AMBI ® Fade Cream - Normal Skin

Manufacturer: Valeant Pharmaceuticals North America LLC | Accupac, Inc.
Effective date: 2014-02-03
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: legacy-cache
Hydrated at: 2026-08-02 01:37:22

Label at a glance#

ProductAMBI Fade Normal Skin

Active ingredientHydroquinone, Octinoxate

Label structure9 sections

Indications and 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.

Dosage and administration

• 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 ...

Storage and handling

Store at room temperature.

Contacts and useful links#

PhoneLabel contact1-800-321-4576

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Hydroquinone (2%)

Octinoxate (2%)

Purpose

OTC - PURPOSE SECTION

Skin Bleaching Agent

Sunscreen

Uses

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

For external use only.

When using this product

OTC - WHEN USING SECTION

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

OTC - DO NOT USE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

Store at room temperature.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

1-800-321-4576

Package/Label Principal Display Panel

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)

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0187-5479-02	2021-05-12	C162847	48780-1	9855e2a2-381f-60a7-e053-dbdaa90a05bd	AMBI ® Fade Cream - Normal Skin
0187-5479-30	2021-05-12	C162847	48780-1	9855e2a2-381f-60a7-e053-dbdaa90a05bd	AMBI ® Fade Cream - Normal Skin
0187-5479-99	2021-05-12	C162847	48780-1	9855e2a2-381f-60a7-e053-dbdaa90a05bd	AMBI ® Fade Cream - Normal Skin
0187-5479-02	2019-11-27	C162847	48780-1	9855e2a2-381f-60a7-e053-dbdaa90a05bd	AMBI ® Fade Cream - Normal Skin
0187-5479-30	2019-11-27	C162847	48780-1	9855e2a2-381f-60a7-e053-dbdaa90a05bd	AMBI ® Fade Cream - Normal Skin
0187-5479-99	2019-11-27	C162847	48780-1	9855e2a2-381f-60a7-e053-dbdaa90a05bd	AMBI ® Fade Cream - Normal Skin

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Hydroquinone	ACTIVE INGREDIENT	XV74C1N1AE	1
Octinoxate	ACTIVE INGREDIENT	4Y5P7MUD51	1
Hydroquinone	ACTIVE MOIETY	XV74C1N1AE	1
Octinoxate	ACTIVE MOIETY	4Y5P7MUD51	1
.Alpha.-Tocopherol Acetate	INACTIVE INGREDIENT	9E8X80D2L0	1
Betaine	INACTIVE INGREDIENT	3SCV180C9W	1
Butylene Glycol	INACTIVE INGREDIENT	3XUS85K0RA	1
Cetyl Alcohol	INACTIVE INGREDIENT	936JST6JCN	1
Cyclomethicone 5	INACTIVE INGREDIENT	0THT5PCI0R	1
Edetate Disodium	INACTIVE INGREDIENT	7FLD91C86K	1
Ethylparaben	INACTIVE INGREDIENT	14255EXE39	1
Glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	1
Glyceryl Monostearate	INACTIVE INGREDIENT	230OU9XXE4	1
Hydroxyethyl Urea	INACTIVE INGREDIENT	MBQ7DDQ7AR	1
Isopropyl Myristate	INACTIVE INGREDIENT	0RE8K4LNJS	1
Lactic Acid	INACTIVE INGREDIENT	33X04XA5AT	1
Methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	1
PEG-100 Stearate	INACTIVE INGREDIENT	YD01N1999R	1
Pentaerythritol Tetrakis(3-(3,5-Di-Tert-Butyl-4-Hydroxyphenyl)Propionate)	INACTIVE INGREDIENT	255PIF62MS	1
Potassium Cetyl Phosphate	INACTIVE INGREDIENT	03KCY6P7UT	1
Propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	1
Sodium Ascorbyl Phosphate	INACTIVE INGREDIENT	836SJG51DR	1
Sodium Metabisulfite	INACTIVE INGREDIENT	4VON5FNS3C	1
Soybean	INACTIVE INGREDIENT	L7HT8F1ZOD	1
Stearic Acid	INACTIVE INGREDIENT	4ELV7Z65AP	1
Water	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 26 matching rows.

