CELLPIUM SHIELD SUN BB- titanium dioxide, octinoxate, octisalate, zinc oxide cream

Cellpium shield sun bb by

Drug Labeling and Warnings

Cellpium shield sun bb by is a Otc medication manufactured, distributed, or labeled by MEDIPOST Co.,Ltd., Kolmar Korea Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient: TITANIUM DIOXIDE 11.00%, ETHYLHEXYL METHOXYCINNAMATE 6.50%, ETHYLHEXYL SALICYLATE 4.00%, ZINC OXIDE 3.91%

INACTIVE INGREDIENT

Inactive Ingredients: WATER, CYCLOPENTASILOXANE, BUTYLENE GLYCOL, TRIDECYL TRIMELLITATE, GLYCERIN, LAURYL PEG-10 TRIS(TRIMETHYLSILOXY)SILYLETHYL DIMETHICONE, DIMETHICONE, C12-15 ALKYL BENZOATE, NIACINAMIDE, ISOPROPYL ISOSTEARATE, CAPRYLYL METHICONE, IRON OXIDES(CI 77492), DISTEARDIMONIUM HECTORITE, DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE, MAGNESIUM SULFATE, LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, DIMETHICONE CROSSPOLYMER, MICA, TALC, ALUMINUM HYDROXIDE, AMINOPROPYL DIMETHICONE, PHENOXYETHANOL, POLYMETHYLSILSESQUIOXANE, HUMAN CORD BLOOD CELL CONDITIONED MEDIA, IRON OXIDES(CI 77491), TRIBEHENIN, POLYGLYCERYL-6 POLYRICINOLEATE, STEARIC ACID, ALUMINA, ALLANTOIN, ETHYLHEXYLGLYCERIN, TOCOPHERYL ACETATE, FRAGRANCE, OCTYLDODECANOL, IRON OXIDES(CI 77499), SILICA, TRIETHOXYCAPRYLYLSILANE, ADENOSINE, SODIUM HYALURONATE, ECHIUM PLANTAGINEUM SEED OIL, CARDIOSPERMUM HALICACABUM FLOWER/LEAF/VINE EXTRACT, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL UNSAPONIFIABLES, TOCOPHEROL, MORINGA OLEIFERA SEED OIL, NELUMBO NUCIFERA CALLUS CULTURE EXTRACT, HAMAMELIS VIRGINIANA (WITCH HAZEL) EXTRACT, ALCOHOL, PENTYLENE GLYCOL, HONEY EXTRACT, SODIUM HYDROXIDE, XANTHAN GUM

PURPOSE

Purpose: Sunscreen

WARNINGS

Warnings: 1. If the following symptoms occur while using this product, discontinue use immediately and consult your dermatologist: (1). Red spots, swelling, itching, or irritation (2). If the application area develops the aforesaid symptoms after exposure to direct sunlight. 2. Do not apply on areas with injuries, eczema, or dermatitis. 3. Storage & Handling (1). Keep the cap closed after use. (2). Keep out of reach of children. (3). Keep away from direct sunlight and extreme high or low temperatures. 4. The UV protection factor of this product is measured according to the UV protection factor measurement method specified in the 「Regulation on the Review of Functional Cosmetics」. The rating of UVA protection factor is measured according to the method of measuring the UVA protection effect as specified in the「Regulation on the Review of Functional Cosmetics」. 5. Do not use on skin around the eyes. In case of contact with the eyes, wash off immediately with running water.

Directions

Directions: The mild UV protectant protects skin from UV rays and urban pollutants and provides abundant moisture and nourishment to skin

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CELLPIUM SHIELD SUN BB 
titanium dioxide, octinoxate, octisalate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70506-110
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	5.5 g  in 50 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.25 g  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	2.0 g  in 50 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	1.95 g  in 50 mL

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: 70506-110-01	50 mL in 1 CARTON; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	02/01/2016

Labeler - MEDIPOST Co.,Ltd. (688268817)

Registrant - MEDIPOST Co.,Ltd. (688268817)

Establishment
Name	Address	ID/FEI	Business Operations
MEDIPOST Co.,Ltd.		688268817	repack(70506-110)

Establishment
Name	Address	ID/FEI	Business Operations
Kolmar Korea Co., Ltd.		689512611	manufacture(70506-110)