Label: PLAGENTRA SOOTHING REVOLUTION BB- titanium dioxide, octinoxate, zinc oxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 68988-110-01 - Packager: C.A Pharm Co., Ltd.
- 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 December 5, 2014
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- ACTIVE INGREDIENT
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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
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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
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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
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PLAGENTRA SOOTHING REVOLUTION BB
titanium dioxide, octinoxate, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68988-110 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide 2.77 g in 30 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.25 g in 30 g Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 0.35 g in 30 g Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Butylene Glycol (UNII: 3XUS85K0RA) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68988-110-01 30 g in 1 CARTON Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 04/01/2014 Labeler - C.A Pharm Co., Ltd. (688198385) Registrant - C.A Pharm Co., Ltd. (688198385) Establishment Name Address ID/FEI Business Operations C.A Pharm Co., Ltd. 688198385 manufacture(68988-110)