ESMIA AIR CUSHION LIGHT BEIGE 21- titanium dioxide, octinoxate, zinc oxide powder 
Bs 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 

Active ingredients: Titanium Dioxide 9.98%, Ethylhexyl Methoxycinnamate 7.00%, Zinc Oxide 0.98%

INACTIVE INGREDIENT

Inactive ingredients:

Water,Cyclopentasiloxane, Glycerin,Phenyl Trimethicone,Butylene Glycol Dicaprylate/Dicaprate
Butylene Glycol,PEG-10 Dimethicone,Caprylyl Methicone,Pentylene Glycol,Niacinamide,Methylene Bis-Benzotriazolyl Tetramethylbutylphenol,Ethylhexyl Palmitate
Trimethylsiloxysilicate,Cetyl PEG/PPG-10/1 Dimethicone, Magnesium Sulfate,Boron Nitride,Diphenyl Dimethicone,
Acrylates/Stearyl Acrylate/Dimethicone Methacrylate Copolymer,Phytosteryl Isostearyl Dimer Dilinoleate,Biosaccharide Gum-1,Decyl Glucoside
Aluminum Hydroxide,Phenoxyethanol,Methyl Methacrylate Crosspolymer,Disteardimonium Hectorite,Triethoxycaprylylsilane,Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer
Tocopheryl Acetate,Silica Dimethyl Silylate,Ethylhexylglycerin,Allantoin,HDI/Trimethylol Hexyllactone Crosspolymer,Dimethicone/Vinyl Dimethicone Crosspolymer,Adenosine
Disodium EDTA,Propylene Glycol,Xanthan Gum,Pseudoalteromonas Ferment Extract,Aloe Barbadensis Leaf Juice Powder,Silica,Hydrolyzed Extensin,Althaea Rosea Flower Extract
Aloe Barbadensis Leaf Extract,Simmondsia Chinensis (Jojoba) Seed Oil,Argania Spinosa Kernel Oil,Iron Oxides (CI 77492),Iron Oxides (CI 77491),Iron Oxides (CI 77499)
Fragrance,Leontopodium Alpinum Extract,Citric Acid,Sodium Benzoate ,Potassium Sorbate

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

Image of carton

ESMIA AIR CUSHION LIGHT BEIGE 21 
titanium dioxide, octinoxate, zinc oxide powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72600-190
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.49 g  in 15 g
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) Octinoxate1.05 g  in 15 g
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION0.80 g  in 15 g
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72600-190-021 in 1 CARTON09/01/2018
1NDC:72600-190-0115 g in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35209/01/2018
Labeler - Bs Cosmetics Co.,ltd. (694791429)
Registrant - Bs Cosmetics Co.,ltd. (694791429)
Establishment
NameAddressID/FEIBusiness Operations
EYESOME. Co.,Ltd.557795360manufacture(72600-190)

Revised: 10/2018
Document Id: 234c5ec8-c856-423a-adaa-b49d53e3270f
Set id: 8fd9dbff-c826-451e-a46f-6446e09aae1d
Version: 1
Effective Time: 20181019
 
Bs Cosmetics Co.,ltd.