BOTANICAL PURE PACT SPF25 PA PLUS PLUS

Dosage form: powder
Ingredients: TITANIUM DIOXIDE 0.62g in 10g, OCTINOXATE 0.4g in 10g, ZINC OXIDE 0.2g in 10g
Labeler: NATURE REPUBLIC CO., LTD.
NDC Code: 51346-015

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.

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:51346-015
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE0.62 g  in 10 g
OCTINOXATE (OCTINOXATE) OCTINOXATE0.4 g  in 10 g
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE0.2 g  in 10 g
Inactive Ingredients
Ingredient NameStrength
MAGNESIUM MYRISTATE 
DIMETHICONE 
ALUMINUM DIMYRISTATE 
TALC 
ALUMINUM STARCH OCTENYLSUCCINATE 
Packaging
#Item CodePackage Description
1NDC:51346-015-0110 g in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35202/01/2012
Labeler - NATURE REPUBLIC CO., LTD. (631172020)
Registrant - NATURE REPUBLIC CO., LTD. (631172020)
Establishment
NameAddressID/FEIOperations
NATURE REPUBLIC CO., LTD.631172020manufacture(51346-015)

Revised: 08/2012
 
NATURE REPUBLIC CO., LTD.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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