QUEENS ROSE WHOLE IN ONE SUNBLOCK- octinoxate, octisalate, ensulizole, avobenzone cream

QUEENS ROSE WHOLE IN ONE SUNBLOCK by

Drug Labeling and Warnings

QUEENS ROSE WHOLE IN ONE SUNBLOCK by is a Otc medication manufactured, distributed, or labeled by Cdpharmtec Co.,ltd, Cosmecca Korea Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients: Ethylhexyl Methoxycinnamate 5.50%, Ethylhexyl Salicylate 5.00%, Phenylbenzimidazole Sulfonic Acid 4.00%, Butyl Methoxydibenzoylmethane 3.00%

INACTIVE INGREDIENT

Inactive ingredients: Water, Butylene Glycol,Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, C12-15 Alkyl Benzoate,Arbutin,Cetearyl Alcohol,Glycerin,Glyceryl Stearate,Cetearyl Olivate,Polysorbate 60, Sorbitan Olivate,PEG-100 Stearate,Sorbitan Stearate,Sodium Hydroxide,Dimethicone, Methyl Methacrylate Crosspolymer, VP/Hexadecene Copolymer, Polyacrylate-13, Caprylyl Glycol, Ethylhexylglycerin, Fragrance, Polyisobutene, Ceramide NP, Human Stem Cell Conditioned Media, Disodium EDTA, 1,2-Hexanediol, Tocopheryl Acetate, Phospholipids, Adenosine, Polysorbate 20, BHT, Phytosphingosine, Sorbitan Isostearate, CI 17200

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: Helps prevent and relieve chapped or cracked skin.

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

QUEENS ROSE WHOLE IN ONE SUNBLOCK 
octinoxate, octisalate, ensulizole, avobenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71252-100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.75 g  in 50 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	2.5 g  in 50 g
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42)	ENSULIZOLE	2.0 g  in 50 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1.5 g  in 50 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Butylene Glycol (UNII: 3XUS85K0RA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71252-100-02	1 in 1 CARTON	03/02/2017
1	NDC: 71252-100-01	50 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

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

Labeler - Cdpharmtec Co.,ltd (694209262)

Registrant - Cdpharmtec Co.,ltd (694209262)

Establishment
Name	Address	ID/FEI	Business Operations
Cdpharmtec Co.,ltd		694209262	relabel(71252-100)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmecca Korea Co., Ltd.		688830827	manufacture(71252-100)