TONYMOLY BCDATION MULTI USE SUN- octinoxate, homosalate, octisalate oil
TONYMOLY CO.,LTD

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.

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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

Image of carton

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	01/03/2017

Labeler - TONYMOLY CO.,LTD (688216798)

Registrant - TONYMOLY CO.,LTD (688216798)

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

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