MISSHA GLAM SILKY BODY BALM SPF 27- titanium dioxide, octinoxate, zinc oxide cream

MISSHA GLAM SILKY BODY BALM by

Drug Labeling and Warnings

MISSHA GLAM SILKY BODY BALM by is a Otc medication manufactured, distributed, or labeled by ABLE C&C CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENTS: Titanium Dioxide 7.54%, Ethylhexyl Methoxycinnamate 6.00%, Zinc Oxide 1.92%

INACTIVE INGREDIENT

INACTIVE INGREDIENTS:
Cetyl Ethylhexanoate, Octyldodecyl Myristate, Mica, Polyethylene, Zea Mays (Corn) Starch, Microcrystalline Wax, 4-Methylbenzylidene Camphor, Punica Granatum Seed Oil, Camellia Sinensis Seed Oil, Vitis Vinifera (Grape) Seed Oil, Prunus Armeniaca (Apricot) Kernel Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Talc, Methicone, Hydrogen Dimethicone, BHT, Tin Oxide, Carmine, Caprylyl Glycol, Ethylhexylglycerin, Fragrance

PURPOSE

PURPOSE: This combination of Cosmetic / OTC Drug can be used as a sun protection cream

WARNINGS

WARNING:
For external use only.
Do not swallow.
Keep out of reach of children.
Avoid contact with eyes.
Do not use on exposed wounds or if you are allergic to any ingredients of this product.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

INDICATIONS AND USAGE

INDICATION AND USAGE: Apply as desired with encased puff.

DOSAGE AND ADMINISTRATION

DOSAGE AND ADMINISTRATION: Use appropriate amount according to your skin condition and apply as you desire.

PACKAGE LABEL. PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MISSHA GLAM SILKY BODY BALM  SPF 27
titanium dioxide, octinoxate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13733-016
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.88 g  in 25 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.5 g  in 25 g
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.48 g  in 25 g

Inactive Ingredients
Ingredient Name	Strength
Cetyl Ethylhexanoate (UNII: 134647WMX4)
Octyldodecyl Myristate (UNII: S013N99GR8)
Mica (UNII: V8A1AW0880)
Talc (UNII: 7SEV7J4R1U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13733-016-01	25 g in 1 CARTON

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	03/01/2012

Labeler - ABLE C&C CO., LTD. (689540284)

Registrant - ABLE C&C CO., LTD. (689540284)

Establishment
Name	Address	ID/FEI	Business Operations
ABLE C&C CO., LTD.		689540284	manufacture(13733-016)