BERRY BABY LIP BALM VIOLET BERRY SPF12- octinoxate, titanium dioxide cream

BERRY BABY LIP BALM VIOLET BERRY by

Drug Labeling and Warnings

BERRY BABY LIP BALM VIOLET BERRY 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 5%, Titanium Dioxide 0.1%

INACTIVE INGREDIENT

Inactive Ingredients:
Petrolatum, Polybutene, Diisostearyl Malate, Silica Dimethyl Silylate, Isoamyl p-Methoxycinnamate, VP/Hexadecene Copolymer, Fragrance,
Butylparaben, Tocopheryl Acetate, Polyethylene, Polyglyceryl-2 Triisostearate, Red 33 Lake, Water, Butylene Glycol, Vaccinium Macrocarpon (Cranberry) Fruit Extract, Fragaria Chiloensis (Strawberry) Fruit Extract, Rubus Idaeus (Raspberry) Fruit Extract, Vaccinium Angustifolium (Blueberry) Fruit Extract, Rubus Fruticosus (Blackberry) Fruit Extract, Methylparaben, Butyrospermum Parkii (Shea) Butter

PURPOSE

Purpose: Moisturizes lips with shine and protects from UV rays.

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: Smoothly apply on lips for extra shine.

DOSAGE AND ADMINISTRATION

How to Use: Smoothly apply on lips for extra shine.

PACKAGE LABEL. PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BERRY BABY LIP BALM VIOLET BERRY  SPF12
octinoxate, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51346-006
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.6 g  in 12 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.012 g  in 12 g

Inactive Ingredients
Ingredient Name	Strength
PETROLATUM (UNII: 4T6H12BN9U)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
WATER (UNII: 059QF0KO0R)
CRANBERRY (UNII: 0MVO31Q3QS)
RASPBERRY (UNII: 4N14V5R27W)
BLACKBERRY (UNII: 8A6OMU3I8L)
SHEA BUTTER (UNII: K49155WL9Y)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51346-006-01	12 g 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(51346-006)