AMBI Fade Normal Skin
Hydroquinone and Octinoxate
Hydroquinone
Octinoxate
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

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0187-5479	0187-5479-02, 0187-5479-99, 0187-5479-30

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Hydroquinone	XV74C1N1AE	ACTIB
Octinoxate	4Y5P7MUD51	ACTIB
Water	059QF0KO0R	IACT
Glycerin	PDC6A3C0OX	IACT
Isopropyl Myristate	0RE8K4LNJS	IACT
Stearic Acid	4ELV7Z65AP	IACT
Cyclomethicone 5	0THT5PCI0R	IACT
Cetyl Alcohol	936JST6JCN	IACT
Betaine	3SCV180C9W	IACT
Hydroxyethyl Urea	MBQ7DDQ7AR	IACT
Glyceryl Monostearate	230OU9XXE4	IACT
PEG-100 Stearate	YD01N1999R	IACT
Potassium Cetyl Phosphate	03KCY6P7UT	IACT
Sodium Metabisulfite	4VON5FNS3C	IACT
Pentaerythritol Tetrakis(3-(3,5-Di-Tert-Butyl-4-Hydroxyphenyl)Propionate)	255PIF62MS	IACT
.Alpha.-Tocopherol Acetate	9E8X80D2L0	IACT
Methylparaben	A2I8C7HI9T	IACT
Edetate Disodium	7FLD91C86K	IACT
Lactic Acid	33X04XA5AT	IACT
Propylparaben	Z8IX2SC1OH	IACT
Ethylparaben	14255EXE39	IACT
Sodium Ascorbyl Phosphate	836SJG51DR	IACT
Butylene Glycol	3XUS85K0RA	IACT
Soybean	L7HT8F1ZOD	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 8 · 462 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
Methylparaben	METHYLPARABEN	A2I8C7HI9T	SOLUTION/ DROPS / OPHTHALMIC	0.05 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION / SOFT TISSUE	0.15 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / INTRAMUSCULAR	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
Stearic Acid	STEARIC ACID	4ELV7Z65AP	EMULSION / ORAL	NA		Exact identifier — unii candidate 26 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / ORAL	100 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
Isopropyl Myristate	ISOPROPYL MYRISTATE	0RE8K4LNJS	AEROSOL / TOPICAL	9.3 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
Lactic Acid	LACTIC ACID	33X04XA5AT	INJECTION, SOLUTION / INTRAVENOUS		87 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
Stearic Acid	STEARIC ACID	4ELV7Z65AP	TABLET, EXTENDED RELEASE / ORAL		200 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	SYSTEM / TOPICAL		42 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Stearic Acid	STEARIC ACID	4ELV7Z65AP	TABLET, ORALLY DISINTEGRATING / ORAL		10 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
Sodium Metabisulfite	SODIUM METABISULFITE	4VON5FNS3C	SOLUTION / ORAL		640 mg	Exact identifier — unii candidate 43 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION / PERIDURAL	1 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
Sodium Metabisulfite	SODIUM METABISULFITE	4VON5FNS3C	INJECTION, EMULSION / INTRAVENOUS	0.03 %w/v		Exact identifier — unii candidate 43 equally ranked IID candidates
Butylene Glycol	BUTYLENE GLYCOL	3XUS85K0RA	SYSTEM / TRANSDERMAL	8.12 mg		Exact identifier — unii candidate 2 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	CREAM, AUGMENTED / TOPICAL		2 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Cetyl Alcohol	CETYL ALCOHOL	936JST6JCN	SOLUTION / TOPICAL	NA		Exact identifier — unii candidate 20 equally ranked IID candidates
Sodium Metabisulfite	SODIUM METABISULFITE	4VON5FNS3C	SUSPENSION, EXTENDED RELEASE / ORAL		100 mg	Exact identifier — unii candidate 43 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	CREAM, AUGMENTED / TOPICAL		2 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	CONCENTRATE / ORAL	2.5 mg/5ml		Exact identifier — unii candidate 68 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	SUSPENSION / SUBCUTANEOUS	0.16 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
Cetyl Alcohol	CETYL ALCOHOL	936JST6JCN	AEROSOL, FOAM / RECTAL		17 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION, SUSPENSION / SUBCUTANEOUS	0.16 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
Cetyl Alcohol	CETYL ALCOHOL	936JST6JCN	SUSPENSION / TOPICAL	2.01 %w/w		Exact identifier — unii candidate 20 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SPRAY / NASAL	22.3 mg/1ml		Exact identifier — unii candidate 75 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	ENEMA / RECTAL	0.02 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
