FDA.reportPublic FDA data

OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE

Manufacturer
Guerlain
Effective date
2018-02-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:02:52

Label at a glance#

ProductORCHIDEE IMPERIALE BRIGHTENING EXCEPTIONAL COMPLETE CARE THE BRIGHTENING AND PERFECTING UV PROTECTOR WITH SUNSCREEN B...
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, 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 6.74%

Oxybenzone 2%

Titanium Dioxide 8.87%

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.

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.

Inactive ingredients

INACTIVE INGREDIENT SECTION

AQUA (WATER) ● C12-15 ALKYL BENZOATE ● BUTYLENE GLYCOL ● ISODODECANE ● GLYCERIN ● CI 77891 (TITANIUM DIOXIDE) ● SILICA ● VINYL DIMETHICONE/ METHICONE SILSESQUIOXANE CROSSPOLYMER ● CETYL PEG/PPG-10/1 DIMETHICONE ● ALUMINA ● ALUMINUM STEARATE ● POLYHYDROXYSTEARIC ACID ● MAGNESIUM SULFATE ● GASTRODIA ELATA ROOT EXTRACT ● PHALAENOPSIS AMABILIS EXTRACT ● DENDROBIUM NOBILE EXTRACT ● PHENOXYETHANOL ● PARFUM (FRAGRANCE) ● SORBITAN SESQUIOLEATE ● CI 77492 (IRON OXIDES) ● CAPRYLYL GLYCOL ● SYNTHETIC FLUORPHLOGOPITE ● DISTEARDIMONIUM HECTORITE ● SODIUM MYRISTOYL GLUTAMATE ● CI 77491 (IRON OXIDES) ● PROPYLENE CARBONATE ● ALUMINUM HYDROXIDE ● LINALOOL ● MORINGA PTERYGOSPERMA SEED EXTRACT ● CI 77499 (IRON OXIDES) ● BHT ● DISODIUM PHOSPHATE ● CITRONELLOL ● CITRIC ACID ● GERANIOL ● TROPAEOLUM MAJUS EXTRACT ● TIN OXIDE ● ALPHA-ISOMETHYL IONONE ● LIMONENE ● STEARIC ACID ● ETHYLHEXYLGLYCERIN ● PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE ● HEXAPEPTIDE-2 ● TOCOPHEROL 

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer PackageOuter PackageInner PackageInner PackageTubeTube

Products#

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

DailyMed product names page 1 of 1 · 40 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49817-800149817-8001-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 38 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
ISODODECANEA8289P68Y2IACT
GLYCERINPDC6A3C0OXIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER9NH1UDD2RRIACT
ALUMINUM OXIDELMI26O6933IACT
ALUMINUM STEARATEU6XF9NP8HMIACT
MAGNESIUM SULFATE, UNSPECIFIED FORMDE08037SABIACT
GASTRODIA ELATA TUBER08F85I5YAVIACT
PHENOXYETHANOLHIE492ZZ3TIACT
SORBITAN SESQUIOLEATE0W8RRI5W5AIACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
CAPRYLYL GLYCOL00YIU5438UIACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
SODIUM MYRISTOYL GLUTAMATEAYU7QD893WIACT
FERRIC OXIDE RED1K09F3G675IACT
PROPYLENE CARBONATE8D08K3S51EIACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
LINALOOL, (+/-)-D81QY6I88EIACT
MORINGA OLEIFERA SEEDTIX5482832IACT
FERROSOFERRIC OXIDEXM0M87F357IACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FIACT
.BETA.-CITRONELLOL, (R)-P01OUT964KIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
GERANIOLL837108USYIACT
TROPAEOLUM MAJUS9G6ZOS4L87IACT
STANNIC OXIDEKM7N50LOS6IACT
ISOMETHYL-.ALPHA.-IONONE9XP4LC555BIACT
LIMONENE, (+)-GFD7C86Q1WIACT
STEARIC ACID4ELV7Z65APIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE)255PIF62MSIACT
TOCOPHEROLR0ZB2556P8IACT
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
ed2d3fa8-1254-60d5-e053-2995a90a0d05ea644eab-904b-45b6-b597-65299b1297d02022-11-11WarningsExact identifier
spl set id: ea644eab-904b-45b6-b597-65299b1297d0

Reported adverse events (FAERS/openFDA)#

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