FDA.reportPublic FDA data

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

Manufacturer
Salt and Stone LLC
Effective date
2020-11-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:05:11

Label at a glance#

ProductSalt and Stone Natural Mineral Sunscreen SPF 50
Active ingredientZINC OXIDE
Label structure7 sections

Indications and 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.

Dosage and administration

• 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 inclu...

Storage and handling

Protect this product from excess heat and direct sun.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide (Non-Nano) 22.0%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

• 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

WARNINGS SECTION

For external use only.

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin.

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

Stop use and see a doctor if rash occurs.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If product is swallowed, get medical help or contact a poison control center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

• 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

STORAGE AND HANDLING SECTION

Protect this product from excess heat and direct sun.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71585-13771585-137-00

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CASTOR OILD5340Y2I9GIACT
YELLOW WAX2ZA36H0S2VIACT
COCO-CAPRYLATE4828G836N6IACT
COCONUT OILQ9L0O73W7LIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
SUNFLOWER OIL3W1JG795YIIACT
ROSA MOSCHATA OILJ99W255AWFIACT
AVOCADO OIL6VNO72PFC1IACT
ISOSTEARIC ACIDX33R8U0062IACT
ZINC OXIDESOI2LOH54ZACTIM

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
07fd4ec5-2e21-f584-e063-6394a90a32d1b5542dc6-f87a-3350-e053-2995a90a4dea2023-10-18WarningsExact identifier
spl set id: b5542dc6-f87a-3350-e053-2995a90a4dea

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.