SUPER BB ALL-IN-1- titanium dioxide, zinc oxide cream
Mei Shual Cosmetics 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 Ingredients:

Titanium Dioxide 15%

Zinc Oxide 10%

Purpose

Keep out of reach of children.

Warnings

Dosage & Administration

Indications & Usage

Titanium Dioxide, Zinc Oxide, Mica, Boron Nitride, Water, Zinc Stearate, Octyldodecyl Stearoyl Stearate, Lauroyl Lysine, Dimethicone, Glycerin, Triethylhexanoin, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Potassium Sorbate, Sodium Dehydroacetate, Tocopheryl Acetate, Lecithin, Tetrahexyldecyl Ascorbate, Salix Alba(Willow) Bark Extract Powder

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SUPER BB ALL-IN-1
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69184-001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	15 mg in 100 mg
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	10 in 100 mg

Ingredient Name	Strength
Inactive Ingredients
MICA (UNII: V8A1AW0880)
BORON NITRIDE (UNII: 2U4T60A6YD)
WATER (UNII: 059QF0KO0R)
ZINC STEARATE (UNII: H92E6QA4FV)
OCTYLDODECYL STEAROYL STEARATE (UNII: 3D47Q6D93C)
LAUROYL LYSINE (UNII: 113171Q70B)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
SALIX ALBA BARK (UNII: 205MXS71H7)
BROWN IRON OXIDE (UNII: 1N032N7MFO)
D&C RED NO. 6 (UNII: 481744AI4O)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
ULTRAMARINE BLUE (UNII: I39WR998BI)
FERRIC FERROCYANIDE (UNII: TLE294X33A)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69184-001-01	100 mg in 1 PACKAGE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	09/17/2014

Labeler - Mei Shual Cosmetics Co., Ltd. (656375912)

Name	Address	ID/FEI	Business Operations
Establishment
Mei Shual Cosmetics Co., Ltd.		656375912	manufacture(69184-001)