FDA.reportPublic FDA data

OCTINOXATE, TITANIUM DIOXIDE

Manufacturer
Guerlain
Effective date
2017-05-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:16:22

Label at a glance#

ProductLINGERIE DE PEAU AQUA NUDE WATER-INFUSED PERFECTING FLUID INTENSE HYDRATION LONG-WEAR FOUNDATION WITH SUNSCREEN BROAD...
Active ingredientOCTINOXATE, TITANIUM DIOXIDE
Label structure7 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 3.99%

Titanium Dioxide 3.04%

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 10 a.m.-2 p.m.
  • Wear long-sleeved shirts, pants, hats, and sunglasses.
  • Children under 6 months: Ask a doctor.

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.

Inactive ingredients

INACTIVE INGREDIENT SECTION

CYCLOPENTASILOXANE • ISODODECANE • AQUA (WATER) • ALCOHOL • TRIMETHYLSILOXYSILICATE • PEG-9 POLYDIMETHYLSILOXYETHYL
DIMETHICONE • DIPHENYL DIMETHICONE/VINYL DIPHENYL DIMETHICONE/SILSESQUIOXANE CROSSPOLYMER • PHENYL TRIMETHICONE
• POLYSILICONE-11 • SYNTHETIC FLUORPHLOGOPITE • GLYCERIN • METHYL METHACRYLATE CROSSPOLYMER • SILICA • ECYLOXAZOLIDINONE • ALUMINUM HYDROXIDE • DISTEARDIMONIUM HECTORITE • PARFUM (FRAGRANCE) • ISOSTEARIC ACID • PHENOXYETHANOL • GLYCERYL UNDECYL DIMETHICONE • POLYHYDROXYSTEARIC ACID • SODIUM MYRISTOYL GLUTAMATE • PROPYLENE CARBONATE • STEARIC ACID • ALPHA-ISOMETHYL IONONE • DISODIUM EDTA • TETRASODIUM EDTA • HYDROGEN DIMETHICONE • BENZYL BENZOATE • MALVA SYLVESTRIS (MALLOW) EXTRACT • LINALOOL • BHT • BENZYL ALCOHOL • LIMONENE • AMYL CINNAMAL • GERANIOL • TOCOPHEROL • [ MAY CONTAIN : CI 77491, CI 77492, CI 77499 (IRON OXIDES) • CI 77891 (TITANIUM DIOXIDE)] (11594)

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabelBottleBottle02C tester label02C tester labelShades7Shades7

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-133346470423985GTIN-13: 3346470423985
EAN-13: 3346470423985
GTIN storage (14 digits): 03346470423985		Shades7.jpg
QR code linkQR Codeopn.to/a/LDP_Aqua_Nude_G042387Label.jpg

Products#

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

DailyMed product names page 1 of 1 · 33 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49817-202149817-2021-1, 49817-2021-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 31 matching rows.

Name, UNII, Kind table
NameUNIIKind
CYCLOMETHICONE 50THT5PCI0RIACT
ISODODECANEA8289P68Y2IACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONETYP81E471FIACT
PHENYL TRIMETHICONEDR0K5NOJ4RIACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
GLYCERINPDC6A3C0OXIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
DECYLOXAZOLIDINONE95K9FHM51VIACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
ISOSTEARIC ACIDX33R8U0062IACT
PHENOXYETHANOLHIE492ZZ3TIACT
SODIUM MYRISTOYL GLUTAMATEAYU7QD893WIACT
PROPYLENE CARBONATE8D08K3S51EIACT
STEARIC ACID4ELV7Z65APIACT
ISOMETHYL-.ALPHA.-IONONE9XP4LC555BIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
EDETATE SODIUMMP1J8420LUIACT
BENZYL BENZOATEN863NB338GIACT
MALVA SYLVESTRIS FLOWERING TOPX1U1U0N90JIACT
LINALOOL, (+/-)-D81QY6I88EIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
BENZYL ALCOHOLLKG8494WBHIACT
LIMONENE, (+)-GFD7C86Q1WIACT
.ALPHA.-AMYLCINNAMALDEHYDEWC51CA3418IACT
GERANIOLL837108USYIACT
TOCOPHEROLR0ZB2556P8IACT
OCTINOXATE4Y5P7MUD51ACTIB
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
ed2a4e0b-9cde-49e3-e053-2a95a90add834fa856aa-da46-50da-e054-00144ff8d46c2022-11-10WarningsExact identifier
spl set id: 4fa856aa-da46-50da-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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