FDA.reportPublic FDA data

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 0C

Product NDC
49817-2080
11-digit product format
498172080
Labeler code
49817
Product ID
49817-2080_09afc875-1d5a-8325-e063-6294a90a5515
Type
HUMAN OTC DRUG
Nonproprietary name
OCTISALATE, TITANIUM DIOXIDE
Dosage form
EMULSION
Route
TOPICAL
Labeler
Guerlain
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-08-01
Substance
OCTISALATE; TITANIUM DIOXIDE
Active strength
35; 9.4 mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
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 0C
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTISALATE35 mg/mL
TITANIUM DIOXIDE9.4 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4X49Y0596W, 15FIX9V2JP

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814
d1c9d1af-bddd-448d-86f7-69052b7d5b47Product name120220627
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49817-2080-1PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 0C35 mL in 1 BOTTLEEMULSION352
49817-2080-3PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 0C20 mL in 1 BOTTLEEMULSION202

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49817-2080PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 0C (OCTISALATE, TITANIUM DIOXIDE) EMULSION [GUERLAIN]2Current NDC, 2 package rows20231109_0d75be99-7607-4964-bb6e-3c731644ab4e.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
49817-2080-14981720800135 mL in 1 BOTTLE (49817-2080-1) 35 ml2023-08-01NoNoHistorical
49817-2080-34981720800320 mL in 1 BOTTLE (49817-2080-3) 20 ml2023-08-01NoNoHistorical