BOTANICAL MOIST PACT by NATURE REPUBLIC CO., LTD.

BOTANICAL MOIST PACT by

Drug Labeling and Warnings

BOTANICAL MOIST 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 MOIST PACT SPF30 PA PLUS PLUS PLUS 23- 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 5%, ZINC OXIDE 2.9%

INACTIVE INGREDIENT

Inactive Ingredients:
Talc, Triethoxycaprylylsilane, Methyl Methacrylate Crosspolymer, Silica, Caprylic/Capric Triglyceride, Methicone, Nylon-12, Dimethicone, HDI/Trimethylol Hexyllactone Crosspolymer, Barium Sulfate, Magnesium Myristate, Ethylene/Acrylic Acid Copolymer, Diisostearyl Malate, Trimethylolpropane Triethylhexanoate, Iron Oxides, Mica, Magnesium Myristate, Ethylhexylglycerin, Glyceryl Caprylate, Fragrance, Ultramarines, Water, Sodium Hyaluronate, Oenothera Biennis (Evening Primrose) Oil, Imperata Cylindrica Root Extract, Glycerin, PEG-8, Carbomer, Methylparaben, Potassium Sorbate, Butylparaben, Ethylparaben, Propylparaben, Isobutylparaben

PURPOSE

Purpose: This moist pact keeps the skin moisturized for a long time as it gently adheres to the skin.

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

DOSAGE AND ADMINISTRATION

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

PACKAGE LABEL. PRINCIPAL DISPLAY PANEL

BOTANICAL MOIST PACT  SPF30 PA PLUS PLUS PLUS 23
titanium dioxide, octinoxate, zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51346-047
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.56 g  in 9 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.45 g  in 9 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	0.26 g  in 9 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: 51346-047-01	9 g in 1 CARTON; Type 0: Not a Combination Product	01/02/2012	11/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	01/02/2012	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(51346-047)

Revised: 2/2020

Document Id: 086ed14a-1335-48b5-a4ec-347d86af32b7

34390-5

Set id: 88f47584-1085-42a0-9ad0-9f750210f66d

Version: 2

Effective Time: 20200226

 

NATURE REPUBLIC CO., LTD.