BOTANICAL VANILLA PACT SPF30 PA PLUS PLUS PLUS VANILLA NATURAL- titanium dioxide, octinoxate, zinc oxide powder

BOTANICAL VANILLA PACT by

Drug Labeling and Warnings

BOTANICAL VANILLA PACT 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: TITANIUM DIOXIDE 10.1%, ETHYLHEXYL METHOXYCINNAMATE 5%, ZINC OXIDE 2.9%

INACTIVE INGREDIENT

Inactive Ingredients:
Talc, Dimethicone, Mica, Methicone, Silica, Hexyl Laurate, Hydrogenated Castor Oil Isostearate, HDI/Trimethylol Hexyllactone Crosspolymer, Methylparaben, Fragrance, Propylparaben, Olea Europaea (Olive) Fruit Oil, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Cedrus Atlantica Bark Oil, Citrus Aurantium Dulcis (Orange) Fruit Extract, Citrus Grandis (Grapefruit) Fruit Extract, Lavandula Angustifolia (Lavender) Flower/Leaf/Stem Extract, Citrus Aurantifolia (Lime) Oil, Coriandrum Sativum (Coriander) Fruit Oil, Salvia Officinalis (Sage) Oil,
Artemisia Absinthium Extract, Chamomilla Recutita (Matricaria) Flower Extract, Vanilla Planifolia Fruit Extract, Santalum Album (Sandalwood) Oil, Montmorillonite

PURPOSE

Purpose: This vanilla-scented pact makes the skin moist with a matte finish.

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: Using a puff, apply an appropriate amount onto the face and gently pat to spread evenly.

DOSAGE AND ADMINISTRATION

How to Use: Using a puff, apply an appropriate amount onto the face and gently pat to spread evenly.

PACKAGE LABEL. PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BOTANICAL VANILLA PACT  SPF30 PA PLUS PLUS PLUS VANILLA NATURAL
titanium dioxide, octinoxate, zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51346-013
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.111 g  in 11 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.55 g  in 11 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.319 g  in 11 g

Inactive Ingredients
Ingredient Name	Strength
TALC (UNII: 7SEV7J4R1U)
DIMETHICONE (UNII: 92RU3N3Y1O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
METHYLPARABEN (UNII: A2I8C7HI9T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51346-013-01	11 g in 1 CARTON

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	02/01/2012

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(51346-013)