AMBI SKINCARE NORMAL SKIN FADE- hydroquinone and octinoxate cream 
L'Oreal USA Products 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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Drug Facts

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?

1-800-946-6354

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AMBI SKINCARE NORMAL SKIN FADE 
hydroquinone and octinoxate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-547
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Hydroquinone (UNII: XV74C1N1AE) (Hydroquinone - UNII:XV74C1N1AE) Hydroquinone20 mg  in 1 g
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate20 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49967-547-011 in 1 CARTON08/24/201708/24/2020
156 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart358A08/24/201708/24/2020
Labeler - L'Oreal USA Products Inc (002136794)
Establishment
NameAddressID/FEIBusiness Operations
Accupac, Inc.071609663MANUFACTURE(49967-547)

Revised: 12/2019
 
L'Oreal USA Products Inc