BY FLOWER LIP ESSENCE SPF15- octinoxate, octisalate cream

BY FLOWER LIP ESSENCE SPF15 by

Drug Labeling and Warnings

BY FLOWER LIP ESSENCE SPF15 by is a Otc medication manufactured, distributed, or labeled by NATURE REPUBLIC CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENTS: ETHYLHEXYL METHOXYCINNAMATE (6.00%), ETHYLHEXYL SALICYLATE (3.00%)

INACTIVE INGREDIENT

INACTIVE INGREDIENTS: MINERAL OIL,BUTYLENE/ETHYLENE/STYRENE COPOLYMER,ETHYLENE/PROPYLENE/STYRENE COPOLYMER,POLYBUTENE,MINERAL OIL,DIISOSTEARYL MALATE,SILICA,CAPRYLYL GLYCOL,GLYCERYL CAPRYLATE,FRAGRANCE,TOCOPHERYL ACETATE,FRAGRANCE,BHT,WATER,BUTYLENE GLYCOL,MANGIFERA INDICA (MANGO) FRUIT EXTRACT

PURPOSE

Purpose: Sunscreen [UV Protection]

CAUTIONS

CAUTIONS: 1. For external use only. 2. Discontinue use if signs of irritation or rashes appear. 3. Keep out of reach of children 4. Replace the cap after use.

HOW TO USE

HOW TO USE: Take an adequate amount and thoroughly apply on the lips for smooth and soft lips.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BY FLOWER LIP ESSENCE SPF15 
octinoxate, octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51346-307
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.6 mg  in 10 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.3 mg  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
MINERAL OIL (UNII: T5L8T28FGP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51346-307-01	10 mL in 1 TUBE; Type 0: Not a Combination Product	02/01/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	02/01/2015

Labeler - NATURE REPUBLIC CO., LTD. (631172020)

Registrant - NATURE REPUBLIC CO., LTD. (631172020)

Establishment
Name	Address	ID/FEI	Business Operations
Kolmar Korea Co.,LTD. Gwanjeong Factory		689512611	manufacture(51346-307)