GUERLAIN SUPER AQUA-SERUM BB HYDRA BEAUTY BALM WITH SUNSCREEN BROAD SPECTRUM SPF 25 LIGHT - octinoxate 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.

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GUERLAIN SUPER AQUA-SERUM BB HYDRA + BEAUTY BALM WITH SUNSCREEN BROAD SPECTRUM SPF 25 LIGHT

GUERLAIN SUPER AQUA-SERUM BB HYDRA + BEAUTY BALM WITH SUNSCREEN BROAD SPECTRUM SPF 25 LIGHT


Active ingredients

Octinoxate 7.49%
Titanium Dioxide 3.84%

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 of age: Ask a doctor

Inactive ingredients

AQUA (WATER) - GLYCERIN - BUTYLENE GLYCOL - SQUALANE - PROPANEDIOL - PHENYL TRIMETHICONE - ETHYLHEXYL ISONONANOATE - SILICA - GLYCERYL STEARATE SE - PEG-60 HYDROGENATED CASTOR OIL - PENTYLENE GLYCOL - PHENOXYETHANOL - AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER - STEARYL ALCOHOL - DICAPRYLYL ETHER - STEARIC ACID - PARFUM (FRAGRANCE) - HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER - PHOSPHOLIPIDS - SODIUM HYALURONATE - TOCOPHERYL ACETATE - HYDROLYZED MILLET - ALUMINA - XYLOSE - SODIUM CITRATE - POLYGLYCERYL-10 STEARATE - DISODIUM EDTA - RUSCUS ACULEATUS ROOT EXTRACT - POLYSORBATE 50 - VIOLA TRICOLOR EXTRACT - CITRONELLOL - CITRIC ACID - BHT - GERANIOL - BUTYLPHENYL METHYLPROPIONAL - HEXYL CINNAMAL - BENZYL SALICYLATE - LINALOOL - ETHYLHEXYLGLYCERIN - TOCOPHEROL - [MAY CONTAIN: CI 77891 (TITANIUM DIOXIDE) - CI 77492, CI 77491, CI 77499 (IRON OXIDES)] (08038)

Other information

  • Protects this product from excessive heat and direct sun.

Question or comments?

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

GUERLAIN SUPER AQUA-SERUM BB HYDRA + BEAUTY BALM WITH SUNSCREEN BROAD SPECTRUM SPF 25 LIGHT

Tube Label LIGHTOuter Label LIGHT

GUERLAIN SUPER AQUA-SERUM BB HYDRA BEAUTY BALM WITH SUNSCREEN BROAD SPECTRUM SPF 25 LIGHT 
octinoxate, titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:49817-0078
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE74.9 mg  in 1 mL
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE38.4 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
GLYCERIN 
BUTYLENE GLYCOL 
SQUALANE 
PROPANEDIOL 
PHENYL TRIMETHICONE 
ETHYLHEXYL ISONONANOATE 
SILICON DIOXIDE 
GLYCERYL STEARATE SE 
PEG-60 HYDROGENATED CASTOR OIL 
PENTYLENE GLYCOL 
PHENOXYETHANOL 
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER 
STEARYL ALCOHOL 
DICAPRYLYL ETHER 
STEARIC ACID 
HYALURONATE SODIUM 
.ALPHA.-TOCOPHEROL ACETATE 
ALUMINUM OXIDE 
XYLOSE 
SODIUM CITRATE 
POLYGLYCERYL-10 STEARATE 
EDETATE DISODIUM 
RUSCUS ACULEATUS ROOT 
VIOLA TRICOLOR 
.BETA.-CITRONELLOL, (R)- 
CITRIC ACID MONOHYDRATE 
BUTYLATED HYDROXYTOLUENE 
GERANIOL 
BUTYLPHENYL METHYLPROPIONAL 
.ALPHA.-HEXYLCINNAMALDEHYDE 
BENZYL SALICYLATE 
LINALOOL, (+/-)- 
ETHYLHEXYLGLYCERIN 
TOCOPHEROL 
FERRIC OXIDE YELLOW 
FERRIC OXIDE RED 
FERROSOFERRIC OXIDE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49817-0078-11 in 1 CARTON
140 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35212/27/2013
Labeler - Guerlain S.A. (395158322)
Establishment
NameAddressID/FEIBusiness Operations
Guerlain S.A.395158322manufacture(49817-0078)

Revised: 12/2013
 
Guerlain S.A.