DRUG FACTS

Active Ingredients

Zinc Oxide (Non-Nano) 22.5%

Purpose

Sunscreen

Uses

Hepls prevent sunburn.
If used as directed with other sun protection measures (see directions), decreases the risk of skin cancer and early skin aging caused 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.

If rash occurs

stop use and see a doctor.

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.
Reapply:
After 80 minutes of swimming or sweating,
Immediately after towel drying.
At least every two (2) hours.
Spending time in the sun increases the risk of skin cancer and early skin aging. To decrease the risk, regularly use: a suscreen with a broad-spectrum measures including: Sun Protection Measures
Limiting time in the sun, especially from 10AM - 2PM.
Wear long-sleeved shirts, pants, hats, and sunglasses.
Children under 6 months: Ask a doctor.

Other Information

Protect this product from excess heat and direct sun.

Inactive Ingredients

(Shea) Butter, Cera Alba (Beeswax)*, (Carnauba) Wax,* (Coconut) Oil,* (Sunflower) Seed Oil,* Butyrospermum ParkiiCopernicia CeriferaCocos NuciferaHelianthus AnnuusMica, Silica, Simmondsia Chinensis (Jojoba) Seed Oil,* Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate.

*Organic Ingredient

Package Labeling:

Outer Package2 Inner Package2

SALT AND STONE SPF 30 SUNSCREEN STICK
zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71585-141
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	225 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
SHEA BUTTER (UNII: K49155WL9Y)
YELLOW WAX (UNII: 2ZA36H0S2V)
CARNAUBA WAX (UNII: R12CBM0EIZ)
COCONUT OIL (UNII: Q9L0O73W7L)
SUNFLOWER OIL (UNII: 3W1JG795YI)
MICA (UNII: V8A1AW0880)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
JOJOBA OIL (UNII: 724GKU717M)
COCOA BUTTER (UNII: 512OYT1CRR)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:71585-141-00	15 g in 1 TUBE; Type 0: Not a Combination Product	09/22/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	09/22/2021

Labeler - Salt and Stone (080683697)

Salt & Stone SPF 30 Sunscreen stick