POWDER- titanium dioxide powder

Powder by

Drug Labeling and Warnings

Powder by is a Otc medication manufactured, distributed, or labeled by Oxygen Development LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Titanium Dioxide

Purpose

Sunscreen

Uses

Helps prevent sunburn.

Warnings

For external use only

Do not use

Do not use on damaged or broken skin

When using

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

Keep out of reach of children

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: ask a doctor

Other Information

Protect this product from excessive heat and direct sun In the unlikely event of an adverse reaction, please contact 1.866.PUR.0022.

Inactive Ingredient

Mica, Caprylic/Capric Triglyceride, Boron Nitride, Bismuth Oxychloride, Zinc Stearate, Magnesium Silicate, Sodium Starch Octenylsuccinate, Mannitol, Sodium Gluconate, Citric Acid, Sodium Citrate, Waltheria Indica Leaf Extract, Dextrin, Ferulic Acid, Lactic Acid (L), Butyrospermum Parkii (Shea) Butter, Retinol, Ceramide AP, Silica, Tocopheryl Acetate, Aqua, Glucosamine HCI, Pisum Sativum (Pea) Extract, Bambusa Vulgaris Leaf/Stem Extract, Magnesium Carbonate, Iron Oxides (CI 77491, CI 77492, CI 77499), May Contain: Titanium Dioxide (CI 77891), Ultramarines (CI 77007).

Package label - Principal display panel

INGREDIENTS AND APPEARANCE

POWDER 
titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61354-118
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
FERRIC OXIDE RED (UNII: 1K09F3G675) (FERRIC OXIDE RED - UNII:1K09F3G675)	FERRIC OXIDE RED	1.75 mg  in 100 mg
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	10 mg  in 100 mg

Inactive Ingredients
Ingredient Name	Strength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)	8 mg  in 100 mg
MAGNESIUM SILICATE (UNII: 9B9691B2N9)	2 mg  in 100 mg
MANNITOL (UNII: 3OWL53L36A)	1.67 mg  in 100 mg
BORON NITRIDE (UNII: 2U4T60A6YD)	8 mg  in 100 mg
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)	0.5 mg  in 100 mg
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)	1.89 mg  in 100 mg
MICA (UNII: V8A1AW0880)	53.09 mg  in 100 mg
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)	10 mg  in 100 mg
ZINC STEARATE (UNII: H92E6QA4FV)	2.8 mg  in 100 mg

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61354-118-02	1 in 1 CARTON	10/27/2023
1	NDC: 61354-118-01	100 mg in 1 CUP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	10/27/2023

Labeler - Oxygen Development LLC (137098492)

Establishment
Name	Address	ID/FEI	Business Operations
Oxygen Development LLC		137098492	manufacture(61354-118)