Salt & Stone Natural Mineral Sunscreen Lotion SPF 50, 3 fl.Oz.(88 mL)

Salt and Stone Natural Mineral Sunscreen SPF 50 by

Drug Labeling and Warnings

Salt and Stone Natural Mineral 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]

SALT AND STONE NATURAL MINERAL SUNSCREEN SPF 50- zinc oxide lotion 
Salt and Stone LLC

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Salt & Stone Natural Mineral Sunscreen Lotion SPF 50, 3 fl.Oz.(88 mL)

Drug Facts

Active Ingredients

Zinc Oxide (Non-Nano) 22.0%

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.

Stop use and see a doctor if rash occurs.

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 value of 15
or higher, and other sun protection measures including:
Limiting time in the sun, especially from 10AM – 2PM.
Wearing 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

Caprylic/Capric Triglyceride, Ricinus Communis (Castor) Seed Oil, Cera Alba (Beeswax), Coco-Caprylate/Caprate, Polyglyceryl-3 Polyricinoleate, Cocos Nucifera (Coconut Oil), Tocopherol Acetate (Vitamin E), Helianthus Annuus (Sunflower) Seed Oil, Rosa Canina (Rosehip) Seed Oil, Persea Gratissima (Avocado) Oil, Isostearic Acid.

Package Label

SALT AND STONE NATURAL MINERAL SUNSCREEN SPF 50 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71585-137
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	220 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CASTOR OIL (UNII: D5340Y2I9G)
YELLOW WAX (UNII: 2ZA36H0S2V)
COCO-CAPRYLATE (UNII: 4828G836N6)
COCONUT OIL (UNII: Q9L0O73W7L)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SUNFLOWER OIL (UNII: 3W1JG795YI)
ROSA MOSCHATA OIL (UNII: J99W255AWF)
AVOCADO OIL (UNII: 6VNO72PFC1)
ISOSTEARIC ACID (UNII: X33R8U0062)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71585-137-00	88 mL in 1 TUBE; Type 0: Not a Combination Product	08/01/2019	08/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	08/01/2019	08/01/2023

Labeler - Salt and Stone LLC (080683697)

Revised: 10/2023

Document Id: 07fd4ec5-2e21-f584-e063-6394a90a32d1

34390-5

Set id: b5542dc6-f87a-3350-e053-2995a90a4dea

Version: 2

Effective Time: 20231018