ELF PERSONAL BLEND FOUNDATION SPF 15 - titanium dioxide powder 
Shanghai Justking Enterprise 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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Drug Fact

Active Ingredient:

Zinc Oxide: 15%

Titanium Dioxide: 10%

Purpose:

Sunscreen

Uses:

Help prevent Sunburn

Warning:

For external use only

When Using This Product:

Avoid contact with eyes. If contact occurs, rinse thoroughly with water

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 immediately

Directions:

Move the dial opening to desired color and shake the Personal Blend Foundation SPF 15 back and forth to get excess powder loose onto the tray. Gently glide over the powder with a brush to grab the powder, bring your brush to the cap to work in the powder to the brush, then tap off any excess. Apply to the areas of the face that need coverage by working into the skin in a circular motion. When not in use, move the dial opening in between two colors so the dial opening is closed.

Other Imformation:

Store at room temperature 15-30C (59-86F)

Inactive Ingredient:

Mica, Fragrance, Bismuth Oxychloride, Tocopheryl Acetate, Boron Nitride

May contain:

Iron Oxides (CI 77491, CI 77492, CI 77499), Manganese Violet (CI 77742), Ultramarine Blue (CI 77007)

labellabel

ELF PERSONAL BLEND FOUNDATION SPF 15 
titanium dioxide powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76166-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE10 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE15 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
MICA (UNII: V8A1AW0880)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76166-001-012.8 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35205/01/2011
Labeler - Shanghai Justking Enterprise Co. Ltd. (421267459)
Establishment
NameAddressID/FEIBusiness Operations
Shanghai Justking Enterprise Co. Ltd.421267459manufacture

Revised: 5/2011
Document Id: 2b8b55cf-347b-4675-bf90-ce0e67071052
Set id: d71ecb0e-bce7-4f96-ad6c-64bef7dde9a3
Version: 1
Effective Time: 20110501
 
Shanghai Justking Enterprise Co. Ltd.