FDA.reportPublic FDA data

Porcelana Skin Lightening Cream Nighttime Hydration

Manufacturer
CCA Industries Inc.
Effective date
2019-04-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:20:44

Label at a glance#

ProductPorcelana Skin Lightening Nighttime Hydration
Active ingredientHYDROQUINONE
Label structure8 sections

Indications and uses

For the gradual fading of dark spots in the skin such as age liver spots and pigment in the skin that may occur in pregnancy or from the use of oral contraceptives. 

Dosage and administration

Adults apply a small amount as a thin layer on the affected area(s) as part of your nighttime routine or as directed by a doctor. For best results, use with Porcelana Night. If no improvement is seen after three months of treatment, use of this product should be discontinued. 

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Hydroquinone U.S.P. 2%

Purpose

OTC - PURPOSE SECTION

Skin Lightener

Uses:

INDICATIONS & USAGE SECTION

For the gradual fading of dark spots in the skin such as age liver spots and pigment in the skin that may occur in pregnancy or from the use of oral contraceptives. 

Warnings

WARNINGS SECTION

For External use only. Avoid contact with eyes. 

Do not use 

OTC - DO NOT USE SECTION

on children under 12 years of age unless directed by a doctor.

When using this product

OTC - WHEN USING SECTION

some users may experience a mild skin irritation.

Stop use and ask a doctor

OTC - STOP USE SECTION

if skin irritation becomes severe.

Keep out of the reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

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 to prevent darkening from reoccurring.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults apply a small amount as a thin layer on the affected area(s) as part of your nighttime routine or as directed by a doctor. For best results, use with Porcelana Night. If no improvement is seen after three months of treatment, use of this product should be discontinued. 

Other Information

SPL UNCLASSIFIED SECTION

  • Lightening effect of this product may not be noticeable when used on very dark skin.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Mineral Oil, Glyceryl Stearate, Cetyl Alcohol, Isopropyl Palmitate, PEG-100 Stearate, Propylene Glycol, Emulsifying Wax NF, Stearic Acid, Hydroxyethylcellulose, Disodium EDTA, Sodium Metabisulfite, Fragrance, Diazolidinyl Urea, Persea Gratissima (Avocado) Oil, Methylparaben, Propylparaben, BHT, Magnesium Ascorbyl Phosphate, Tocopheryl (Vitamin E) Acetate, Retinyl (Vitamin A) Palmitate, Citric Acid

Questions or Comments?

OTC - QUESTIONS SECTION

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label3Label3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61543-0002-02022-07-21C16284748780-1ba0f9c33-4030-a910-e053-dadaa90a0b85Porcelana Skin Lightening Cream Nighttime Hydration
61543-0002-02021-01-29C16284748780-1ba0f9c33-4030-a910-e053-dadaa90a0b85Porcelana Skin Lightening Cream Nighttime Hydration

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61543-000261543-0002-0

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
MINERAL OILT5L8T28FGPIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
CETYL ALCOHOL936JST6JCNIACT
ISOPROPYL PALMITATE8CRQ2TH63MIACT
PEG-100 STEARATEYD01N1999RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
STEARIC ACID4ELV7Z65APIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
SODIUM METABISULFITE4VON5FNS3CIACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
AVOCADO OIL6VNO72PFC1IACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
MAGNESIUM ASCORBYL PHOSPHATE0R822556M5IACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
HYDROQUINONEXV74C1N1AEACTIB

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
e45422d8-9f95-519e-e053-2995a90adfb1178f6ee0-363c-46b9-8b9b-d635c4f382412022-07-21WarningsExact identifier
spl set id: 178f6ee0-363c-46b9-8b9b-d635c4f38241

Reported adverse events (FAERS/openFDA)#

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