LINGERIE DE PEAU INVISIBLE SKIN-FUSION FOUNDATION WITH SUNSCREEN BROAD SPECTRUM SPF 20 13 ROSE NATUREL

Dosage form: liquid
Ingredients: OCTINOXATE 30mg in 1mL, TITANIUM DIOXIDE 31.6mg in 1mL
Labeler: Guerlain S.A
NDC Code: 49817-0061

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.

LINGERIE DE PEAU INVISIBLE SKIN-FUSION FOUNDATION WITH SUNSCREEN BROAD SPECTRUM SPF 20 13 ROSE NATUREL

LINGERIE DE PEAU INVISIBLE SKIN-FUSION FOUNDATION WITH SUNSCREEN BROAD SPECTRUM SPF 20 13 ROSE NATUREL


Active ingredients

Octinoxate  3.00%
Titanium Dioxide  3.16%

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 a water resistant sunscreen if swimming or sweating.
  • Sun protection measures.  Spending time in the sun increases your risk of skin cancer and early 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), METHYL TRIMETHICONE, DIMETHICONE, ALCOHOL, PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, PENTYLENE GLYCOL, MICA, PHENYL TRIMETHICONE, SILICA, ACRYLATES/DIMETHICONE COPOLYMER, ALUMINUM HYDROXIDE, BUTYLENE GLYCOL DICAPRYLATE/CAPRATE, STEARIC ACID, SORBITAN SESQUIOLEATE, PHENOXYETHANOL, ALUMINA, SODIUM MYRISTOYL GLUTAMATE, HYDROXYETHYLCELLULOSE, LECITHIN, TETRASODIUM EDTA, PARFUM(FRAGRANCE), HEXYL CINNAMAL, SERICIN, HYDROXYCITRONELLAL, BHT, CITRONELLOL, ALPHA-ISOMETHYL IONONE, HYDROLYZED LINSEED EXTRACT, SORBIC ACID, [MAY CONTAIN CI 77891(TITANIUM DIOXIDE), CI 77491, CI 77492, CI 77499 (IRON OXIDES)]

Other information
  • Protect this product from excessive heat and direct sun.

Question or comments?

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

Representative Labeling




LINGERIE DE PEAU INVISIBLE SKIN-FUSION FOUNDATION WITH SUNSCREEN BROAD SPECTRUM SPF 20 13 ROSE NATUREL  
octinoxate, titanium dioxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49817-0061
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE30 mg  in 1 mL
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE31.6 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
METHYL TRIMETHICONE 
DIMETHICONE 
ALCOHOL 
PENTYLENE GLYCOL 
MICA 
PHENYL TRIMETHICONE 
SILICON DIOXIDE 
ALUMINUM HYDROXIDE 
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE 
SORBITAN SESQUIOLEATE 
PHENOXYETHANOL 
ALUMINUM OXIDE 
SODIUM MYRISTOYL GLUTAMATE 
EDETATE SODIUM 
.ALPHA.-HEXYLCINNAMALDEHYDE 
HYDROXYCITRONELLOL 
BUTYLATED HYDROXYTOLUENE 
.BETA.-CITRONELLOL, (R)- 
ISOMETHYL-.ALPHA.-IONONE 
SORBIC ACID 
FERRIC OXIDE RED 
FERRIC OXIDE YELLOW 
FERROSOFERRIC OXIDE 
Packaging
#Item CodePackage Description
1NDC:49817-0061-11 BOTTLE (BOTTLE) in 1 CARTON
130 mL in 1 BOTTLE
2NDC:49817-0061-21 BOTTLE (BOTTLE) in 1 CARTON
215 mL in 1 BOTTLE
3NDC:49817-0061-3200 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.A395158322manufacture(49817-0061)
Establishment
NameAddressID/FEIOperations
SOCOPLAN276221405repack(49817-0061)

Revised: 06/2014
 
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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