Ambi Fade Normal Skin

Dosage form: cream
Ingredients: Hydroquinone 20mg in 1g, Octinoxate 20mg in 1g
Labeler: Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc.
NDC Code: 58232-0509

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.

Ambi® Fade Cream - Normal Skin

Drug Facts

Active IngredientsPurpose
Hydroquinone (2)%)Skin Bleaching Agent
Octinoxate (2%)Sunscreen

Uses
  • For the gradual fading of dark (brownish)skin discolorations such as freckles, age and liver spots or pigment that may occur in pregnancy or from the use of oral contraceptives.
  • Contains a sunscreen to help prevent darkening from reoccurring.

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

This product is not for use in the prevention of sunburn.

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

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, or protective clothing to cover bleached skin after treatment is completed to prevent darkening from reoccurring.

Other information

Store at room temperature.

Inactive Ingredients

Water, Glycerin, Isopropyl Myristate, Stearic Acid, Cyclopentasiloxane, Cetyl Alcohol, Betaine, Hydroxyethyl Urea, Glyceryl Stearate, PEG-100 Stearate, Potassium Cetyl Phosphate, Dimethicone Crosspolymer, Sodium Metabisulfite, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Fragrance, Tocopheryl Acetate, Methylparaben, Disodium EDTA, Lactic Acid, Propylparaben, Ethylparaben, PEG-16 Soy Sterol, Sodium Ascorbyl Phosphate, Butylene Glycol, Glycine Soja (Soybean) Protein

Questions?

888-TRY-AMBI; Outside US, dial collect 215-273-8755

Distributed in the US by:
JOHNSON & JOHNSON CONSUMER PRODUCTS COMPANY
Division of Johnson & Johnson Consumer Companies, Inc.
Skillman, NJ 08558-9418

PRINCIPAL DISPLAY PANEL - 56g Tube Carton

Ambi®
SKINCARE

Fade Cream
NORMAL SKIN

NET WT. 2 OZ. (56g)

AMBI FADE   NORMAL SKIN
hydroquinone and octinoxate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58232-0509
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Hydroquinone (Hydroquinone) Hydroquinone20 mg  in 1 g
Octinoxate (Octinoxate) Octinoxate20 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Water 
Glycerin 
Isopropyl Myristate 
Stearic Acid 
Cyclomethicone 5 
Cetyl Alcohol 
Betaine 
Hydroxyethyl Urea 
Glyceryl Monostearate 
PEG-100 Stearate 
Potassium Cetyl Phosphate 
Sodium Metabisulfite 
Pentaerythritol Tetrakis(3-(3,5-Di-Tert-Butyl-4-Hydroxyphenyl)Propionate) 
.Alpha.-Tocopherol Acetate 
Methylparaben 
Edetate Disodium 
Lactic Acid 
Propylparaben 
Ethylparaben 
Sodium Ascorbyl Phosphate 
Butylene Glycol 
Soybean 
Packaging
#Item CodePackage Description
1NDC:58232-0509-11 TUBE in 1 CARTON
156 g in 1 TUBE
2NDC:58232-0509-224 TUBE in 1 CARTON
23 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart358A05/30/201207/01/2013
Labeler - Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. (830803164)

Revised: 03/2013
 
Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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