MANGO BEBE LIP CARE SPF15 RED MANGO- octinoxate, octisalate, titanium dioxide stick
NATURE REPUBLIC 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.

----------

ACTIVE INGREDIENT

Active Ingredients: ETHYLHEXYL METHOXYCINNAMATE 6%, ETHYLHEXYL SALICYLATE 3%, TITANIUM DIOXIDE 0.3%

INACTIVE INGREDIENT

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

PURPOSE

Purpose: Hydrates lips with a variety of Mango scents.

WARNINGS

Cautions:
For external use only.
Avoid contact with eyes and mouth.
Discontinue use if signs of irritation or rash appear.
Keep out of reach of children.
Replace the cap after use.

KEEP OUT OF REACH OF CHILDREN

INDICATIONS AND USAGE

How to Use: Smoothly apply on lips for conditioned and moistful lips.

DOSAGE AND ADMINISTRATION

How to Use: Smoothly apply on lips for conditioned and moistful lips.

PACKAGE LABEL. PRINCIPAL DISPLAY PANEL

Image of carton

MANGO BEBE LIP CARE SPF15 RED MANGO
octinoxate, octisalate, titanium dioxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:51346-026
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.21 g in 3.5 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.105 g in 3.5 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.01 g in 3.5 g

Ingredient Name	Strength
Inactive Ingredients
PETROLATUM (UNII: 4T6H12BN9U)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
CERESIN (UNII: Q1LS2UJO3A)
MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:51346-026-01	3.5 g in 1 CARTON; Type 0: Not a Combination Product	03/01/2012	12/30/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	03/01/2012	12/30/2018

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

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

Name	Address	ID/FEI	Business Operations
Establishment
Kolmar Korea Co.,LTD. Gwanjeong Factory		689512611	manufacture(51346-026)

Revised: 7/2021

Document Id: 2d8f6c4a-ecb6-4fa0-b7f9-fc56f3b5993d

Set id: 0f97bc5c-c48c-4fb9-80f6-6e970dd7479d

Version: 2

Effective Time: 20210709

NATURE REPUBLIC CO., LTD.