Salt and Stone Tinted Sunscreen SPF 50: Package Insert and Label Information

SALT AND STONE TINTED SUNSCREEN SPF 50- zinc oxide stick
Salt and Stone LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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.

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
  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.
• 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

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 DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (ZINC CATION) ZINC CATION 0.2405 g in 1 g

Inactive Ingredients Ingredient Name Strength ARGAN OIL YELLOW WAX LEVOMENOL SHEA BUTTER COCONUT OIL CARNAUBA WAX SUNFLOWER OIL FERRIC OXIDE RED MICA SILICON DIOXIDE JOJOBA OIL COCOA BUTTER .ALPHA.-TOCOPHEROL ACETATE TRIETHOXYCAPRYLYLSILANE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:71585-138-00 15 g in 1 APPLICATOR None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 11/01/2020

Labeler — Salt and Stone LLC (080683697)

Revised: 11/2020 Salt and Stone LLC