BOTANICAL PURE PACT by NATURE REPUBLIC CO., LTD.

BOTANICAL PURE PACT by

Drug Labeling and Warnings

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

Drug Details [pdf]

BOTANICAL PURE PACT SPF25 PA PLUS PLUS- 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 4%, ZINC OXIDE 2%

INACTIVE INGREDIENT

Inactive Ingredients:
Magnesium Myristate, Dimethicone, Hydrogenated Lecithin, Mica, Aluminum Dimyristate, Talc, Methicone, Aluminum Starch Octenylsuccinate, Silica, Nylon-12, Trimethylolpropane Triethylhexanoate, Triethylhexanoin, Dipentaerythrityl Hexahydroxystearate/Hexastearate/Hexarosinate, Iron Oxides, Ethylhexylglycerin, Glyceryl Caprylate, Fragrance, Calcium Carbonate, Lavandula Angustifolia (Lavender) Water, Benzyl Alcohol, Dehydroacetic Acid, Water

PURPOSE

Purpose: This pure pact makes the skin tone bright and clear by controlling excessive sebum production.

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 the puff, gently apply an appropriate amount to the entire face or oily areas.

DOSAGE AND ADMINISTRATION

How to Use: Using the puff, gently apply an appropriate amount to the entire face or oily areas.

PACKAGE LABEL. PRINCIPAL DISPLAY PANEL

BOTANICAL PURE PACT  SPF25 PA PLUS PLUS
titanium dioxide, octinoxate, zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51346-015
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.62 g  in 10 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.4 g  in 10 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	0.2 g  in 10 g

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51346-015-01	10 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(51346-015)

Revised: 2/2020

Document Id: 91d44349-b0a5-448c-a051-c870ba9fc9f5

34390-5

Set id: 8cd5dad8-1230-40ac-b7db-8e1bf6a476dd

Version: 2

Effective Time: 20200226