MW Talc-free Face Powder-2413,2696,2697,3835,3836; 71413-202

Mineral Wear Talc Free Mineral Face Powder by

Drug Labeling and Warnings

Mineral Wear Talc Free Mineral Face Powder by is a Otc medication manufactured, distributed, or labeled by Baja Fur, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

MINERAL WEAR TALC FREE MINERAL FACE POWDER SPF 16- titanium dioxide, zinc oxide powder 
Baja Fur, S.A. de C.V.

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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MW Talc-free Face Powder-2413,2696,2697,3835,3836; 71413-202

Principle Display Panel

MINERAL WEAR TALC FREE MINERAL FACE POWDER  SPF 16
titanium dioxide, zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71413-202
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	6 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	4.2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
BORON NITRIDE (UNII: 2U4T60A6YD)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICA (UNII: V8A1AW0880)
O-CYMEN-5-OL (UNII: H41B6Q1I9L)
FERRIC OXIDE RED (UNII: 1K09F3G675)
SQUALANE (UNII: GW89575KF9)
LAUROYL LYSINE (UNII: 113171Q70B)
KAOLIN (UNII: 24H4NWX5CO)
HYDRATED SILICA (UNII: Y6O7T4G8P9)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71413-202-02	1 in 1 CARTON	01/01/2018
1	NDC: 71413-202-01	9 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	01/01/2018

Labeler - Baja Fur, S.A. de C.V. (821533098)

Revised: 9/2021

Document Id: cd3c72f9-2a04-3a9e-e053-2995a90a0591

34390-5

Set id: cd3c6e34-488f-14c8-e053-2a95a90a5adc

Version: 1

Effective Time: 20210930