MINERAL WEAR OH SO RADIANT POWDER SPF 20- titanium dioxide, zinc oxide powder 
Physicians Formula 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.

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Drug Facts

Warnings:  For external use only

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

Keep out of reach of children.  If product is swallowed, Get medical help, or contact a poison control center right away.

Active Ingredients:  Titanium Dioxide 10.0%, Zinc Oxide 10.0%

Purpose:  Sunscreen

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MINERAL WEAR OH SO RADIANT POWDER  SPF 20
titanium dioxide, zinc oxide powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:31645-167
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 CATION - UNII:13S1S8SF37) ZINC CATION10 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
MICA (UNII: V8A1AW0880)  
TRICAPRYLIN (UNII: 6P92858988)  
BORON NITRIDE (UNII: 2U4T60A6YD)  
ZINC STEARATE (UNII: H92E6QA4FV)  
LAUROYL LYSINE (UNII: 113171Q70B)  
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
SAFFLOWER OIL (UNII: 65UEH262IS)  
PANAX GINSENG ROOT WATER (UNII: P9T4K47OM0)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:31645-167-021 in 1 BOX12/01/201312/31/2017
1NDC:31645-167-0110 g in 1 TRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35212/01/201312/31/2017
Labeler - Physicians Formula Inc (021261805)

Revised: 12/2018
Document Id: 7e1c6eb2-9130-947c-e053-2a91aa0a1afc
Set id: b896615e-03bb-49fb-9de4-79c4270cfd21
Version: 3
Effective Time: 20181228
 
Physicians Formula Inc