Cetyl Alcohol	CETYL ALCOHOL	936JST6JCN	CAPSULE, DELAYED RELEASE / ORAL		59 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
Stearic Acid	STEARIC ACID	4ELV7Z65AP	AEROSOL, FOAM / TOPICAL	8 %w/w		Exact identifier — unii candidate 26 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	SUSPENSION/ DROPS / OPHTHALMIC	0.05 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
Isopropyl Myristate	ISOPROPYL MYRISTATE	0RE8K4LNJS	AEROSOL, SPRAY / TOPICAL	6.89 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
Glyceryl Monostearate	GLYCERYL MONOSTEARATE	230OU9XXE4	AEROSOL, FOAM / TOPICAL	3.27 %w/w		Exact identifier — unii candidate 21 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	LIQUID / TOPICAL	2.5 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / NASAL	140 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SOLUTION / TOPICAL		1971 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SYSTEM / IONTOPHORESIS	168.1 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	SOLUTION/ DROPS / OPHTHALMIC	0.13 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	TABLET, CHEWABLE / ORAL	0.14 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
Lactic Acid	LACTIC ACID	33X04XA5AT	OINTMENT / TOPICAL	ADJ PH		Exact identifier — unii candidate 18 equally ranked IID candidates
Glyceryl Monostearate	GLYCERYL MONOSTEARATE	230OU9XXE4	GRANULE, FOR SUSPENSION / ORAL		4 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	SOLUTION / AURICULAR (OTIC)	0.1 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SYRUP / ORAL		16734 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION / SUBCUTANEOUS		22 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	POWDER, FOR SUSPENSION / ORAL		8 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	LIQUID / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	LOTION / TOPICAL		140 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / SOFT TISSUE	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
Sodium Metabisulfite	SODIUM METABISULFITE	4VON5FNS3C	INJECTION / PERIDURAL	NA		Exact identifier — unii candidate 43 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	SOLUTION / NASAL	100 mg/100ml		Exact identifier — unii candidate 77 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	SOLUTION / OPHTHALMIC		4 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Isopropyl Myristate	ISOPROPYL MYRISTATE	0RE8K4LNJS	GEL, METERED / TRANSDERMAL		50 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	PASTE, DENTIFRICE / DENTAL	0.05 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	TABLET, EXTENDED RELEASE / ORAL		7 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Sodium Metabisulfite	SODIUM METABISULFITE	4VON5FNS3C	TABLET / ORAL	8 mg		Exact identifier — unii candidate 43 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	GEL / TOPICAL		24 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Sodium Metabisulfite	SODIUM METABISULFITE	4VON5FNS3C	INJECTION / INTRACARDIAC	0.09 %w/v		Exact identifier — unii candidate 43 equally ranked IID candidates
Glyceryl Monostearate	GLYCERYL MONOSTEARATE	230OU9XXE4	SUPPOSITORY / RECTAL	35 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
Stearic Acid	STEARIC ACID	4ELV7Z65AP	TABLET, FILM COATED / ORAL		176 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
Isopropyl Myristate	ISOPROPYL MYRISTATE	0RE8K4LNJS	SPRAY / TOPICAL		3665 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
Stearic Acid	STEARIC ACID	4ELV7Z65AP	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		120 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
Isopropyl Myristate	ISOPROPYL MYRISTATE	0RE8K4LNJS	FILM / TRANSDERMAL	58.08 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
Sodium Metabisulfite	SODIUM METABISULFITE	4VON5FNS3C	SOLUTION / RESPIRATORY (INHALATION)	0.3 %w/w		Exact identifier — unii candidate 43 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
69fe609b-b774-4928-82df-c4019c9cd548			2e335de0-1593-4abe-94f0-26b492c83fb6	2014-02-03	Warnings	Exact identifier spl set id: 2e335de0-1593-4abe-94f0-26b492c83fb6

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.