SMART SUNBLOCK PUFF- zinc oxide, titanium dioxide powder 
EASY POWDER 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 Ingredient: ZINC OXIDE 15.0%, TITANIUM DIOXIDE 10.2%

INACTIVE INGREDIENT

Inactive Ingredients: MICA, BISMUTH OXYCHLORIDE, SILICA, IRON OXIDES(CI 77492), 1,2-HEXANEDIOL, IRON OXIDES(CI 77491), IRON OXIDES(CI 77499), GLYCERYL CAPRYLATE, METHICONE

PURPOSE

Purpose: Sunscreen

WARNINGS

Warnings: For external use only Use only as directed Stop use and ask a doctor if rash or skin irritation occurs Do not use on damaged or broken skin When using this product, keep out of eyes. Rinse with water to remove Keep out of reach of children Store this product at room temperature

DESCRIPTION

Indications & usage: Help protecting skin from UV-ray (SPF50+, PA+++) Help prevent and relieve chapped or cracked skin

Directions: Whenever UV-ray protection is needed or at the makeup finish stage, use the puff to spread powder gently over face. Apply in daily skin care routine

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

SMART SUNBLOCK PUFF 
zinc oxide, titanium dioxide powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69242-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION1.05 g  in 7 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.71 g  in 7 g
Inactive Ingredients
Ingredient NameStrength
MICA (UNII: V8A1AW0880)  
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69242-010-021 in 1 CARTON06/15/201611/01/2019
1NDC:69242-010-017 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 finalpart35206/15/201611/01/2019
Labeler - EASY POWDER CO., LTD. (689060406)
Registrant - EASY POWDER CO., LTD. (689060406)
Establishment
NameAddressID/FEIBusiness Operations
EASY POWDER CO., LTD.689060406manufacture(69242-010)

Revised: 12/2019
Document Id: 6bb6cad4-7476-4b8f-96f9-9e97eb854f7e
Set id: 4d8cf4fb-ea47-459a-9288-78652ba1fb5b
Version: 2
Effective Time: 20191219
 
EASY POWDER CO., LTD.