Porcelana Day Skin Lightening
FDA Label NDC 51545-110

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Ultimark Products Llc for the product Porcelana Day Skin Lightening (NDC 51545-110). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses:, warnings, do not use on, keep out of the reach of children., questions or comments?, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

Principal Display Panelporcelana®for Balanced Skin Tonedayskin Lightening Creamfades Dark Spots Evens Skin Toneprotects Withanti-oxidants & Sunscreen Net Wt 3 Oz/85 G (Porcelana Day Skin Lightening Cream 01)

Principal Display Panelporcelana®for Balanced Skin Tonedayskin Lightening Creamfades Dark Spots Evens Skin Toneprotects Withanti-oxidants & Sunscreen Net Wt 3 Oz/85 G (Porcelana Day Skin Lightening Cream 01)

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