PARURE DE LUMIERE LIGHT-DIFFUSING FOUNDATION WITH SUNSCREEN MOISTURE INFUSION BROAD SPECTRUM SPF 25 05 BEIGE FONCE

Dosage form: liquid
Ingredients: OCTINOXATE 54.9mg in 1mL, TITANIUM DIOXIDE 23.7mg in 1mL
Labeler: Guerlain S.A.
NDC Code: 49817-0050

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 05 BEIGE FONCE

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  05 BEIGE FONCE

Product Labels
PARURE DE LUMIERE LIGHT-DIFFUSING FOUNDATION WITH SUNSCREEN MOISTURE INFUSION BROAD SPECTRUM SPF 25 05 BEIGE FONCE  
octinoxate, titanium dioxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49817-0050
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 Description
1NDC:49817-0050-11 BOTTLE (BOTTLE) in 1 CARTON
130 mL in 1 BOTTLE
2NDC:49817-0050-21 BOTTLE (BOTTLE) in 1 CARTON
215 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35204/10/2014
Labeler - Guerlain S.A. (395158322)
Establishment
NameAddressID/FEIOperations
Guerlain S.A.395158322manufacture(49817-0050)
Establishment
NameAddressID/FEIOperations
SOCOPLAN276221405repack(49817-0050)

Revised: 04/2014
 
Guerlain S.A.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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