Ultra Glow Fade Cream (2% Hydroquinone and 1.5% Padimate O)
- Manufacturer
- Keystone Laboratories
- Effective date
- 2018-01-03
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 22:53:57
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
2% Hydroquinone ..... Skin Lightener
1.5% Padimate O.......Subscreen
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
OTC - PURPOSE SECTION
Skin lightener
INDICATIONS & USAGE SECTION
Skin Lightener
Sunscreen
WARNINGS SECTION
Warnings:
For external use only. Children under 12 years of age: Do not use unless directed by a doctor. Some users of this product may experience a mild skin irritation. If skin irritation becomes severe, stop use and consult a doctor. Avoid contact with eyes, rinse with water to remove. Sun exposure should be limited by using a sunscreen agent, a sun blocking agent, or protective clothing to cover bleached skin during and after treatment is completed in order to prevent darkening from reoccurring. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
DOSAGE & ADMINISTRATION SECTION
Directions:
Adults: Apply a small amount in a thin layer on the affected area twice daily or 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 on very dark skin.
OTHER SAFETY INFORMATION
Other Information: Protect the product in this container from excessive heat and direct sun. For expiration date, please see bottom of jar.
Distributed by
KEYSTONE LABORATORIES © 2013
1-800-772-8860 / Memphis, TN 38101-2026
MADE IN U.S.A.
PM-LB 0011
INACTIVE INGREDIENT SECTION
Inactive Ingredients:
water, stearyl stearate, propylene glycol, cetyl alcohol, isopropyl myristate, mineral oil, sodium metabisulfite, fragrance, steareth 20, methylparaben, butylhydoxytoluene, prophyl gallate, sodium sulfite, sodium sulfite, tetrasodium EDTA, propylparaben, citric acid, aloe barbadensis (Leaf Juice)
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| HYDROQUINONE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 85490a6b-2306-6bf2-c51b-eb63537dc2da | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 58318-008-01 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-ebe8-f424-e053-dadaa90a57ce | Ultra Glow Fade Cream (2% Hydroquinone and 1.5% Padimate O) |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 58318-008-01 | Ultra Glow Fade | 102 g in 1 JAR | CREAM | 102 | 1 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Ultra Glow Fade
- Hydroquinone
- WATER
- GLYCERYL MONOSTEARATE
- SODIUM LAURYL SULFATE
- PROPYLENE GLYCOL
- ISOPROPYL MYRISTATE
- CETYL ALCOHOL
- SODIUM DITHIONATE
- STEARYL STEARATE
- STEARETH-20
- METHYLPARABEN
- PROPYLPARABEN
- BUTYLATED HYDROXYTOLUENE
- PROPYL GALLATE
- SODIUM METABISULFITE
- BISULFITE ION
- EDETATE DISODIUM
- CITRIC ACID MONOHYDRATE
- METHYL ALCOHOL
- SODIUM SULFITE
- SULFITE ION
- PADIMATE O
- ALOE VERA LEAF
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 58318-008 | 58318-008-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 61f59bc5-2f47-764a-e053-2991aa0acb19 | 61f59bc5-2f46-764a-e053-2991aa0acb19 | 2018-01-03 | Warnings | 61f59bc5-2f47-764a-e053-2991aa0acb19 61f59bc5-2f46-764a-e053-2991aa0acb19 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
