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Name:Borba Age Defying Skin Lightening Spot Treatment
Manufacturer:Borba, Inc.
Category:Over-the-counter (OTC) Marketed Drugs


BORBA AGE DEFYING SKIN LIGHTENING SPOT TREATMENT

BORBA AGE DEFYING  SKIN LIGHTENING SPOT TREATMENT - hydroquinone lotion 
Borba, Inc.

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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BORBA
AGE DEFYING
SKIN LIGHTENING
SPOT TREATMENT

Drug Facts

Active ingredients

Hydroquinone 2%

Purpose

Skin lightener

Use

lightens dark (brownish) spots in the skin such as age and liver spots or freckles

Warnings

For external use only

When using this product

  • avoid contact with eyes
  • some users of this product may experience a mild skin irritation. If skin irritation becomes severe, stop use and consult a doctor.
  • do not use on children under 12 years of age unless directed by a doctor.

Stop use and ask a doctor if skin irritation becomes severe

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • adults: apply a small amount as a thin layer on the affected area twice daily, or use as directed by a doctor. If no improvement is seen after 3 months of treatment, use of this product should be discontinued.
  • lightening effect of this product may not be noticeable when used on very dark skin
  • children under 12 years of age: do not use unless directed by a doctor
  • sun exposure should be limited by using a sunscreen agent, a sun blocking agent, or protective clothing to cover bleached skin when using and after using this product in order to prevent darkening from reoccurring

Inactive ingredients

water, cetearyl ethylhexanoate, butylene glycol, glycerin, glyceryl stearate, cetyl alcohol, squalane, sclerotium gum, stearic acid, cetyl phosphate, cyclopentasiloxane, myrciaria dubia fruit extract, euterpe oleracea fruit extract, linum usitatissimum (linseed) seed extract, hydrolyzed elastin, argania spinosa kernel oil, sodium hyaluronate, panthenol, allantoin, butyrospermum parkii (shea) butter, dimethicone, tocopheryl acetate, sodium ascorbyl phosphate, ascorbic acid, calcium pantothenate, magnesium gluconate, niacinamide, pyridoxine HCl, retinyl palmitate, cyanocobalamin, zinc picolinate, dipotassium glycyrrhizate, bisabolol, biotin, ascorbyl palmitate, thioctic acid, lactic acid, citric acid, malic acid, camellia sinensis leaf extract, potassium azeloyl diglycinate, DMAE bitartrate, mannitol, polyisobutene, polysorbate 20, acrylamide/ammonium acrylate copolymer, aluminum hydroxide, methicone, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, salicylic acid, aminomethyl propanol, sodium sulfite, sodium bisulfite, methylparaben, chlorphenesin, phenoxyethanol, propylparaben, disodium EDTA, titanium dioxide.

Questions or Comments?

1-866-992-6722
Monday – Friday 9 AM – 5 PM PST

Dist. By BORBA, Inc., Woodland Hills, CA 91367.

PRINCIPAL DISPLAY PANEL - 15 mL Carton

NEW!

BORBA

AGE DEFYING

SKIN LIGHTENING
SPOT TREATMENT

age spots
+
freckles
+
discoloration

AÇAÍ BERRY
high ORAC antioxidant
Hydroquinone Skin Lightening Cream

CLINICALLY TESTED
INSIDE-OUT SOLUTIONS

0.5 fl. oz. (15 mL)

PRINCIPAL DISPLAY PANEL - 15 mL Carton

BORBA AGE DEFYING   SKIN LIGHTENING SPOT TREATMENT
hydroquinone lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:59734-276
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROQUINONE (HYDROQUINONE) HYDROQUINONE 20 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER  
CETEARYL ETHYLHEXANOATE  
BUTYLENE GLYCOL  
GLYCERIN  
GLYCERYL MONOSTEARATE  
CETYL ALCOHOL  
SQUALANE  
STEARIC ACID  
CETYL PHOSPHATE  
CYCLOMETHICONE 5  
MYRCIARIA DUBIA FRUIT  
ACAI  
FLAX SEED  
ARGAN OIL  
HYALURONATE SODIUM  
PANTHENOL  
ALLANTOIN  
SHEA BUTTER  
DIMETHICONE 350  
.ALPHA.-TOCOPHEROL ACETATE, D-  
SODIUM ASCORBYL PHOSPHATE  
ASCORBIC ACID  
CALCIUM PANTOTHENATE  
MAGNESIUM GLUCONATE  
NIACINAMIDE  
PYRIDOXINE HYDROCHLORIDE  
VITAMIN A PALMITATE  
CYANOCOBALAMIN  
ZINC PICOLINATE  
GLYCYRRHIZINATE DIPOTASSIUM  
LEVOMENOL  
BIOTIN  
ASCORBYL PALMITATE  
ALPHA LIPOIC ACID  
LACTIC ACID  
ANHYDROUS CITRIC ACID  
MALIC ACID  
GREEN TEA LEAF  
DEANOL BITARTRATE  
MANNITOL  
POLYSORBATE 20  
ALUMINUM HYDROXIDE  
SALICYLIC ACID  
AMINOMETHYLPROPANOL  
SODIUM SULFITE  
SODIUM BISULFITE  
METHYLPARABEN  
CHLORPHENESIN  
PHENOXYETHANOL  
PROPYLPARABEN  
EDETATE DISODIUM  
TITANIUM DIOXIDE  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59734-276-28 1 TUBE ( TUBE) in 1 CARTON contains a TUBE
1 15 mL in 1 TUBE This package is contained within the CARTON (59734-276-28)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part358A 01/07/2011

Labeler - Borba, Inc. (605945042)

Revised: 04/2011 Borba, Inc.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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