BY FLOWER LIP CARE SPF15 RED- octinoxate, octisalate, titanium dioxide stick

BY FLOWER LIP CARE SPF15 RED by

Drug Labeling and Warnings

BY FLOWER LIP CARE SPF15 RED 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%), TITANIUM DIOXIDE (0.25%)

INACTIVE INGREDIENT

INACTIVE INGREDIENTS: PETROLATUM,POLYGLYCERYL-2 TRIISOSTEARATE,DIISOSTEARYL MALATE,JOJOBA ESTERS,TOCOPHEROL,POLYETHYLENE,MICROCRYSTALLINE WAX,HYDROGENATED POLYISOBUTENE,MEADOWFOAM DELTA-LACTONE,PHYTOSTERYL HYDROXYSTEARATE,EUPHORBIA CERIFERA (CANDELILLA) WAX,HYDROGENATED COCO-GLYCERIDES,CERESIN,PRUNUS AMYGDALUS DULCIS (SWEET ALMOND) OIL,MANGIFERA INDICA (MANGO) SEED BUTTER,TBHQ,CAPRYLYL GLYCOL,GLYCERYL CAPRYLATE,FRAGRANCE,RED 7,TOCOPHERYL ACETATE,CI 15850,BHT,IRON OXIDES(CI77492),IRON OXIDES(CI77499)

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 CARE SPF15 RED 
octinoxate, octisalate, titanium dioxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51346-306
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.21 g  in 3.5 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.10 g  in 3.5 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.008 g  in 3.5 g

Inactive Ingredients
Ingredient Name	Strength
PETROLATUM (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51346-306-01	3.5 g in 1 CONTAINER; 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	02/01/2015

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

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

Establishment
Name	Address	ID/FEI	Business Operations
NATURE REPUBLIC CO., LTD.		631172020	manufacture(51346-306)