THE HEALTHY POWDER- titanium dioxide, zinc oxide powder

The Healthy Powder by

Drug Labeling and Warnings

The Healthy Powder by is a Otc medication manufactured, distributed, or labeled by Physicians Formula, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Titanium dioxide 6%

Zinc oxice 4.2%

Purpose

Sunscreen

Uses

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

Warnings

For external use only

Do not use

on damaged 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

Keep out of reach of children

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

Directions

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

Other information

Protect this product from excessive heat and sun

Inactive ingredients

Mica, Squalane, Silica, Kaolin, Boron Nitride, Lauroyl Lysine, Evodia Rutaecarpa Fruit Extract*, Sodium Hyaluronate, Ascorbic Acid, Retinyl Palmitate, Tocopherol, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Triethoxycaprylylsilane, o-Cymen-5-ol, Water/Eau, Propanediol, Synthetic Fluorphlogopite, Tin Oxide, Aluminum Hydroxide. May Contain/Peut Contenir: Iron Oxides (CI 77491, CI 77492, CI 77499), Titanium Dioxide (CI 77891).

Questions or comments?

call toll-free 1-800-227-0333

PDP

INGREDIENTS AND APPEARANCE

THE HEALTHY POWDER 
titanium dioxide, zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 31645-211
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 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	6 g  in 100 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: 31645-211-01	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)