FDA.reportPublic FDA data

OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE

Manufacturer
Guerlain
Effective date
2017-09-11
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:12:17

Label at a glance#

ProductLINGERIE DE PEAU BB INVISIBLE SKIN-FUSION MULTI-PERFECTING MAKEUP WITH SUNSCREEN BROAD SPECTRUM SPF 30 BB 3 NATURAL
Active ingredientOCTINOXATE, OXYBENZONE, 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, regullarly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: Limit t...

Label contents#

Full prescribing information#

Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 3.74%

Oxybenzone 1.00% 

Titanium Dioxide 3.55%

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, regullarly 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 • BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE • C12-15 ALKYL BENZOATE • GLYCERIN • ISODODECANE • CETYL PEG/PPG-10/1 DIMETHICONE • BUTYLENE GLYCOL • NYLON 6/12 • ALCOHOL • BETAINE • MAGNESIUM SULFATE • PHENOXYETHANOL • DISTEARDIMONIUM HECTORITE • ALUMINUM STEARATE • SORBITAN SESQUIOLEATE • POLYHYDROXYSTEARIC ACID • SODIUM MYRISTOYL GLUTAMATE • CAPRYLYL GLYCOL • PARFUM (FRAGRANCE) • ALUMINA • PROPYLENE CARBONATE • ALUMINUM HYDROXIDE • ACRYLATES / DIMETHICONE COPOLYMER • BUTYLPHENYL METHYLPROPIONAL • HYALURONIC ACID • TOCOPHERYL ACETATE • LINALOOL • CITRONELLOL • BHT • ALPHA-ISOMETHYL IONONE • BENZYL BENZOATE • GERANIOL • SERICIN • LIMONENE • HYDROLYZED LINSEED EXTRACT • PENTAERYTHRITYL TETRADI- T-BUTYL HYDROXYHYDROCINNAMATE • CITRIC ACID • POTASSIUM SORBATE • [MAY CONTAIN: CI 77891 (TITANIUM DIOXIDE) • CI 77492, CI 77491, CI 77499 (IRON OXIDES)] (11566)

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

Label3Label3Label2Label2Shade6Shade6

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-133346470419346GTIN-13: 3346470419346
EAN-13: 3346470419346
GTIN storage (14 digits): 03346470419346		Shade6.jpg

Products#

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

DailyMed product names page 1 of 1 · 36 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49817-202949817-2029-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 34 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
METHYL TRIMETHICONES73ZQI0GXMIACT
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE75D21FL1PIIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
GLYCERINPDC6A3C0OXIACT
ISODODECANEA8289P68Y2IACT
BUTYLENE GLYCOL3XUS85K0RAIACT
ALCOHOL3K9958V90MIACT
BETAINE3SCV180C9WIACT
MAGNESIUM SULFATE, UNSPECIFIED FORMDE08037SABIACT
PHENOXYETHANOLHIE492ZZ3TIACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
ALUMINUM STEARATEU6XF9NP8HMIACT
SORBITAN SESQUIOLEATE0W8RRI5W5AIACT
SODIUM MYRISTOYL GLUTAMATEAYU7QD893WIACT
CAPRYLYL GLYCOL00YIU5438UIACT
ALUMINUM OXIDELMI26O6933IACT
PROPYLENE CARBONATE8D08K3S51EIACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
BUTYLPHENYL METHYLPROPIONALT7540GJV69IACT
HYALURONIC ACIDS270N0TRQYIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
LINALOOL, (+/-)-D81QY6I88EIACT
.BETA.-CITRONELLOL, (R)-P01OUT964KIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
ISOMETHYL-.ALPHA.-IONONE9XP4LC555BIACT
BENZYL BENZOATEN863NB338GIACT
GERANIOLL837108USYIACT
LIMONENE, (+)-GFD7C86Q1WIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
OCTINOXATE4Y5P7MUD51ACTIB
OXYBENZONE95OOS7VE0YACTIB
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
ed2ac6bb-fb83-18bf-e053-2995a90a234ff80bd4ad-0c87-4b0c-9973-e2d79023d0c32022-11-10WarningsExact identifier
spl set id: f80bd4ad-0c87-4b0c-9973-e2d79023d0c3

Reported adverse events (FAERS/openFDA)#

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