PORCELANA 24 HOUR SKIN LIGHTENING- hydroquinone, octinoxate cream

Porcelana 24 Hour Skin Lightening by

Drug Labeling and Warnings

Porcelana 24 Hour Skin Lightening by is a Otc medication manufactured, distributed, or labeled by CCA Industries Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Hydroquinone U.S.P. 2%

Octyl methoxycinnamate 2.5%

Purpose

Skin Lightener

Sun Screen

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.

Warnings

For External use only. Avoid contact with eyes. 

Do not use 

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

When using this product

some users may experience a mild skin irritation.

Stop use and ask a doctor

if skin irritation becomes severe.

Keep out of the reach of children.

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

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

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

Inactive Ingredients

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?

• Call toll-free:1-800-595-6230
• Visit us at www.porcelana.com

Package Labeling:

INGREDIENTS AND APPEARANCE

PORCELANA 24 HOUR SKIN LIGHTENING 
hydroquinone, octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61543-0000
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE)	HYDROQUINONE	20 mg  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	25 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
MINERAL OIL (UNII: T5L8T28FGP)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
CETYL ALCOHOL (UNII: 936JST6JCN)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
PEG-100 STEARATE (UNII: YD01N1999R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
STEARIC ACID (UNII: 4ELV7Z65AP)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
BETA CAROTENE (UNII: 01YAE03M7J)
MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61543-0000-0	1 in 1 BOX	09/01/2018
1		85 g in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part358A	09/01/2018

Labeler - CCA Industries Inc. (106771041)