ORGANIC WEAR 100% NATURAL ORIGIN TINTED MOISTURIZER SPF 15- titanium dioxide cream 
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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OW Tinted Moisturizer 2154-2157

Carton PDP

ORGANIC WEAR 100% NATURAL ORIGIN TINTED MOISTURIZER  SPF 15
titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:31645-145
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE3.95 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
CAMELLIA SINENSIS SEED OIL (UNII: O5R6DK2M9K)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
AVOCADO OIL (UNII: 6VNO72PFC1)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
TALC (UNII: 7SEV7J4R1U)  
SHEA BUTTER (UNII: K49155WL9Y)  
GARCINIA INDICA SEED BUTTER (UNII: US2H3D7800)  
ALGINIC ACID (UNII: 8C3Z4148WZ)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:31645-145-021 in 1 BOX02/01/200908/09/2022
1NDC:31645-145-0144 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35202/01/200908/09/2022
Labeler - Physicians Formula Inc (021261805)

Revised: 8/2022
 
Physicians Formula Inc