GUERLAIN SUPER AQUA-HANDS - octinoxate, oxybenzone and avobenzone 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-Hands Vente

Active Ingredients

OCTINOXATE (ETHYLHEXYL METHOXYCINNAMATE) 7.4 % -

OXYBENZONE (BENZOPHENONE-3) 2.5 % -

AVOBENZONE (BUTYL METHOXYDIBENZOYLMETHANE) 0.5 %

Other Ingredients

AQUA (WATER) - DICAPRYLYL CARBONATE - GLYCERIN - HYDROGENATED COCO-GLYCERIDES - BUTYLENE GLYCOL - PENTYLENE GLYCOL - GLYCERYL STEARATE - DIMETHICONE - STEARYL ALCOHOL - ETHYLHEXYL PALMITATE - CAPRYLIC/CAPRIC TRIGLYCERIDE - CETETH-20 - POLYGLYCERIN-3 - POLYMETHYL METHACRYLATE - ADENIUM OBESUM LEAF CELL EXTRACT - DIGLYCERIN - MYRISTYL MYRISTATE - STEARETH-25 - STEARETH-21 - CETYL ALCOHOL - PHENOXYETHANOL - SERINE - SODIUM PCA - PARFUM (FRAGRANCE) - ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER - TOCOPHERYL ACETATE - XANTHAN GUM - TROMETHAMINE - CASTANEA
SATIVA (CHESTNUT) SEED EXTRACT - DISODIUM EDTA - XYLOSE - SODIUM HYALURONATE - CITRONELLOL - GERANIOL - BUTYLPHENYL METHYLPROPIONAL - HEXYL CINNAMAL - BENZYL SALICYLATE - LINALOOL - FAGUS SYLVATICA BUD EXTRACT - GLYCYRRHIZA GLABRA (LICORICE) ROOT EXTRACT - BHT - DIACETYL BOLDINE - ETHYLHEXYLGLYCERIN - SANGUISORBA OFFICINALIS ROOT EXTRACT - LIMONENE - CITRAL

Warning

FOR EXTERNAL USE ONLY. AVOID CONTACT WITH EYES.

DISCONTINUE USE IF SIGNS OF IRRITATION APPEAR

KEEP OUT OF REACH OF CHILDREN.

GUERLAIN SUPER AQUA-HANDS
octinoxate, oxybenzone, avobenzone cream

Product Information
Product Type	HUMAN OTC DRUG LABEL	Item Code (Source)	NDC:49817-0022
Route of Administration	TOPICAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (OCTINOXATE)	OCTINOXATE	74 mg in 1 mL
OXYBENZONE (OXYBENZONE)	OXYBENZONE	25 mg in 1 mL
AVOBENZONE (AVOBENZONE)	AVOBENZONE	5 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER
DICAPRYLYL CARBONATE
GLYCERIN
BUTYLENE GLYCOL
PENTYLENE GLYCOL
GLYCERYL MONOSTEARATE
DIMETHICONE
STEARYL ALCOHOL
ETHYLHEXYL PALMITATE
MEDIUM-CHAIN TRIGLYCERIDES
CETETH-20
MYRISTYL MYRISTATE
STEARETH-21
CETYL ALCOHOL
PHENOXYETHANOL
SERINE
SODIUM PYRROLIDONE CARBOXYLATE
TROMETHAMINE
EDETATE DISODIUM
XYLOSE
HYALURONATE SODIUM
GERANIOL
BUTYLPHENYL METHYLPROPIONAL
.ALPHA.-HEXYLCINNAMALDEHYDE
BENZYL SALICYLATE
BUTYLATED HYDROXYTOLUENE
ETHYLHEXYLGLYCERIN
CITRAL

#	Item Code	Package Description
Packaging
1	NDC:49817-0022-1	75 mL in 1 TUBE
2	NDC:49817-0022-2	75 mL in 1 TUBE
3	NDC:49817-0022-3	200 mL in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	07/14/2010	04/09/2014

Labeler - Guerlain S.A. (395158322)

Name	Address	ID/FEI	Business Operations
Establishment
Guerlain S.A.		395158322	manufacture(49817-0022)

Revised: 4/2014

Document Id: 44358f38-75c1-4e7e-bf51-a31ba0b98be8

Set id: 24faba80-00d6-4efd-944c-5f0553c51c98

Version: 10

Effective Time: 20140409

Guerlain S.A.