GUERLAIN PARURE DE LUMIERE LIGHT-DIFFUSING FOUNDATION WITH SUNSCREEN MOISTURE INFUSION BROAD SPECTRUM SPF 25 01 BEIGE PALE - octinoxate and titanium dioxide liquid 
Guerlain S.A.

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.

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GUERLAIN PARURE DE LUMIERE LIGHT-DIFFUSING FOUNDATION WITH SUNSCREEN MOISTURE INFUSION BROAD SPECTRUM SPF 25 01 BEIGE PALE

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  01 BEIGE PALE

Product Labels

Inner PackageInner Package 2Outer PacakgeParure De Lumiere Tester

GUERLAIN PARURE DE LUMIERE LIGHT-DIFFUSING FOUNDATION WITH SUNSCREEN MOISTURE INFUSION BROAD SPECTRUM SPF 25 01 BEIGE PALE  
octinoxate, titanium dioxide liquid
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:49817-0046
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE54.9 mg  in 1 mL
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE23.7 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
ISODODECANE 
GLYCERIN 
HYDROGENATED POLYBUTENE (1300 MW) 
METHYL TRIMETHICONE 
PENTYLENE GLYCOL 
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE 
PHENOXYETHANOL 
CHONDRUS CRISPUS 
SILICON DIOXIDE 
DIMETHICONE 
PEG-10 DIMETHICONE (600 CST) 
STEARIC ACID 
SODIUM MYRISTOYL GLUTAMATE 
ALUMINUM OXIDE 
PROPYLENE CARBONATE 
ALUMINUM HYDROXIDE 
BUTYLPHENYL METHYLPROPIONAL 
LINALOOL, (+/-)- 
.BETA.-CITRONELLOL, (R)- 
BUTYLATED HYDROXYTOLUENE 
ISOMETHYL-.ALPHA.-IONONE 
BENZYL BENZOATE 
GERANIOL 
TROPAEOLUM MAJUS 
TOCOPHEROL 
CITRAL 
ETHYLHEXYLGLYCERIN 
FERRIC OXIDE YELLOW 
FERRIC OXIDE RED 
FERROSOFERRIC OXIDE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49817-0046-11 in 1 CARTON
130 mL in 1 BOTTLE
2NDC:49817-0046-21 in 1 CARTON
215 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35207/26/2012
Labeler - Guerlain S.A. (395158322)
Establishment
NameAddressID/FEIBusiness Operations
Guerlain S.A.395158322manufacture(49817-0046)
Establishment
NameAddressID/FEIBusiness Operations
SOCOPLAN276221405repack(49817-0046)

Revised: 7/2012
 
Guerlain S.A.