PORCELANA 24 HOUR SKIN LIGHTENING- hydroquinone, octinoxate cream 
CCA Industries Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Porcelana 24 Hour Skin Lightening Cream

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

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?

Package Labeling:

Label

PORCELANA 24 HOUR SKIN LIGHTENING 
hydroquinone, octinoxate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61543-0000
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE) HYDROQUINONE20 mg  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE25 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61543-0000-01 in 1 BOX09/01/2018
185 g in 1 JAR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart358A09/01/2018
Labeler - CCA Industries Inc. (106771041)

Revised: 4/2019
Document Id: 8619d40e-d90f-088e-e053-2a91aa0ae30a
Set id: 446d189f-c954-4902-a88f-89475437ff68
Version: 1
Effective Time: 20190409
 
CCA Industries Inc.