FDA.reportPublic FDA data

AMBI Skincare Oily Skin Fade

Manufacturer
L'Oreal USA Products Inc | Accupac, Inc.
Effective date
2019-12-31
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 23:46:56

Label at a glance#

ProductAMBI Skincare Oily Skin Fade
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.

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

1-800-946-6354

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49967-00249967-002-01

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
NameUNIIKind
HydroquinoneXV74C1N1AEACTIB
Octinoxate4Y5P7MUD51ACTIB
Water059QF0KO0RIACT
GlycerinPDC6A3C0OXIACT
Isopropyl Myristate0RE8K4LNJSIACT
Stearic Acid4ELV7Z65APIACT
Cetyl Alcohol936JST6JCNIACT
Potassium Cetyl Phosphate03KCY6P7UTIACT
Betaine3SCV180C9WIACT
Glyceryl Monostearate230OU9XXE4IACT
PEG-100 StearateYD01N1999RIACT
Sodium Metabisulfite4VON5FNS3CIACT
Pentaerythritol Tetrakis(3-(3,5-Di-Tert-Butyl-4-Hydroxyphenyl)Propionate)255PIF62MSIACT
.Alpha.-Tocopherol Acetate9E8X80D2L0IACT
MethylparabenA2I8C7HI9TIACT
Edetate Disodium7FLD91C86KIACT
Lactic Acid33X04XA5ATIACT
PropylparabenZ8IX2SC1OHIACT
Ethylparaben14255EXE39IACT
Sodium Ascorbyl Phosphate836SJG51DRIACT
Butylene Glycol3XUS85K0RAIACT
SoybeanL7HT8F1ZODIACT

Source Document#

Source XML

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
abc0b624-2d35-4f09-88e4-9a553fcfb89a28c62a5b-ee6e-45a7-a86b-1945d4bb2d062019-12-31WarningsExact identifier
spl id: abc0b624-2d35-4f09-88e4-9a553fcfb89a
spl set id: 28c62a5b-ee6e-45a7-a86b-1945d4bb2d06

Reported adverse events (FAERS/openFDA)#

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