SH18 ULTRA HARMONIE CARROT BEAUTY - hydroquinone lotion 
International Beauty Exchange

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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Drug Facts

Hydroquinone 2%

Ethylhexyl Methoxycinnamate (Octyl Methoxycinnamate) 0.5%

For external use only

On children under 12 years of age unless directed by a doctor

Avoid contact with eyes.

Skin Lightener

For the gradual fading of dark (brownish) areas in the skin such as freckles, age and liver spots

Apply a small amount as a thin layer on the affected area twice daily, or use as directed by a doctor

If swallowed, get medical help or contact a Poison Control Center right away

WATER,GLYCERYL STEARATE CITRATE, CETOSTEARYL ALCOHOL, GLYCERIN, ISOPROPYL MYRISTATE, ALLANTOIN, ASCORBIC ACID, SODIUM METABISULFITE, .ALPHA.-TOCOPHEROL ACETATE, D- SODIUM LAURYL, SULFATE EDETATE, DISODIUM, METHYLPARABEN, PROPYLPARABEN, CHLOROCRESOL

image of product

SH18 ULTRA HARMONIE CARROT BEAUTY 
hydroquinone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66129-116
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE) HYDROQUINONE10 mL  in 500 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.5 mL  in 500 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
CARROT (UNII: L56Z1JK48B)  
ALLANTOIN (UNII: 344S277G0Z)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
CHLOROCRESOL (UNII: 36W53O7109)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66129-116-25500 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart358A01/01/2011
Labeler - International Beauty Exchange (966261273)
Establishment
NameAddressID/FEIBusiness Operations
JABONES PARDO SA462018250manufacture

Revised: 7/2011
Document Id: 658e0e73-6446-4ff7-9ef2-7e76adc78693
Set id: 318d8452-5ea8-4137-8743-80afe93fa489
Version: 1
Effective Time: 20110706
 
International Beauty Exchange