sunscreen powder by Guangzhou Fantesy Biotechnology Co.,Ltd SUNSCREEN POWDER powder

sunscreen powder by

Drug Labeling and Warnings

sunscreen powder by is a Otc medication manufactured, distributed, or labeled by Guangzhou Fantesy Biotechnology Co.,Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Zinc Oxide 25%

Purpose

Sunscreen

Uses

Helps prevent sunburn

Warnings

For external use only.
Do not use on damaged or broken skin.
Stop use and ask a doctor if rash occurs.
When using this product, keep out of eyes. Rinse with water to remove.
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center immediately.

Do not use

Do not use on damaged or broken skin.

When using this product

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

Stop use

Stop use and ask a doctor if rash occurs.

Keep out of

Keep out of reach of children.

Directions

Apply liberally to face at least 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

Other information

Protect this product from excessive heat and direct sun.

Inactive ingredients

Sericite, Mica, and Silica.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SUNSCREEN POWDER 
sunscreen powder powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83447-001
Route of Administration	CUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	25 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MICA (UNII: V8A1AW0880)
PYROPHYLLITE (UNII: 1U9X05245H)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83447-001-01	3.5 g in 1 BOX; Type 0: Not a Combination Product	05/05/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	05/05/2023

Labeler - Guangzhou Fantesy Biotechnology Co.,Ltd (619047084)

Establishment
Name	Address	ID/FEI	Business Operations
Guangzhou Fantesy Biotechnology Co.,Ltd		619047084	manufacture(83447-001)