Label: AMBI FADE NORMAL SKIN- hydroquinone and octinoxate cream
- NDC Code(s): 0187-5479-02, 0187-5479-30, 0187-5479-99
- Packager: Valeant Pharmaceuticals North America LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Updated February 3, 2014
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- Active Ingredients
Skin Bleaching Agent
- 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.
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.
- 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.Close
- 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) ProteinClose
- Package/Label Principal Display Panel
Fades dark spots for even, natural skin tone
With Vitamin E and Alpha Hydroxy Acid
NET WT. 2 OZ. (56g)Close
- 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)