ESMIA AIR CUSHION CARAMEL 31- titanium dioxide, octinoxate, zinc oxide powder

ESMIA AIR CUSHION Caramel 31 by

Drug Labeling and Warnings

ESMIA AIR CUSHION Caramel 31 by is a Otc medication manufactured, distributed, or labeled by Bs Cosmetics Co.,ltd., EYESOME. Co.,Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients 

Active ingredients: Titanium Dioxide 7.60%, Ethylhexyl Methoxycinnamate 7.00%, Zinc Oxide 0.98%

INACTIVE INGREDIENT

Inactive ingredients:

Water,Cyclopentasiloxane,Glycerin,Cyclohexasiloxane,Phenyl Trimethicone,Butylene Glycol Dicaprylate/Dicaprate
Butylene Glycol,Trimethylsiloxysilicate,Pentylene Glycol,PEG-10 Dimethicone,Niacinamide,Methylene Bis-Benzotriazolyl Tetramethylbutylphenol,aprylyl Methicone
Cetyl PEG/PPG-10/1 Dimethicone,Magnesium Sulfate,Biosaccharide Gum-1,Polyhydroxystearic Acid,Decyl Glucoside,Phenoxyethanol
Disteardimonium Hectorite,Acrylates/Stearyl Acrylate/Dimethicone Methacrylate Copolymer,Triethoxycaprylylsilane,Aluminum Hydroxide
Lecithin,Isostearic Acid,Isopropyl Myristate,Ethylhexyl Palmitate,Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer,Tocopheryl Acetate
Silica Dimethyl Silylate,Methyl Methacrylate Crosspolymer,Ethylhexylglycerin,Dimethicone/Vinyl Dimethicone Crosspolymer,Allantoin
HDI/Trimethylol Hexyllactone Crosspolymer,Polyglyceryl-3 Polyricinoleate,Adenosine,Mica (CI 77019),Disodium EDTA,Propylene Glycol
Xanthan Gum,Aloe Barbadensis Leaf Juice Powder,Silica,Sophora Japonica Fruit Extract,Centella Asiatica Extract,1,2-Hexanediol
Iron Oxides (CI 77492),Iron Oxides (CI 77491),Iron Oxides (CI 77499),Fragrance

Purpose

Purpose: Sunscreen

Warnings

Warnings:

FOR EXTERNAL USE ONLY

- Do not use on damaged or broken skin

- When using this product, Keep out of eyes. Rinse with water to remove.

- Stop use and ask a doctor if rash occurs.

- Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

DESCRIPTION

Uses:

Helps prevent sunburn

Directions:

Apply liberally and uniformly to all exposed areas 15-20 minutes before sun exposure.

Reapply often (every 2 hours) and after swimming, excessive perspiration and washing to ensure maximum sun protection.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ESMIA AIR CUSHION CARAMEL 31 
titanium dioxide, octinoxate, zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72600-120
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.14 g  in 15 g
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	Octinoxate	1.05 g  in 15 g
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	0.14 g  in 15 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72600-120-02	1 in 1 CARTON	09/01/2018
1	NDC: 72600-120-01	15 g in 1 CONTAINER; 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	09/01/2018

Labeler - Bs Cosmetics Co.,ltd. (694791429)

Registrant - Bs Cosmetics Co.,ltd. (694791429)

Establishment
Name	Address	ID/FEI	Business Operations
EYESOME. Co.,Ltd.		557795360	manufacture(72600-120)