AMBI FADE NORMAL SKIN- hydroquinone and octinoxate cream

AMBI Fade by

Drug Labeling and Warnings

AMBI Fade by is a Otc medication manufactured, distributed, or labeled by Valeant Pharmaceuticals North America LLC, Accupac, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Hydroquinone (2%)

Octinoxate (2%)

Purpose

Skin Bleaching Agent

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 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 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/Comments?

1-800-321-4576

Package/Label Principal Display Panel

AMBI®

SKINCARE

Fade Cream

Fades dark spots for even, natural skin tone

With Vitamin E and Alpha Hydroxy Acid

NORMAL SKIN

NET WT. 2 OZ. (56g)

INGREDIENTS AND APPEARANCE

AMBI FADE  NORMAL SKIN
hydroquinone and octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0187-5479
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Hydroquinone (UNII: XV74C1N1AE) (Hydroquinone - UNII:XV74C1N1AE)	Hydroquinone	20 mg  in 1 g
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	20 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Glycerin (UNII: PDC6A3C0OX)
Isopropyl Myristate (UNII: 0RE8K4LNJS)
Stearic Acid (UNII: 4ELV7Z65AP)
Cyclomethicone 5 (UNII: 0THT5PCI0R)
Cetyl Alcohol (UNII: 936JST6JCN)
Betaine (UNII: 3SCV180C9W)
Hydroxyethyl Urea (UNII: MBQ7DDQ7AR)
Glyceryl Monostearate (UNII: 230OU9XXE4)
PEG-100 Stearate (UNII: YD01N1999R)
Potassium Cetyl Phosphate (UNII: 03KCY6P7UT)
Sodium Metabisulfite (UNII: 4VON5FNS3C)
Pentaerythritol Tetrakis(3-(3,5-Di-Tert-Butyl-4-Hydroxyphenyl)Propionate) (UNII: 255PIF62MS)
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)
Methylparaben (UNII: A2I8C7HI9T)
Edetate Disodium (UNII: 7FLD91C86K)
Lactic Acid (UNII: 33X04XA5AT)
Propylparaben (UNII: Z8IX2SC1OH)
Ethylparaben (UNII: 14255EXE39)
Sodium Ascorbyl Phosphate (UNII: 836SJG51DR)
Butylene Glycol (UNII: 3XUS85K0RA)
Soybean (UNII: L7HT8F1ZOD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0187-5479-02	1 in 1 CARTON
1		56 g in 1 TUBE
2	NDC: 0187-5479-99	1 in 1 CARTON
2		56 g in 1 TUBE
3	NDC: 0187-5479-30	24 in 1 CARTON
3		3 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part358A	02/04/2014

Labeler - Valeant Pharmaceuticals North America LLC (042230623)

Establishment
Name	Address	ID/FEI	Business Operations
Accupac, Inc.		071609663	MANUFACTURE(0187-5479)