GUERLAIN SUPER AQUA-DAY - octinoxate, oxybenzone, titanium dioxide, octocrylene and sulisobenzone 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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Guerlain Super Aqua-Day

Active Ingredients

OCTINOXATE (ETHYLHEXYL METHOXYCINNAMATE) 7.4 % - OXYBENZONE (BENZOPHENONE-3) 3.0 % - TITANIUM DIOXIDE 2.4 % - OCTOCRYLENE 2.0 % - SULISOBENZONE (BENZOPHENONE-4) 0.5 %.


Warning

FOR EXTERNAL USE ONLY. AVOID CONTACT WITH EYES.

DISCONTINUE USE IF SIGNS OF IRRITATION APPEAR.


KEEP OUT OF REACH OF CHILDREN.


Other Ingredients

AQUA (WATER) - DICAPRYLYL CARBONATE - GLYCERIN - C12-15 ALKYL BENZOATE - PENTYLENE GLYCOL - BUTYLENE GLYCOL - CETEARYL ALCOHOL - GLYCERYL STEARATE - ALUMINUM STARCH OCTENYLSUCCINATE - CETYL ALCOHOL - DECYLOXAZOLIDINONE - PEG-100 STEARATE - STEARYL ALCOHOL - PARFUM (FRAGRANCE) - ADENIUM OBESUM LEAF CELL EXTRACT - SODIUM POLYACRYLATE - PHENOXYETHANOL - DIMETHICONE - SERINE - ALUMINUM STEARATE - POLYHYDROXYSTEARIC ACID - AMMONIUM ACRYLOYLDIMETHYL - TAURATE/VP COPOLYMER - CETETH-10 PHOSPHATE - DICETYL PHOSPHATE - TOCOPHERYL ACETATE - SODIUM PCA - TROMETHAMINE - CASTANEASATIVA (CHESTNUT) SEED EXTRACT - TETRASODIUM EDTA - XANTHAN GUM - ALUMINA - PALMITIC ACID - STEARIC ACID - XYLOSE - MALVA SYLVESTRIS (MALLOW) EXTRACT - CITRONELLOL - CENTELLA ASIATICA LEAF EXTRACT - SODIUM HYALURONATE - GERANIOL - BUTYLPHENYL METHYLPROPIONAL - HEXYL CINNAMAL - BENZYL SALICYLATE - BHT - LINALOOL - FAGUS SYLVATICA BUD EXTRACT - ETHYLHEXYLGLYCERIN - LIMONENE - SANGUISORBA OFFICEINALIS ROOT EXTRACT - CITRAL - BENZYL ALCOHOL - CYNNAMYL ALCOHOL 045480

Representative Labeling

Guerlain Super Aqua Day Outer

GuerlainSuperAquaDayInner

GUERLAIN SUPER AQUA-DAY  
octinoxate, oxybenzone, titanium dioxide, octocrylene, sulisobenzone liquid
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:49817-0021
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE74 mg  in 1 mL
OXYBENZONE (OXYBENZONE) OXYBENZONE30 mg  in 1 mL
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE24 mg  in 1 mL
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE20 mg  in 1 mL
SULISOBENZONE (SULISOBENZONE) SULISOBENZONE5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
DICAPRYLYL CARBONATE 
GLYCERIN 
C12-15 ALKYL BENZOATE 
PENTYLENE GLYCOL 
BUTYLENE GLYCOL 
CETOSTEARYL ALCOHOL 
GLYCERYL MONOSTEARATE 
ALUMINUM STARCH OCTENYLSUCCINATE 
CETYL ALCOHOL 
POLYOXYL 100 STEARATE 
STEARYL ALCOHOL 
PHENOXYETHANOL 
DIMETHICONE 
SERINE 
ALUMINUM STEARATE 
DIHEXADECYL PHOSPHATE 
SODIUM PYRROLIDONE CARBOXYLATE 
TROMETHAMINE 
EDETATE SODIUM 
XANTHAN GUM 
ALUMINUM OXIDE 
PALMITIC ACID 
STEARIC ACID 
XYLOSE 
HYALURONATE SODIUM 
GERANIOL 
BUTYLPHENYL METHYLPROPIONAL 
BENZYL SALICYLATE 
BUTYLATED HYDROXYTOLUENE 
ETHYLHEXYLGLYCERIN 
CITRAL 
BENZYL ALCOHOL 
LINALOOL, DL- 
.ALPHA.-HEXYLCINNAMALDEHYDE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49817-0021-140 mL in 1 BOTTLE
2NDC:49817-0021-240 mL in 1 BOTTLE
3NDC:49817-0021-350 mL in 1 BOTTLE
4NDC:49817-0021-42 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35206/17/201004/09/2014
Labeler - Guerlain S.A. (395158322)
Establishment
NameAddressID/FEIBusiness Operations
Guerlain S.A.395158322manufacture(49817-0021)

Revised: 4/2014
Document Id: f5a700f3-1de1-49e0-ad72-4ed9b2ed8545
Set id: 34ccc414-06f7-4073-8684-25498705c389
Version: 10
Effective Time: 20140409
 
Guerlain S.A.