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

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 : Titanium Dioxide 9 %

Purpose : Sunscreen

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 .

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.

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

Image of Label

4 IN 1 PRESSED MINERAL SPF 15 PORCELAIN
titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:67345-6082
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.387 g in 4.3 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:67345-6082-0	4.3 g in 1 CARTRIDGE

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

Labeler - PUR MINERALS (780516402)