POWDER- zinc oxide 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

Zinc oxide 24.5%

Sunscreen Agent

Uses

Helps prevent sunburn

If used as directed with other sun protection measures (see Directions), decreases the risk of cancer and early skin aging caused by the sun

Warnings

For external use only.

Do not use on damage or broken skin.

When using this product: Avoid inhalation.

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 product is 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 docstor

Sun Protection Measures. Spendign time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regulary use a sunscreen with a Board 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

Inactive Ingredients:

Calcium Aluminunm Borosilicate, Silica, Ethylhexylglycerin, Sodium Dehydroacetate, Fragrance, Sea Salt, Ceramide NP, Ascorbyl Palmitate, Caprylic/Capric Triglyceride, Triethoxycaprylylsilane, Carica Papaya (Papaya) Fruit Extract, Mangifera Indica (Mango) Fruit Extract, Passiflora Incarnata Fruit Extract, Plumeria Acutifolia Flower Extrat, Psidium Guajava Fruit Extract, Iron Oxides

Other information

Protect this product from excessive heat and direct sun

Package

INGREDIENTS AND APPEARANCE

POWDER 
zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61354-017
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	24.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)	48.26 g  in 100 g
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)	25 g  in 100 g
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)	0.5 g  in 100 g
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)	0.5 g  in 100 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61354-017-01	1 in 1 CARTON	10/28/2021
1		100 g in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	10/28/2021

Labeler - Oxygen Development LLC (137098492)

Establishment
Name	Address	ID/FEI	Business Operations
Oxygen Development LLC		137098492	manufacture(61354-017)