PARURE DE LUMIERE LIGHT-DIFFUSING FOUNDATION WITH SUNSCREEN MOISTURE INFUSION BROAD SPECTRUM SPF 25 13 ROSE NATUREL - octinoxate, titanium dioxide liquid 
Guerlain

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

PARURE DE LUMIERE LIGHT-DIFFUSING FOUNDATION WITH SUNSCREEN MOISTURE INFUSION BROAD SPECTRUM SPF 25 13 ROSE NATUREL

Drug Facts


Active ingredients

Octinoxate 5.49%
Titanium Dioxide 2.37%

Purpose

Sunscreen

Uses

  • Helps prevent sunburn

Warnings

  • For external use only.

Do not use

on damaged or broken skin.

When using this product

keep out of eyes.  Rinse with water to remove.

Stop use and ask a doctor

if rash occurs.

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Shake well before use

For sunscreen use:

  • Apply liberally 15 minutes before sun exposure.
  • Reapply at least every two hours.
  • Use 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

AQUA (WATER), ISODODECANE, GLYCERIN, HYDROGENATED POLYISOBUTENE, METHYL TRIMETHICONE, PENTYLENE GLYCOL, POLYGLYCERYL-6 POLYRICINOLEATE, DISTEARDIMONIUM HECTORITE, BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE, MARIS AQUA (SEA WATER), PHENOXYETHANOL, CHONDRUS CRISPUS (CARRAGEENAN), POLYGLYCERYL-2 ISOSTEARATE, SILICA, DIMETHICONE, CALCIUM SODIUM BOROSILICATE, PEG-10 DIMETHICONE, STEARIC ACID, SODIUM MYRISTOYL GLUTAMATE, PARFUM (FRAGRANCE), ALUMINA, SILICA SILYLATE, PROPYLENE CARBONATE, ALUMINUM HYDROXIDE, BUTYLPHENYL METHYLPROPIIONAL, LINALOOL, CITRONELLOL, BYHT, ALPHA0ISOMETHYL IONONE, BENZYL BENZOATE, GERANIOL, TROPAEOLUM MAJUS EXTRACT, TOCOPHEROL, LIMONENE, CITRAL, ETHYLHEXYLGLYCERIN, [MAY CONTAIN: CI 77891 (TITANIUM DIOXIDE), CI 77492, CI 77491, CI 77499(IRON OXIDES)]

Other information

  • Protect this product from excessive heat and direct sun.

Questions or comments?

In USA: 19 East, 57th Street, New York, NY 10022

GUERLAIN PARURE DE LUMIERE  LIGHT-DIFFUSING FOUNDATION WITH SUNSCREEN MOISTURE INFUSION  BROAD SPECTRUM SPF 25 30ml e 1 FL OZ  13 ROSE NATUREL

Product Labels

Inner PackageInner Package 2Outer PacakgeParure De Lumiere Tester

PARURE DE LUMIERE LIGHT-DIFFUSING FOUNDATION WITH SUNSCREEN MOISTURE INFUSION BROAD SPECTRUM SPF 25 13 ROSE NATUREL  
octinoxate, titanium dioxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49817-0052
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE54.9 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE23.7 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ISODODECANE (UNII: A8289P68Y2)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CHONDRUS CRISPUS (UNII: OQS23HUA1X)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SODIUM MYRISTOYL GLUTAMATE (UNII: AYU7QD893W)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
BENZYL BENZOATE (UNII: N863NB338G)  
GERANIOL (UNII: L837108USY)  
TROPAEOLUM MAJUS (UNII: 9G6ZOS4L87)  
TOCOPHEROL (UNII: R0ZB2556P8)  
CITRAL (UNII: T7EU0O9VPP)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49817-0052-11 in 1 CARTON04/10/201408/31/2016
130 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:49817-0052-21 in 1 CARTON04/10/201408/31/2016
215 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35204/10/201408/31/2016
Labeler - Guerlain (266623064)
Establishment
NameAddressID/FEIBusiness Operations
Guerlain266623064manufacture(49817-0052)
Establishment
NameAddressID/FEIBusiness Operations
SOCOPLAN276221405repack(49817-0052)

Revised: 1/2017
 
Guerlain