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

PLAGENTRA SOOTHING REVOLUTION BB by

Drug Labeling and Warnings

PLAGENTRA SOOTHING REVOLUTION BB by is a Otc medication manufactured, distributed, or labeled by C.A Pharm Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

PLAGENTRA SOOTHING REVOLUTION BB 
titanium dioxide, octinoxate, zinc oxide cream

Product 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)