FDA.reportPublic FDA data

OCTISALATE, TITANIUM DIOXIDE

Manufacturer
Guerlain
Effective date
2023-11-08
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:59:37

Label at a glance#

ProductPARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY...
Active ingredientOCTISALATE, TITANIUM DIOXIDE
Label structure9 sections

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 t...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Ethylhexyl Salicylate 3.5%

Titanium dioxide 0.94%

Purpose

OTC - PURPOSE SECTION

sunscreen

Use

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 if

OTC - STOP USE SECTION

  • 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.

Inactive ingredients

INACTIVE INGREDIENT SECTION

WATER • METHYL TRIMETHICONE • ISODODECANE • ALCOHOL • SYNTHETIC FLUORPHLOGOPITE • BUTYLENE GLYCOL • PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE • GLYCERIN • ACRYLATES/POLYTRIMETHYLSILOXYMETHACRYLATE COPOLYMER • SILICA •
DIMETHICONE • ACRYLATES/DIMETHICONE COPOLYMER • DISTEARDIMONIUMHECTORITE • CETYL DIMETHICONE • FRAGRANCE • POLYGLYCERYL-10 DECAISOSTEARATE • SODIUM MYRISTOYL GLUTAMATE • ALPHA-GLUCAN OLIGOSACCHARIDE • BETAINE • PROPYLENE
CARBONATE • CHLORPHENESIN • POLYMNIA SONCHIFOLIA ROOT JUICE • PAEONIA LACTIFLORA ROOT EXTRACT • CALCIUM ALUMINUM BOROSILICATE • ALUMINUM HYDROXIDE • MALTODEXTRIN • TROMETHAMINE • ALUMINA • STEARIC ACID • TOCOPHEROL • PRUNUS CERASUS (BITTER CHERRY) FLOWER EXTRACT • LACTOBACILLUS • PAEONIA ALBIFLORA FLOWER EXTRACT • GOLD • TIN OXIDE • [MAY CONTAIN: TITANIUM DIOXIDE • IRON OXIDES] ( 16947)

Other information

SPL UNCLASSIFIED SECTION

  • Protect this product from excessive heat and direct sun.

Question?

OTC - QUESTIONS SECTION

855 454 6242 Monday through Friday 9am to 5pm EST.

Package Labeling:35ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

35ml Label35ml Label35ml Bottle35ml Bottle35ml Label535ml Label5

Package Labeling:20ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

20ml Bottle20ml Bottle3W Label20ml3W Label20ml

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814
d1c9d1af-bddd-448d-86f7-69052b7d5b47Product name120220627

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49817-2078-1PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 7N35 mL in 1 BOTTLEEMULSION352
49817-2078-3PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 7N20 mL in 1 BOTTLEEMULSION202

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49817-2078PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 7N (OCTISALATE, TITANIUM DIOXIDE) EMULSION [GUERLAIN]2Current NDC, 2 package rows20231109_bfa2b2be-958c-439f-b363-2623df2b8501.zip

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
49817-207849817-2078-1, 49817-2078-3

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
WATER059QF0KO0RIACT
METHYL TRIMETHICONES73ZQI0GXMIACT
ISODODECANEA8289P68Y2IACT
ALCOHOL3K9958V90MIACT
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDEYK3DC63Y5MIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONETYP81E471FIACT
GLYCERINPDC6A3C0OXIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
DIMETHICONE92RU3N3Y1OIACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
SODIUM MYRISTOYL GLUTAMATEAYU7QD893WIACT
.ALPHA.-GLUCAN OLIGOSACCHARIDES95658MI3WIACT
BETAINE3SCV180C9WIACT
PROPYLENE CARBONATE8D08K3S51EIACT
CHLORPHENESINI670DAL4SZIACT
SMALLANTHUS SONCHIFOLIUS ROOT JUICEM9S7HX36CTIACT
PAEONIA LACTIFLORA ROOT3Z3866YW6PIACT
CALCIUM ALUMINUM BOROSILICATE3JRB8A35M0IACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
MALTODEXTRIN7CVR7L4A2DIACT
TROMETHAMINE023C2WHX2VIACT
ALUMINUM OXIDELMI26O6933IACT
STEARIC ACID4ELV7Z65APIACT
TOCOPHEROLR0ZB2556P8IACT
PRUNUS CERASUS FLOWERFPL16RUD0UIACT
PAEONIA LACTIFLORA FLOWERR73687A534IACT
GOLD79Y1949PYOIACT
STANNIC OXIDEKM7N50LOS6IACT
OCTISALATE4X49Y0596WACTIB
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
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 7NOCTISALATE, TITANIUM DIOXIDEGuerlainbfa2b2be-958c-439f-b363-2623df2b85012023-11-08WarningsExact identifier
ndc (package): 49817-2078-3
ndc (package): 49817-2078-1
ndc (product): 49817-2078
ndc11 (package): 49817207803
ndc11 (package): 49817207801
spl id: 09aa1e48-455b-491b-e063-6394a90ab19a
spl set id: bfa2b2be-958c-439f-b363-2623df2b8501

Reported adverse events (FAERS/openFDA)#

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