AMBI SKINCARE OILY SKIN FADE- hydroquinone and octinoxate cream

AMBI Skincare Oily Skin Fade by

Drug Labeling and Warnings

AMBI Skincare Oily Skin Fade by is a Otc medication manufactured, distributed, or labeled by L'Oreal USA Products Inc, 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, Cetyl Alcohol, Potassium Cetyl Phosphate, Betaine, Glyceryl Stearate, PEG-100 Stearate, 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?

1-800-946-6354

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

AMBI SKINCARE OILY SKIN FADE 
hydroquinone and octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-002
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)
Cetyl Alcohol (UNII: 936JST6JCN)
Potassium Cetyl Phosphate (UNII: 03KCY6P7UT)
Betaine (UNII: 3SCV180C9W)
Glyceryl Monostearate (UNII: 230OU9XXE4)
PEG-100 Stearate (UNII: YD01N1999R)
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: 49967-002-01	1 in 1 CARTON	10/02/2017	08/24/2020
1		56 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part358A	10/02/2017	08/24/2020

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
Accupac, Inc.		071609663	MANUFACTURE(49967-002)