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

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	1.15 g in 40 mL

Ingredient Name	Strength
Inactive Ingredients
Water (UNII: 059QF0KO0R)
Butylene Glycol (UNII: 3XUS85K0RA)
Cetyl Ethylhexanoate (UNII: 134647WMX4)
Talc (UNII: 7SEV7J4R1U)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:43275-140-01	40 mL in 1 CARTON; Type 0: Not a Combination Product	03/01/2012	12/31/2013

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	03/01/2012	12/31/2013

Labeler - Nuga Medical Co.,Ltd. (690034673)

Registrant - Nuga Medical Co.,Ltd. (690034673)

Name	Address	ID/FEI	Business Operations
Establishment
Nuga Medical Co.,Ltd.		690034673	manufacture(43275-140)

Revised: 8/2017

Document Id: 8bf70e0f-2e8c-4ce3-917c-e7b2b9f65bf3

Set id: 2e5d79d1-d1b8-44b5-81cf-c48427525b91

Version: 2

Effective Time: 20170801

Nuga Medical Co.,Ltd.