4 IN 1 PRESSED MINERAL SPF 15 PORCELAIN- titanium dioxide powder

4 in 1 Pressed Mineral SPF 15 Porcelain by

Drug Labeling and Warnings

4 in 1 Pressed Mineral SPF 15 Porcelain by is a Otc medication manufactured, distributed, or labeled by PUR MINERALS. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient : Titanium Dioxide 9 %

PURPOSE

Purpose : Sunscreen

STOP USE

Discontinue use If rash or irritation develops and increases. If irritation persists, consult a health care practitioner or Contact a Poison Control Center right away.

KEEP OUT OF REACH OF CHILDREN

Keep Out of Reach of Children .

INACTIVE INGREDIENT

Inactive Ingredients : Mica , Boron Nitride , Caprylic/Capric Triglyceride , Bismuth Oxychloride , Zinc Stearate , Magnesium Silicate , Magnesium Carbonate ,Sodium Starch Octenylsuccinate, Mannitol,

Sodium Gluconate , Citric Acid, Sodium Citrate , Walthena Indica Leaf Extract , Dextrin , Ferulic Acid, L-Lactic Acid, Butyrospermum Parkii (Shea Butter) , Silica, Thioctic Acid,Sodium Hyarluronate, Retinol,

L-Ascorbic Acid, Ceramide 6 II , Magnolia Officinalis Bark Extract, Vitis Vinifera (Grape) Seed Extract , Tocopherol , Lecithin , Maltodextrin , Vitis Vinifera (Grape) Fruit Skin, Glycerin, Palmitoyl Tripeptide-5,

L-Glucothione, Aloe Barbadensis Leaf Extract, Hydrated Silica , Tocopheryl Acetate , Aqua, Glucosamine HCI, Pisum Sativum (Pea) Extract, Bambus Vulgaris Leaf/Stem Extract, Magnesium Carbonate ,

Iron oxide , May contain : Titanium Dioxide, Ultramarines.

WARNINGS

For external use only. Please avoid contact inside eyes. Rinse with water to remove.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

4 IN 1 PRESSED MINERAL SPF 15 PORCELAIN 
titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67345-0780
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.72 g  in 8 g

Inactive Ingredients
Ingredient Name	Strength
Mica (UNII: V8A1AW0880)
Boron Nitride (UNII: 2U4T60A6YD)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
Bismuth Oxychloride (UNII: 4ZR792I587)
Zinc Stearate (UNII: H92E6QA4FV)
Magnesium Silicate (UNII: 9B9691B2N9)
MAGNESIUM CARBONATE (UNII: 0E53J927NA)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
Shea Butter (UNII: K49155WL9Y)
Acetate Ion (UNII: 569DQM74SC)
Iron (UNII: E1UOL152H7)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67345-0780-0	8 g in 1 CASE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	09/15/2011

Labeler - PUR MINERALS (780516402)