PERSONAL BLEND FOUNDATION by J. A. Cosmetics U.S. INC / Shanghai J. A. Cosmetics Trading CO., LTD.

PERSONAL BLEND FOUNDATION by

Drug Labeling and Warnings

PERSONAL BLEND FOUNDATION by is a Otc medication manufactured, distributed, or labeled by J. A. Cosmetics U.S. INC, Shanghai J. A. Cosmetics Trading CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PERSONAL BLEND FOUNDATION SPF 15- titanium dioxide, zinc oxide powder 
J. A. Cosmetics U.S. INC

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.

----------

Active Ingredients:

​TITANIUM DIOXIDE (10%)

ZINC OXIDE (15%)

Purpose:

SUNSCREEN

Uses:

HELPS PREVENT SUNBURN

Warning:

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 occurs.

KEEP OUT OF REACH OF CHILDREN.

Directions:

  • APPLY LIBERALLY AS NEEDED 15 TO 20 MINUTES BEFORE SUN EXPOSURE. REAPPLY AS NEEDED OR AFTER SWIMMING OR TOWEL DRYING.

Inactive Ingredient:

MICA, BISMUTH OXYCHLORIDE, PARAFFINUM LIQUIDUM (MINERAL OIL), DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, SILICA, SODIUM DEHYDROACETATE, TOCOPHERYL ACETATE (VE)

May Contain: Iron Oxides (CI 77491, CI 77492, CI 77499), MANGANESE VIOLET (CI 77742), ULTRAMARINES (CI 77007)

Personal Blend Foundation SPF 15

PERSONAL BLEND FOUNDATION  SPF 15
titanium dioxide, zinc oxide powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 76354-104
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   in 100 g
Inactive Ingredients
Ingredient NameStrength
MICA (UNII: V8A1AW0880)  
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
MINERAL OIL (UNII: T5L8T28FGP)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
MANGANESE VIOLET (UNII: 72M48QQV8Q)  
ULTRAMARINE BLUE (UNII: I39WR998BI)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 76354-104-218 g in 1 CONTAINER; Type 0: Not a Combination Product10/10/201312/31/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35210/10/201312/31/2017
Labeler - J. A. Cosmetics U.S. INC (186705047)

Revised: 3/2014
 
J. A. Cosmetics U.S. INC