DRUG FACTS

Active Ingredients

Zinc Oxide (Non-Nano) 24%

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 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.
Sun Protection Measures Spenidng time in the sun increases the risk of skin cancer and early skin aging. To decrease the risk, regularly use: a sunscreen with a broad-spectrum SPF of 15 or higher, and sun protection measures including:
Limiting time in the sun, especially from 10AM - 2PM.
Wear long-sleeved shirts, pants, hats, and sunglasses.

Children undre 6 months: Ask a doctor.

Other Information

Protect this product from excess heat and direct sun.

Inactive Ingredients

Butyloctyl Salicylate, Cera Alba*, Cocos Nucifera (Coconut) Oil*, Copernicia Cerifera (Carnauba) Wax*, Curcuma Longa (Turmeric) Root Extract, Ethylhexyl Methoxycrylene, Helianthus Annuus (Sun flower) Seed Oil*, Iron Oxides, Mica, Silica Simmondsia Chinensis (Jojoba) Seed Oil*, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate, Triethoxycaprylylsilane, Vegetable Oil*. *Organic Ingredient

Package Labeling:

Label

SALT AND STONE OUTDOOR VOICES SPF 50
zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71585-143
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	240 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
CORN OIL (UNII: 8470G57WFM)
WHITE WAX (UNII: 7G1J5DA97F)
JOJOBA OIL (UNII: 724GKU717M)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
COCONUT OIL (UNII: Q9L0O73W7L)
CARNAUBA WAX (UNII: R12CBM0EIZ)
TURMERIC (UNII: 856YO1Z64F)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
SUNFLOWER OIL (UNII: 3W1JG795YI)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MICA (UNII: V8A1AW0880)
COCOA BUTTER (UNII: 512OYT1CRR)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:71585-143-00	15 g in 1 TUBE; Type 0: Not a Combination Product	04/01/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	04/01/2023

Labeler - Salt & Stone, Inc. (080683697)

Salt & Stone Outdoor Voices SPF 50