SALT AND STONE TINTED SUNSCREEN SPF 50- zinc oxide stick

Salt and Stone Tinted Sunscreen SPF 50 by

Drug Labeling and Warnings

Salt and Stone Tinted Sunscreen SPF 50 by is a Otc medication manufactured, distributed, or labeled by Salt and Stone LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Zinc Oxide (Non-Nano) 24. 05%

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.

on damaged or broken skin. Do not use

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

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.
• After 80 minutes of swimming or sweating, Immediately after towel drying, At least every two ( 2 ) hours. Reapply:
  
  
  
• Spending 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. Sun Protection Measures
  
  
  
• Children under 6 months: Ask a doctor.

Other Information

Protect this product from excess heat and direct sun.

Inactive Ingredients

Argania Spinosa Kernel Oil, Beeswax,* Bisabolol, Butyrospermum Parkii (Shea) Butter, Cocos Nucifera (Coconut) Oil,* Copernicia Cerifera (Carnauba) Wax,* Helianthus Annuus (Sunflower) Seed Oil,* Iron Oxides, Mica, Silica, Simmondsia Chinensis (Jojoba) Seed Oil,* Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate, Triethoxycaprylylsilane.

Package label

INGREDIENTS AND APPEARANCE

SALT AND STONE TINTED SUNSCREEN SPF 50 
zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71585-138
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	0.2405 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ARGAN OIL (UNII: 4V59G5UW9X)
YELLOW WAX (UNII: 2ZA36H0S2V)
LEVOMENOL (UNII: 24WE03BX2T)
SHEA BUTTER (UNII: K49155WL9Y)
COCONUT OIL (UNII: Q9L0O73W7L)
CARNAUBA WAX (UNII: R12CBM0EIZ)
SUNFLOWER OIL (UNII: 3W1JG795YI)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MICA (UNII: V8A1AW0880)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
JOJOBA OIL (UNII: 724GKU717M)
COCOA BUTTER (UNII: 512OYT1CRR)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71585-138-00	15 g in 1 APPLICATOR; Type 0: Not a Combination Product	11/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	11/01/2020

Labeler - Salt and Stone LLC (080683697)