THE HEALTHY POWDER SPF16- 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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THE HEALTHY POWDER SPF16
titanium dioxide, zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:31645-204
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	4.2 g in 1 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	6 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
KAOLIN (UNII: 24H4NWX5CO)
LAUROYL LYSINE (UNII: 113171Q70B)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
TOCOPHEROL (UNII: R0ZB2556P8)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SQUALANE (UNII: GW89575KF9)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
TETRADIUM RUTICARPUM FRUIT (UNII: Q413WWJ3X9)
STANNIC OXIDE (UNII: KM7N50LOS6)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PROPANEDIOL (UNII: 5965N8W85T)
WATER (UNII: 059QF0KO0R)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
MICA (UNII: V8A1AW0880)
BORON NITRIDE (UNII: 2U4T60A6YD)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
O-CYMEN-5-OL (UNII: H41B6Q1I9L)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:31645-204-01	7.8 g in 1 CONTAINER; Type 0: Not a Combination Product	01/01/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	01/01/2019

Labeler - Physicians Formula, Inc (021261805)

PDP