MINERAL WEAR TALC FREE MINERAL FACE POWDER SPF 16- titanium dioxide, zinc oxide powder 
Markwins Beauty Brands

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.

----------

MW Talc-Free Face Powder-2413,2697,3835; 69514-304

apply liberally 15 minutes before sun exposure
use a water resistant sunscreen if swimming or sweating
reapply at least every 2 hours
children under 6 months of age: Ask a doctor
Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
limit time in the sun, especially from 10 a.m. – 2 p.m.
wear long-sleeved shirts, pants, hats, and sunglasses

For external use only

Do not use on damage or broken skin

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

Stop use and ask a doctor if rash occurs

Mica, Squalane, Silica, Lauroyl Lysine, Kaolin, Boron Nitride, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, o-Cymen-5-ol, Tocopheryl Acetate. May Contain/Peut Contenir: Iron Oxides (CI 77491, CI 77492, CI 77499), Titanium Dioxide (CI 77891).

helps prevent sunburn
If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging cause by the sun

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

Sunscreen

Titanium Dioxide 6%

Zinc Oxide 4.2%

Package Label PDP

MINERAL WEAR TALC FREE MINERAL FACE POWDER  SPF 16
titanium dioxide, zinc oxide powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69514-304
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE6 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE4.2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69514-304-021 in 1 CARTON01/01/2023
1NDC:69514-304-019 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 finalpart35201/01/2023
Labeler - Markwins Beauty Brands (078890119)

Revised: 1/2023
Document Id: f30cc928-d60e-3431-e053-2a95a90a6800
Set id: f30cc918-e5ec-2f48-e053-2a95a90aa150
Version: 1
Effective Time: 20230124
 
Markwins Beauty Brands