Label: THE HEALTHY POWDER SPF16- titanium dioxide, zinc oxide powder
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Contains inactivated NDC Code(s)
NDC Code(s): 31645-204-01 - Packager: Physicians Formula, Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated June 17, 2019
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INGREDIENTS AND APPEARANCE
THE HEALTHY POWDER SPF16
titanium dioxide, zinc oxide powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:31645-204 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 Inactive Ingredients Ingredient Name Strength 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:31645-204-01 7.8 g in 1 CONTAINER; Type 0: Not a Combination Product 01/01/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 01/01/2019 Labeler - Physicians Formula, Inc (021261805)
