BOTANICAL VANILLA PACT SPF30 PA PLUS PLUS PLUS VANILLA NATURAL

Dosage form: powder
Ingredients: TITANIUM DIOXIDE 1.111g in 11g, OCTINOXATE 0.55g in 11g, ZINC OXIDE 0.319g in 11g
Labeler: NATURE REPUBLIC CO., LTD.
NDC Code: 51346-013

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 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

BOTANICAL VANILLA PACT  SPF30 PA PLUS PLUS PLUS VANILLA NATURAL
titanium dioxide, octinoxate, zinc oxide powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51346-013
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE1.111 g  in 11 g
OCTINOXATE (OCTINOXATE) OCTINOXATE0.55 g  in 11 g
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE0.319 g  in 11 g
Inactive Ingredients
Ingredient NameStrength
TALC 
DIMETHICONE 
SILICON DIOXIDE 
HEXYL LAURATE 
METHYLPARABEN 
Packaging
#Item CodePackage Description
1NDC:51346-013-0111 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(51346-013)

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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