Label: PORCELANA 24 HOUR SKIN LIGHTENING- hydroquinone, octinoxate cream

  • Category: HUMAN OTC DRUG LABEL

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.

Drug Label Information

Updated April 9, 2019

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  • 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:

    Label

  • INGREDIENTS AND APPEARANCE
    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)
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