AMBI ® Fade Cream - Oily Skin

Manufacturer: Valeant Pharmaceuticals North America LLC | Accupac, Inc.
Effective date: 2015-01-21
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: legacy-cache
Hydrated at: 2026-08-02 01:33:58

Label at a glance#

ProductAMBI Fade Oily 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, 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?

OTC - QUESTIONS SECTION

1-800-321-4576

Package/Label Principal Display Panel - Ambi Fade Cream Oily Skin Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AMBI®
SKINCARE

Fade Cream

Fades dark spots
for even, natural
skin tone

With Vitamin E and
Alpha Hydroxy Acid

OILY SKIN

NET WT. 2 OZ. (56 g)

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0187-5480-02	2021-05-20	C162847	48780-1	9d75b9cf-d6af-f424-e053-dadaa90a57ce	AMBI ® Fade Cream - Oily Skin
0187-5480-02	2020-01-31	C162847	48780-1	9d75b9cf-d6af-f424-e053-dadaa90a57ce	AMBI ® Fade Cream - Oily 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
Edetate Disodium	INACTIVE INGREDIENT	7FLD91C86K	1
Ethylparaben	INACTIVE INGREDIENT	14255EXE39	1
Glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	1
Glyceryl Monostearate	INACTIVE INGREDIENT	230OU9XXE4	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 · 24 matching rows.

