Fade Cream Hydroquinone Skin Bleaching Agent Oily Skin

Manufacturer
Ambi Enterprises LLC
Effective date
2021-04-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:47:03

Label at a glance#

ProductHydroquinone Skin Bleaching Agent Oily Skin
Active ingredientHYDROQUINONE, OCTINOXATE
Label structure8 sections

Indications and uses

for the gradual fading of dark (brownish) discolorations in the skin such as freckles, age and liver spots, pigment in the skin 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 doctor  sun exposure should be limited by using a sunscreen ...

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) discolorations in the skin such as freckles, age and liver spots, pigment in the skin 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 doctor 
  • sun exposure should be limited by using a sunscreen agent, a sun blocking agent, or protective clothing to cover bleached skin after treatment is completed in order to prevent darkening from reoccurring

Other information

SPL UNCLASSIFIED SECTION

• for expiration date, see bottom of carton
• store at room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, glycerin, isopropyl myristate, stearic acid, cetyl alcohol, potassium cetyl phosphate, betaine, glycerl 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 or comments?

OTC - QUESTIONS SECTION

1-800-946-6354

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73453-00173453-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

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
e8cf65ab-2312-593e-e053-2995a90abbb7bff4d932-c27f-1bec-e053-2995a90a320f2022-09-16WarningsExact identifier
spl set id: bff4d932-c27f-1bec-e053-2995a90a320f

Reported adverse events (FAERS/openFDA)#

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