SONATURAL POW DER4ROOM COVER FIXING CUSHION 23.5- titanium dioxide, octinoxate, octisalate, octocrylene, zinc oxide powder 
Sonatural Global 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 9.0%, Ethylhexyl Methoxycinnamate 7.0%, Ethylhexyl Salicylate 4.8%, Octocrylene 2.0%, Zinc Oxide 2.0%

INACTIVE INGREDIENT

Inactive ingredients: Water, Cyclopentasiloxane, Cyclohexasiloxane, C12-15 Alkyl benzoate, Glycerin, PEG-30 Dipolyhydroxystearate, Niacinamide, Trimethylsiloxysilicate, CI 77492, PEG-10 Dimethicone, Butylene Glycol, Quaternium-18 Bentonite, Sodium Chloride, Dimethicone, CI 77491, Triethoxycaprylylsilane, Chlorphenesin, Aluminum Hydroxide, CI 77499, Phenoxyethanol, Copernicia Cerifera (Carnauba) Wax, Ozokerite, Parfum, ADENOSINE, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Glycine Soja (Soybean) Sterols, PEG-5 Rapeseed Sterol, Ceteth-4, Cholesterol, Bacillus/Soybean Ferment Extract, Portulaca Oleracea Extract, Hydrolyzed Adansonia Digitata Extract, Tocopheryl Acetate, Potassium Cetyl Phosphate, Pyridoxine HCl, Magnesium Ascorbyl Phosphate, Panthenol, Retinyl Palmitate, Linoleic Acid, Carbomer, Caprylyl Glycol, Disodium EDTA, Biotin, Linolenic Acid

PURPOSE

Purpose: Sunscreen

WARNINGS

Warnings: 1. If the following symptoms occur, discontinue use and consult a dermatologist: 1) Red spots, swelling, itchiness, or irritation upon use 2) If above symptoms occur when skin is in direct sunlight 2. Do not use on open wounds and on skin with eczema or dermatitis 3. Storage instructions: 1) Close lid tightly after each use 2) Keep out of reach of children 3) Store at room temperature away from direct sunlight 4. SPF of this product was measured by the measurement of SPF and UVA protection rating was measured by the measurement of UVA protection effect according to the Regulations on the Examination of Functional Cosmetics.

DESCRIPTION

Indications & Usage: After using sunscreen, put adequate amount and pat onto face as needed for coverage. Before use it, pull off the inner cap, remove the sticker and then press the puff onto cushion.

Dosage & Administration: Take up adequate amount onto puff and apply to skin evenly.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

SONATURAL POW DER4ROOM COVER FIXING CUSHION 23.5 
titanium dioxide, octinoxate, octisalate, octocrylene, zinc oxide powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71322-110
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide1.35 g  in 15 g
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) Octinoxate1.05 g  in 15 g
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate0.72 g  in 15 g
Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) Octocrylene0.3 g  in 15 g
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION0.3 g  in 15 g
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71322-110-021 in 1 CARTON03/02/201712/31/2018
1NDC:71322-110-0115 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 finalpart35203/02/201712/31/2018
Labeler - Sonatural Global Co.,Ltd (694818511)
Registrant - Sonatural Global Co.,Ltd (694818511)
Establishment
NameAddressID/FEIBusiness Operations
Hankook Cosmetics Manufacturing Co.,Ltd_Eumseong Factory688235645manufacture(71322-110)

Revised: 1/2019
 
Sonatural Global Co.,Ltd