GUERLAIN LINGERIE DE PEAU BB INVISIBLE SKIN-FUSION MULTI-PERFECTING MAKEUP WITH SUNSCREEN BROAD SPECTRUM SPF 30 MEDIUM - octinoxate, oxybenzone and titanium dioxide cream 
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.

----------

GUERLAIN LINGERIE DE PEAU BB INVISIBLE SKIN-FUSION MULTI-PERFECTING MAKEUP WITH SUNSCREEN BROAD SPECTRUM SPF 30 MEDIUM

GUERLAIN LINGERIE DE PEAU BB INVISIBLE SKIN-FUSION MULTI-PERFECTING MAKEUP WITH SUNSCREEN BROAD SPECTRUM SPF 30 MEDIUM


Active ingredients

Octinoxate 3.74 %
Oxybenzone 1.00 %
Titanium Dioxide 3.55 %

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

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 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 • BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE • C12-15 ALKYL BENZOATE • GLYCERIN • ISODODECANE • CETYL PEG/PPG-10/1 DIMETHICONE • BUTYLENE GLYCOL • NYLON 6/12 • ALCOHOL • BETAINE • MAGNESIUM SULFATE • PHENOXYETHANOL • DISTEARDIMONIUM HECTORITE • ALUMINUM STEARATE • SORBITAN SESQUIOLEATE • POLYHYDROXYSTEARIC ACID • SODIUM MYRISTOYL GLUTAMATE • CAPRYLYL GLYCOL • PARFUM (FRAGRANCE) • ALUMINA • PROPYLENE CARBONATE • ALUMINUM HYDROXIDE • ACRYLATES/DIMETHICONE COPOLYMER • BUTYLPHENYL METHYLPROPIONAL • HYALURONIC ACID • TOCOPHERYL ACETATE • LINALOOL • CITRONELLOL • BHT • ALPHA-ISOMETHYL IONONE • BENZYL BENZOATE • GERANIOL • SERICIN • LIMONENE • HYDROLYZED LINSEED EXTRACT • CITRIC ACID • POTASSIUM SORBATE • [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.

Question or comments?

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

GUERLAIN LINGERIE DE PEAU BB INVISIBLE SKIN-FUSION MULTI-PERFECTING MAKEUP WITH SUNSCREEN BROAD SPECTRUM SPF 30 MEDIUM 40ml (49817-0081-1)

Inner Label MediumOuter Label Medium

GUERLAIN LINGERIE DE PEAU BB INVISIBLE SKIN-FUSION MULTI-PERFECTING MAKEUP WITH SUNSCREEN BROAD SPECTRUM SPF 30 MEDIUM 
octinoxate, oxybenzone, titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:49817-0081
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE37.4 mg  in 1 mL
OXYBENZONE (OXYBENZONE) OXYBENZONE10 mg  in 1 mL
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE35.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
METHYL TRIMETHICONE 
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE 
ALKYL (C12-15) BENZOATE 
GLYCERIN 
ISODODECANE 
BUTYLENE GLYCOL 
NYLON-12 
ALCOHOL 
BETAINE 
MAGNESIUM SULFATE 
PHENOXYETHANOL 
DISTEARDIMONIUM HECTORITE 
ALUMINUM STEARATE 
SORBITAN SESQUIOLEATE 
SODIUM MYRISTOYL GLUTAMATE 
CAPRYLYL GLYCOL 
ALUMINUM OXIDE 
PROPYLENE CARBONATE 
ALUMINUM HYDROXIDE 
BUTYLPHENYL METHYLPROPIONAL 
HYALURONIC ACID 
.ALPHA.-TOCOPHEROL ACETATE 
LINALOOL, (+/-)- 
.BETA.-CITRONELLOL, (R)- 
BUTYLATED HYDROXYTOLUENE 
ISOMETHYL-.ALPHA.-IONONE 
BENZYL BENZOATE 
GERANIOL 
CITRIC ACID MONOHYDRATE 
POTASSIUM SORBATE 
FERRIC OXIDE YELLOW 
FERRIC OXIDE RED 
FERROSOFERRIC OXIDE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49817-0081-11 in 1 CARTON
140 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/21/2014
Labeler - Guerlain S.A. (395158322)
Establishment
NameAddressID/FEIBusiness Operations
Guerlain S.A.395158322manufacture(49817-0081)

Revised: 1/2014
Document Id: 9c4aa5d5-9d30-4b07-8760-7579140f08f2
Set id: 8de29c55-cea3-42bf-9174-1284f043b6be
Version: 1
Effective Time: 20140122
 
Guerlain S.A.