BOTANICAL VANILLA by NATURE REPUBLIC CO., LTD.

BOTANICAL VANILLA by

Drug Labeling and Warnings

BOTANICAL VANILLA by is a Otc medication manufactured, distributed, or labeled by NATURE REPUBLIC CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

BOTANICAL VANILLA SPF25 PA PLUS 01- titanium dioxide, octinoxate, zinc oxide powder 
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.

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ACTIVE INGREDIENT

Active Ingredients: Titanium Dioxide 6.2%, Ethylhexyl Methoxycinnamate 2%, Zinc Oxide 1.9%

INACTIVE INGREDIENT

Inactive Ingredients:
Talc, Methicone, Aluminum Starch Octenylsuccinate, Dimethicone, Iron Oxides, Mica, Methylparaben, Montmorillonite, Propylparaben, Fragrance, 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

PURPOSE

Purpose: This vanilla-scented powder makes the skin smooth 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: As the last step of make up or touch up, apply an appropriate amount to the face using a puff and gently pat the skin.

DOSAGE AND ADMINISTRATION

How to Use: As the last step of make up or touch up, apply an appropriate amount to the face using a puff and gently pat the skin.

PACKAGE LABEL. PRINCIPAL DISPLAY PANEL

BOTANICAL VANILLA  SPF25 PA PLUS 01
titanium dioxide, octinoxate, zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51346-010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.55 g  in 25 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.5 g  in 25 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	0.475 g  in 25 g

Inactive Ingredients
Ingredient Name	Strength
TALC (UNII: 7SEV7J4R1U)
DIMETHICONE (UNII: 92RU3N3Y1O)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51346-010-01	25 g in 1 CARTON; Type 0: Not a Combination Product	02/01/2012	11/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	02/01/2012	11/01/2019

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

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

Establishment
Name	Address	ID/FEI	Business Operations
Cosmax, Inc.		689049693	manufacture(51346-010)

Revised: 2/2020

Document Id: 9d8b8066-04c8-4bd9-b5ce-c8c454d8d3d6

34390-5

Set id: 2624c8be-5d01-4e57-aab6-e7a13d3c9ca9

Version: 2

Effective Time: 20200226

 

NATURE REPUBLIC CO., LTD.