TONYMOLY BCDATION MULTI USE SUN- octinoxate, homosalate, octisalate oil

TONYMOLY BCDATION MULTI USE SUN by

Drug Labeling and Warnings

TONYMOLY BCDATION MULTI USE SUN by is a Otc medication manufactured, distributed, or labeled by TONYMOLY CO.,LTD, COSON Co., Ltd._Osan Plant. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients: Ethylhexyl Methoxycinnamate 7.0%, Homosalate 6.0%, Ethylhexyl Salicylate 4.5%

INACTIVE INGREDIENT

Inactive Ingredients: Caprylic/Capric Triglyceride, Octyldodecyl Myristate, Dimethicone, Phenyl Trimethicone, Diethylamino Hydroxybenzoyl Hexyl Benzoate, Methyl Trimethicone, Glyceryl Caprylate, Fragrance, Caprylyl Glycol, Rosa Centifolia Flower Oil, Calendula Officinalis Flower Oil, Cocos Nucifera (Coconut) Oil, Rubus Idaeus (Raspberry) Seed Oil, Polyglyceryl-2 Triisostearate, Water, Methylpropanediol, Propanediol, Polyglyceryl-4 Caprate, Polyglyceryl-2 Dipolyhydroxystearate

PURPOSE

Purpose: Sunscreen

WARNINGS

Warnings: For external use only. Avoid contact with eyes. Keep out of reach of children. Discontinue use if signs of irritation and/or rash appear. Do not use on - deep puncture wounds - animal bites - serious burns

DESCRIPTION

Use: Helps prevent sunburn - if used as directed with other sun protection measures.

Directions: Use at the last step of basic skin care every morning. Take an adequate amount with the pipette, apply on skin, and gently pat to promote absorption into skin.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TONYMOLY BCDATION MULTI USE SUN 
octinoxate, homosalate, octisalate oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59078-323
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	Octinoxate	2.1 g  in 30 mL
Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	Homosalate	1.8 g  in 30 mL
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	Octisalate	1.35 g  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
Octyldodecyl Myristate (UNII: S013N99GR8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59078-323-02	1 in 1 CARTON	01/03/2017
1	NDC: 59078-323-01	30 mL in 1 BOTTLE, DROPPER; 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	01/03/2017

Labeler - TONYMOLY CO.,LTD (688216798)

Registrant - TONYMOLY CO.,LTD (688216798)

Establishment
Name	Address	ID/FEI	Business Operations
TONYMOLY CO.,LTD		688216798	repack(59078-323)

Establishment
Name	Address	ID/FEI	Business Operations
COSON Co., Ltd._Osan Plant		689847210	manufacture(59078-323)