MANGO BEBE LIP ESSENCE SPF15- octinoxate, octisalate solution

MANGO BEBE LIP ESSENCE by

Drug Labeling and Warnings

MANGO BEBE LIP ESSENCE 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%, ETHYLHEXYL SALICYLATE 3%

INACTIVE INGREDIENT

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

PURPOSE

Purpose: Moisturizes and softens rough, chapped lips before applying lip color cosmetics.

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

KEEP OUT OF REACH OF CHILDREN

INDICATIONS AND USAGE

How to Use: Gently apply on lips to nourish for conditioned lips.

DOSAGE AND ADMINISTRATION

How to Use: Gently apply on lips to nourish for conditioned lips.

PACKAGE LABEL. PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MANGO BEBE LIP ESSENCE  SPF15
octinoxate, octisalate solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51346-028
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.60 g  in 10 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.30 g  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
MINERAL OIL (UNII: T5L8T28FGP)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
MANGO (UNII: I629I3NR86)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51346-028-01	10 mL in 1 CARTON

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

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(51346-028)