PORCELANA DAY SKIN LIGHTENING- hydroquinone and octinoxate cream

Porcelana Day Skin Lightening by

Drug Labeling and Warnings

Porcelana Day Skin Lightening by is a Otc medication manufactured, distributed, or labeled by Ultimark Products LLC, Humco Holding Group, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Active Ingredient

Hydroquinone U.S.P. 2%

Purpose

Skin Lightener

Active Ingredient

Octinoxate 2.5%

Purpose

Sunscreen

Uses:

• Lightens dark spots, blemishes, freckles and discolorations of the skin caused by sun exposure, age, acne, pregnancy and the use of oral contraceptives.
  
• Contains a sunscreen to keep darkening from reoccurring.

Warnings

For External use only. Avoid contact with eyes. Some users of this product may experience a mild skin irritation. If skin irritation becomes severe, stop use and consult a doctor.

Do Not use on

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

Keep out of the reach of children.

If swallowed, get medical help or contact a Poison Control Center right away. If pregnant or breast-feeding, ask a doctor before use.

Questions or Comments?

Call 1-800-820-8717

Monday - Friday 9:00 - 6:00 EST or visit us at: www.nicenebrands.com

¿Las Preguntas o Comentarios? Llame al 1-800-820-8717

Lunes - Viernes 9:00 - 6:00 EST, o visítenos en:

www.nicenebrands.com

Directions

• Adults: Apply a small amount as a thin layer on the affected area twice daily, or use 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 when used on very dark skin.
  
• Children under 12 years of age: do not use unless directed by a doctor 
  
• 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 in order to prevent darkening from reoccurring.

Inactive Ingredients

Water, Mineral Oil, Glyceryl Stearate, Cetyl Alcohol, Isopropyl Palmitate, PEG-100 Stearate, Propylene Glycol, Emulsifying Wax NF, Stearic Acid, Hydroxyethylcellulose, Tocopheryl Acetate, Magnesium Ascorbyl Phosphate, Beta-Carotene, Disodium EDTA, C13-14 Isoparaffin, Sodium Meta-Bisulfite, Citric Acid, BHT, Methylparaben, Propylparaben, Diazolidinyl Urea, Fragrance.  

PRINCIPAL DISPLAY PANEL

PORCELANA®
FOR BALANCED SKIN TONE
DAY
SKIN LIGHTENING CREAM
FADES DARK SPOTS       EVENS SKIN TONE
Protects With
Anti-Oxidants & Sunscreen       Net Wt 3 oz/85 g

INGREDIENTS AND APPEARANCE

PORCELANA DAY SKIN LIGHTENING 
hydroquinone and octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51545-110
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE)	HYDROQUINONE	0.02 g  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.025 g  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)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)
.BETA.-CAROTENE (UNII: 01YAE03M7J)
EDETATE DISODIUM (UNII: 7FLD91C86K)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51545-110-03	1 in 1 BOX	12/14/2017
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	04/01/2011

Labeler - Ultimark Products LLC (964734078)

Registrant - Humco Holding Group, Inc. (825672884)