UV NATURAL 100 MINERAL SUNKILL RX 12G- zinc oxide , titanium dioxide powder 
N&B LAB.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: Zinc Oxide 17.9%, Titanium Dioxide 17.3%

INACTIVE INGREDIENT

Inactive ingredients: Mica, Silica, Bismuth Oxychloride, CI 77492, CI 77491, CI 77499, Quartz, Sapphire Powder

PURPOSE

Purpose: Sunscreen

WARNINGS

Warnings:

For external use only.

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

Stop use and ask a doctor if Rash or irritation develops and lasts

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

DESCRIPTION

Uses: Helps prevent sunburn, Higher SPF gives moresunburn protection.

Directions: Apply evenly before sun exposure as needed.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

UV NATURAL 100 MINERAL SUNKILL RX  12G
zinc oxide , titanium dioxide powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69058-040
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION2.14 g  in 12 g
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide2.07 g  in 12 g
Inactive Ingredients
Ingredient NameStrength
Mica (UNII: V8A1AW0880)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69058-040-0112 g in 1 CARTON; Type 0: Not a Combination Product12/01/201412/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35212/01/201412/01/2018
Labeler - N&B LAB.Co.Ltd (690332858)
Registrant - N&B LAB.Co.Ltd (690332858)
Establishment
NameAddressID/FEIBusiness Operations
Genicos Co., Ltd.688454362manufacture(69058-040)

Revised: 3/2019
 
N&B LAB.Co.Ltd