FDA.reportPublic FDA data

Porcelana 24 Hour Skin Lightening Cream

Manufacturer
CCA Industries Inc.
Effective date
2019-04-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:59:44

Label at a glance#

ProductPorcelana 24 Hour Skin Lightening
Active ingredientHYDROQUINONE, OCTINOXATE
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 oralcontraceptives. 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(s) as part of your daily routine or as directed by a doctor. 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%

Octyl methoxycinnamate 2.5%

Purpose

OTC - PURPOSE SECTION

Skin Lightener

Sun Screen

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 oralcontraceptives. Contains a sunscreen to help prevent darkening from reoccurring.

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.

This product is not for use in the prevention of sunburn,

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 daily routine or as directed by a doctor. 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, Methylparaben, Propylparaben, BHT, Tocopheryl (Vitamin E) Acetate, Beta-Carotene, Magnesium Ascorbyl Phosphate, Citric Acid.

Questions or Comments?

OTC - QUESTIONS SECTION

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
HYDROQUINONE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
85490a6b-2306-6bf2-c51b-eb63537dc2daProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61543-0000-02021-01-29C16284748780-1ba0f9c33-3bc4-a910-e053-dadaa90a0b85Porcelana 24 Hour Skin Lightening Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61543-0000-0Porcelana 24 Hour Skin Lightening85 g in 1 JARCREAM851
61543-0000-0Porcelana 24 Hour Skin Lightening1 in 1 BOXCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61543-0000PORCELANA 24 HOUR SKIN LIGHTENING (HYDROQUINONE, OCTINOXATE) CREAM [CCA INDUSTRIES INC.]1Legacy NDC, 2 package rows20190620_446d189f-c954-4902-a88f-89475437ff68.zip

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61543-000061543-0000-0

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 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
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
BETA CAROTENE01YAE03M7JIACT
MAGNESIUM ASCORBYL PHOSPHATE0R822556M5IACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
HYDROQUINONEXV74C1N1AEACTIB
OCTINOXATE4Y5P7MUD51ACTIB

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
8619d40e-d90f-088e-e053-2a91aa0ae30a446d189f-c954-4902-a88f-89475437ff682019-04-09WarningsExact identifier
spl id: 8619d40e-d90f-088e-e053-2a91aa0ae30a
spl set id: 446d189f-c954-4902-a88f-89475437ff68

Reported adverse events (FAERS/openFDA)#

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