FDA Label for Porcelana Day Skin Lightening

View Indications, Usage & Precautions

Porcelana Day Skin Lightening Product Label

The following document was submitted to the FDA by the labeler of this product Ultimark Products Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient



Hydroquinone U.S.P. 2%

Octinoxate 2.5%


Purpose



Skin Lightener

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


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