TOURMANIUM BB SPF30 PA PLUS PLUS- zinc oxide cream 
NUGA MEDICAL 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 INGREDIENT: Zinc Oxide 2.88%

INACTIVE INGREDIENT

INACTIVE INGREDIENTS:
Water, Butylene Glycol, Titanium Dioxide, Cetyl Ethylhexanoate, Talc, Octyldodecyl Myristate, Hydrogenated Polydecene, Jojoba Esters, Arbutin, Lecithin, Glyceryl Stearate, Sorbitan Sesquioleate, Glycerin, Cetearyl Alcohol, Cetyl Alcohol, Sorbitan Olivate, Dimethicone, Polysorbate 60, Aluminum Hydroxide, Stearic Acid, Polyacrylate-13, Propylene Glycol Stearate, Polyisobutene, Sorbitan Laurate, Dimethicone/Methicone Copolymer, Polysorbate 20, Glyceryl Polyacrylate, Propylene Glycol Laurate, Propylene Glycol, Acacia Seyal Gum Extract, Laminaria Japonica Extract, Saccharomyces Ferment Filtrate, Tourmaline, Gelatin, Bentonite, Sodium Citrate, Adenosine,Sorbitan Isostearate, Triethoxycaprylylsilane, Citric Acid, Xanthan gum, Tocopheryl Acetate, Disodium EDTA, Phenoxyethanol,Caprylyl Glycol, Ethylhexylglycerin, 1,2-Hexanediol

PURPOSE

PURPOSE: UVA/UVB protection

WARNINGS

WARNINGS:
For external use only
Do Not Use - On wounds or damaged skin
When using this product:
- do not use other than directed
Stop use - If allergic reaction or irritation occurs

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

INDICATIONS AND USAGE

HOW TO USE
After your daily skin care regimen, apply an even layer onto the face in upward and outward motions

DOSAGE AND ADMINISTRATION

HOW TO USE
After your daily skin care regimen, apply an even layer onto the face in upward and outward motions

PACKAGE LABEL. PRINCIPAL DISPLAY PANEL

Image of carton

TOURMANIUM BB  SPF30 PA PLUS PLUS
zinc oxide cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:43275-140
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 1.15 g  in 40 mL
Inactive Ingredients
Ingredient Name Strength
Water (UNII: 059QF0KO0R)  
Butylene Glycol (UNII: 3XUS85K0RA)  
Cetyl Ethylhexanoate (UNII: 134647WMX4)  
Talc (UNII: 7SEV7J4R1U)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:43275-140-01 40 mL in 1 CARTON
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part352 03/01/2012
Labeler - NUGA MEDICAL CO., LTD. (690034673)
Registrant - NUGA MEDICAL CO., LTD. (690034673)
Establishment
Name Address ID/FEI Business Operations
NUGA MEDICAL CO., LTD. 690034673 manufacture(43275-140)

Revised: 10/2012
Document Id: d2ddaca8-2e93-4299-b0a4-afa7447fe334
Set id: 2e5d79d1-d1b8-44b5-81cf-c48427525b91
Version: 1
Effective Time: 20121009
 
NUGA MEDICAL CO., LTD.