT, CITRONELLOL, ALPHA-ISOMETHYL IONONE, HYDROLYZED LINSEED EXTRACT, CITRIC ACID, POTASSIUM SORBATE, [MAY CONTAIN:MICA, CI77891(TITANIUM DIOXIDE), CI 77491, CI 77492, CI77499 (IRON OXIDES)]

Other information

SPL UNCLASSIFIED SECTION

  • Protect this product from excessive heat and direct sun.

Questions 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

Outer LabelOuter LabelBottleBottleFonceFonce

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-133346470423244GTIN-13: 3346470423244
EAN-13: 3346470423244
GTIN storage (14 digits): 03346470423244		Fonce.jpg

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
49817-201249817-2012-1, 49817-2012-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
NameUNIIKind
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONETYP81E471FIACT
PENTYLENE GLYCOL50C1307PZGIACT
PHENYL TRIMETHICONEDR0K5NOJ4RIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE75D21FL1PIIACT
STEARIC ACID4ELV7Z65APIACT
SORBITAN SESQUIOLEATE0W8RRI5W5AIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ALUMINUM OXIDELMI26O6933IACT
SODIUM MYRISTOYL GLUTAMATEAYU7QD893WIACT
EDETATE SODIUMMP1J8420LUIACT
BUTYLPHENYL METHYLPROPIONALT7540GJV69IACT
LINALOOL, (+/-)-D81QY6I88EIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
.BETA.-CITRONELLOL, (R)-P01OUT964KIACT
ISOMETHYL-.ALPHA.-IONONE9XP4LC555BIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
OCTINOXATE4Y5P7MUD51ACTIB
TITANIUM DIOXIDE15FIX9V2JPACTIB
WATER059QF0KO0RIACT
METHYL TRIMETHICONES73ZQI0GXMIACT
DIMETHICONE92RU3N3Y1OIACT
ALCOHOL3K9958V90MIACT

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
ed1931f4-10e5-22c2-e053-2a95a90ac3faacd52276-1392-45c7-afeb-5d3a54ae0dfd2022-11-10WarningsExact identifier
spl set id: acd52276-1392-45c7-afeb-5d3a54ae0dfd

Reported adverse events (FAERS/openFDA)#

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