LINGERIE DE PEAU INVISIBLE SKIN-FUSION FOUNDATION WITH SUNSCREEN BROAD SPECTRUM SPF 20 02 BEIGE CLAIR - octinoxate, 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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LINGERIE DE PEAU INVISIBLE SKIN-FUSION FOUNDATION WITH SUNSCREEN BROAD SPECTRUM SPF 20 02 BEIGE CLAIR

LINGERIE DE PEAU INVISIBLE SKIN-FUSION FOUNDATION WITH SUNSCREEN BROAD SPECTRUM SPF 20 02 BEIGE CLAIR


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

Inner Package

Outer Package

Sachet Label

Lingerie De Peau Tester

02_200ml

LINGERIE DE PEAU INVISIBLE SKIN-FUSION FOUNDATION WITH SUNSCREEN BROAD SPECTRUM SPF 20 02 BEIGE CLAIR  
octinoxate, titanium dioxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49817-0056
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE30 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE31.6 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ALCOHOL (UNII: 3K9958V90M)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
MICA (UNII: V8A1AW0880)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)  
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
SODIUM MYRISTOYL GLUTAMATE (UNII: AYU7QD893W)  
EDETATE SODIUM (UNII: MP1J8420LU)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
HYDROXYCITRONELLOL (UNII: R0B4U2I48W)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
SORBIC ACID (UNII: X045WJ989B)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49817-0056-11 in 1 CARTON04/10/201408/31/2016
130 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:49817-0056-61.5 mL in 1 PACKET; Type 0: Not a Combination Product04/10/201408/31/2016
3NDC:49817-0056-21 in 1 CARTON04/10/201408/31/2016
315 mL in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:49817-0056-3200 mL in 1 BOTTLE; Type 0: Not a Combination Product04/10/201407/06/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35204/10/201408/31/2016
Labeler - Guerlain S.A (266623064)
Establishment
NameAddressID/FEIBusiness Operations
Guerlain S.A266623064manufacture(49817-0056)
Establishment
NameAddressID/FEIBusiness Operations
SOCOPLAN276221405repack(49817-0056)

Revised: 1/2017
 
Guerlain S.A