QUEENS ROSE PERFECTION COVER CUSHION PACT- titanium dioxide, octinoxate, zinc oxide, octisalate powder
Cdpharmtec 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 ingredients: Titanium Dioxide 9.59%, ETHYLHEXYL METHOXYCINNAMATE 7.00%, Zinc Oxide 4.90%, ETHYLHEXYL SALICYLATE 4.5%

INACTIVE INGREDIENT

Inactive ingredients: Rosa Damascena Flower Water, Cyclopentasiloxane, Butylene Glycol, Cyclohexasiloxane, Cetyl Ethylhexanoate, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Water, Mica (CI 77019), Glycerin, Niacinamide, Pentylene Glycol, Phenyl Trimethicone, Silica, Phenoxyethanol, Iron Oxides (CI 77492), Magnesium Sulfate, PEG-10 Dimethicone, Trimethylsiloxysilicate, Aluminum Hydroxide, Stearic Acid, Triethoxycaprylylsilane, Dimethicone/Vinyl Dimethicone Crosspolymer, Disteardimonium Hectorite, Iron Oxides (CI 77491), Fragrance(Parfum), Dimethicone, Ethylhexylglycerin, 1,2-Hexanediol, Iron Oxides (CI 77499), Adenosine, Disodium EDTA, Tocopherol, Copper Tripeptide-1, Acetyl Hexapeptide-8

PURPOSE

Purpose: Sunscreen

WARNINGS

Warnings: For external use only When using this product do not get into eyes, Stop use and ask a doctor if rash occurs. Do not use on - deep puncture wounds - animal bites - serious burns.

Keep out of reach of children

DESCRIPTION

Indications & Usage: Apply a thin, even layer using puff.

Dosage & Administration: Take a proper amount of product, and spread it evenly over the entire face..

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

QUEENS ROSE PERFECTION COVER CUSHION PACT
titanium dioxide, octinoxate, zinc oxide, octisalate powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71252-120
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	Titanium Dioxide	1.15 g in 12 g
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	Octinoxate	0.84 g in 12 g
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	0.58 g in 12 g
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	Octisalate	0.54 g in 12 g

Ingredient Name	Strength
Inactive Ingredients
ROSA DAMASCENA FLOWER OIL (UNII: 18920M3T13)
Butylene Glycol (UNII: 3XUS85K0RA)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:71252-120-02	2 in 1 CARTON	03/02/2017
1	NDC:71252-120-01	12 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	03/02/2017

Labeler - Cdpharmtec Co.,ltd (694209262)

Registrant - Cdpharmtec Co.,ltd (694209262)

Name	Address	ID/FEI	Business Operations
Establishment
Cdpharmtec Co.,ltd		694209262	relabel(71252-120)

Name	Address	ID/FEI	Business Operations
Establishment
Cosmax, Inc		689049693	manufacture(71252-120)