AMBI Fade Oily Skin
Hydroquinone and Octinoxate
Hydroquinone
Octinoxate
Water
Glycerin
Isopropyl Myristate
Stearic Acid
Cetyl Alcohol
Potassium Cetyl Phosphate
Betaine
Glyceryl Monostearate
PEG-100 Stearate
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
0187-5480	0187-5480-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 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
Cetyl Alcohol	936JST6JCN	IACT
Potassium Cetyl Phosphate	03KCY6P7UT	IACT
Betaine	3SCV180C9W	IACT
Glyceryl Monostearate	230OU9XXE4	IACT
PEG-100 Stearate	YD01N1999R	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 · 459 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
Lactic Acid	LACTIC ACID	33X04XA5AT	INJECTION / INTRAMUSCULAR	1.16 %w/v		Exact identifier — unii candidate 18 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	3.6 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
Glycerin	GLYCERIN	PDC6A3C0OX	CAPSULE, COATED / ORAL	14.21 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	DROPS / NASAL	26 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	DROPS / OPHTHALMIC	0.05 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	AEROSOL, FOAM / TOPICAL		21 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	GEL / TOPICAL		500 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	GEL / VAGINAL		5 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SUSPENSION / OPHTHALMIC		58 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Sodium Metabisulfite	SODIUM METABISULFITE	4VON5FNS3C	INJECTION, SOLUTION / INTRAVENOUS		79 mg	Exact identifier — unii candidate 43 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	TABLET, EXTENDED RELEASE / ORAL		10 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Isopropyl Myristate	ISOPROPYL MYRISTATE	0RE8K4LNJS	GEL / TRANSDERMAL		85 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	INJECTION / INTRAVENOUS		33750 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SOAP / TOPICAL	0.76 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
Soybean	SOYBEAN	L7HT8F1ZOD	CAPSULE / ORAL	NA		Exact identifier — unii candidate 2 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	ELIXIR / ORAL	800 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	DROPS / AURICULAR (OTIC)	0.01 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
Stearic Acid	STEARIC ACID	4ELV7Z65AP	POWDER, FOR SUSPENSION / ORAL	1203 mg/5ml		Exact identifier — unii candidate 26 equally ranked IID candidates
Stearic Acid	STEARIC ACID	4ELV7Z65AP	PELLET / SUBCUTANEOUS	0.97 mg		Exact identifier — unii candidate 26 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	TABLET, COATED / ORAL	0.21 mg		Exact identifier — unii candidate 77 equally ranked IID candidates
Isopropyl Myristate	ISOPROPYL MYRISTATE	0RE8K4LNJS	LOTION / TOPICAL		50 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
Sodium Metabisulfite	SODIUM METABISULFITE	4VON5FNS3C	TABLET, CHEWABLE / ORAL	0.2 mg		Exact identifier — unii candidate 43 equally ranked IID candidates
Sodium Metabisulfite	SODIUM METABISULFITE	4VON5FNS3C	INJECTION, SOLUTION / INTRAMUSCULAR		96 mg	Exact identifier — unii candidate 43 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	SOLUTION / ORAL		432 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, SUSPENSION / INTRAMUSCULAR	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
Cetyl Alcohol	CETYL ALCOHOL	936JST6JCN	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	59 mg		Exact identifier — unii candidate 20 equally ranked IID candidates
Glyceryl Monostearate	GLYCERYL MONOSTEARATE	230OU9XXE4	CREAM / VAGINAL		140 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	INJECTION, EMULSION / INTRAVENOUS		59 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
Sodium Metabisulfite	SODIUM METABISULFITE	4VON5FNS3C	INJECTION, SOLUTION, CONCENTRATE / INTRAVENOUS	0.15 %w/v		Exact identifier — unii candidate 43 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	SOLUTION/ DROPS / OPHTHALMIC	0.05 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	SOLUTION / TOPICAL		216 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	DROPS / ORAL	300 mg/1ml		Exact identifier — unii candidate 75 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	INJECTION, SUSPENSION / SOFT TISSUE		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	LIQUID / ORAL		2 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	OINTMENT / OPHTHALMIC	0.05 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	JELLY / TOPICAL	NA		Exact identifier — unii candidate 75 equally ranked IID candidates
Cetyl Alcohol	CETYL ALCOHOL	936JST6JCN	SOLUTION / TOPICAL	NA		Exact identifier — unii candidate 20 equally ranked IID candidates
Stearic Acid	STEARIC ACID	4ELV7Z65AP	EMULSION / ORAL	NA		Exact identifier — unii candidate 26 equally ranked IID candidates
Sodium Metabisulfite	SODIUM METABISULFITE	4VON5FNS3C	INJECTION / INTRA-ARTICULAR	0.2 %w/v		Exact identifier — unii candidate 43 equally ranked IID candidates
Glyceryl Monostearate	GLYCERYL MONOSTEARATE	230OU9XXE4	LIQUID / TOPICAL	1 %w/w		Exact identifier — unii candidate 21 equally ranked IID candidates
Glyceryl Monostearate	GLYCERYL MONOSTEARATE	230OU9XXE4	EMULSION / ORAL	NA		Exact identifier — unii candidate 21 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	ELIXIR / ORAL		5621 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	SHAMPOO / TOPICAL	0.15 %w/w		Exact identifier — unii candidate 79 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
Stearic Acid	STEARIC ACID	4ELV7Z65AP	OINTMENT / TOPICAL	15 %w/w		Exact identifier — unii candidate 26 equally ranked IID candidates
Cetyl Alcohol	CETYL ALCOHOL	936JST6JCN	TABLET, ORALLY DISINTEGRATING / ORAL		9 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	CONCENTRATE / ORAL		12 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	SYRUP / ORAL		40 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Lactic Acid	LACTIC ACID	33X04XA5AT	CAPSULE / ORAL		132 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	DROPS / OPHTHALMIC	0.01 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	ENEMA / RECTAL	0.02 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
Lactic Acid	LACTIC ACID	33X04XA5AT	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	LIQUID / NASAL	2 mg/1ml		Exact identifier — unii candidate 77 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	SOLUTION / INTRAVENOUS	0.13 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	SYSTEM / TOPICAL		42 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SOLUTION / RESPIRATORY (INHALATION)	5 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
Cetyl Alcohol	CETYL ALCOHOL	936JST6JCN	TABLET / ORAL	NA		Exact identifier — unii candidate 20 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SUSPENSION, EXTENDED RELEASE / ORAL		4 mg	Exact identifier — unii candidate 68 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
67ac8d8b-34ce-48ae-a43c-b0148416a903			e9a9e024-ad30-4199-97a4-36d97070cb2c	2015-01-21	Warnings	Exact identifier spl set id: e9a9e024-ad30-4199-97a4-36d97070cb2c

Reported adverse events (FAERS/openFDA)#

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