Label: PLAGENTRA SOOTHING REVOLUTION BB- titanium dioxide, octinoxate, zinc oxide cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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 December 5, 2014

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active Ingredients: Titanium Dioxide 9.24%, Ethylhexyl Methoxycinnamate 7.5%, Zinc Oxide 1.17%

  • INACTIVE INGREDIENT

    Inactive Ingredients:
    Water, Cyclopentasiloxane, Butylene Glycol, Ethylhexyl Triazone, Di-C12-13 Alkyl Tartrate, Cetyl Ethylhexanoate, Dicaprylyl Carbonate, Cetyl PEG/PPG-10/1 Dimethicone, Glycerin, PEG-10 Dimethicone, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, 1,2-Hexanediol, Polyglyceryl-4 Isostearate, Hydrated Silica, Sodium Chloride, Magnesium Sulfate, CI 77492, Quaternium-18 Bentonite, Copernicia Cerifera (Carnauba) Wax, Ozokerite, Hydrogen Dimethicone, Aloe Arborescens Leaf Extract, Bisabolol, Beeswax, Aluminum Hydroxide, Dimethicone Crosspolymer, CI 77491, Polyglutamic Acid, Triethoxycaprylylsilane, CI 77499, Caprylic/Capric Triglyceride, Tocopheryl Acetate, Chamomilla Recutita (Matricaria) Flower/Leaf Extract, Eugenia Caryophyllus (Clove) Flower Extract, Citrus Paradisi (Grapefruit) Fruit Extract, Eucalyptus Globulus Leaf Extract, Citrus Junos Fruit Extract, Sophora Angustifolia Root Extract, Centella Asiatica Extract, Scutellaria Baicalensis Root Extract, Polygonum Cuspidatum Root Extract, Camellia Sinensis Leaf Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Anthemis Nobilis Flower Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Polysorbate 80, Allantoin, Dipotassium Glycyrrhizate, Alcohol, Adenosine, Lecithin, Ubiquinone

  • PURPOSE

    Purpose: UVA/UVB Protection

  • WARNINGS

    Warnings:
    1. Stop using the product and go to a doctor immediately if one of the following symptoms occurs. If immediate care is not sought, the symptoms may worsen :
    1) Itching, redness, swelling, rash, etc. 2) If one of the symptoms above occurs due to direct sunlight.
    2. Do not apply the product to wounds or skin with dermatitis such as eczema.
    3. Storage and Handling, 1) Keep the lid closed after use. 2) Keep the product out of children's reach. 3) Keep away from direct sunlight, do not store at high or low temperature.
    4. It contains AHA. If it is your first time to use this product, take a small amount and gently apply to the skin to check if it cause andy trouble to your skin.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of babies and children.

  • INDICATIONS & USAGE

    Indication and usage:
    1) Tighten the lid after using it.
    2) Don't keep it in the place where the temperature is extremely hot or low and exposed to the direct sunlight.
    3) Using your fingertips, dab it onto any target areas, particularly underneath the eyes. Then slowly begin blending in a circular motion.

  • DOSAGE & ADMINISTRATION

    Dosage and administration:
    Get an appropriate amount of BB cream apply them onto your face and use gentle patting motions to spread and blend it into your skin.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    PLAGENTRA SOOTHING REVOLUTION BB 
    titanium dioxide, octinoxate, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68988-110
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide2.77 g  in 30 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.25 g  in 30 g
    Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION0.35 g  in 30 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68988-110-0130 g in 1 CARTON
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35204/01/2014
    Labeler - C.A Pharm Co., Ltd. (688198385)
    Registrant - C.A Pharm Co., Ltd. (688198385)
    Establishment
    NameAddressID/FEIBusiness Operations
    C.A Pharm Co., Ltd.688198385manufacture(68988-110)