FDA.reportPublic FDA data

Salt and Stone SPF 30 Sunscreen stick

Manufacturer
Salt and Stone
Effective date
2023-10-28
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:58:14

Label at a glance#

ProductSalt and Stone SPF 30 Sunscreen stick
Active ingredientZINC OXIDE
Label structure7 sections

Indications and uses

Hepls 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. Spending time in the sun increases the risk of skin cancer and early skin aging. To decrease the risk, regularly use: a suscreen with a broad-spectrum measures including: Sun Protection Measures Limiting time in the sun, especially from 10AM - 2PM. Wear lo...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide (Non-Nano) 22.5%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • Hepls 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.

Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin.

When using this product,

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove.

If rash occurs

stop use and see a doctor.

OTC - STOP USE SECTION

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.
  • Spending time in the sun increases the risk of skin cancer and early skin aging. To decrease the risk, regularly use: a suscreen with a broad-spectrum measures including: Sun Protection Measures
  • 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

SPL UNCLASSIFIED SECTION

Protect this product from excess heat and direct sun.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

(Shea) Butter, Cera Alba (Beeswax)*, (Carnauba) Wax,* (Coconut) Oil,* (Sunflower) Seed Oil,* Butyrospermum Parkii Copernicia Cerifera Cocos Nucifera Helianthus Annuus Mica, Silica, Simmondsia Chinensis (Jojoba) Seed Oil,* Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate.

*Organic Ingredient

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer Package2Outer Package2Inner Package2Inner Package2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71585-141-002025-01-30C16284748780-12cef2736-a493-d83d-e063-dadaa90ab31fSalt & Stone SPF 30 Sunscreen stick

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71585-141-00Salt and Stone SPF 30 Sunscreen stick15 g in 1 TUBESTICK152

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71585-141SALT AND STONE SPF 30 SUNSCREEN STICK (ZINC OXIDE) STICK [SALT AND STONE]2Legacy NDC, 1 package rows20231030_a7319501-214a-4cc9-8a0d-565909063d01.zip

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
71585-14171585-141-00

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
SHEA BUTTERK49155WL9YIACT
YELLOW WAX2ZA36H0S2VIACT
CARNAUBA WAXR12CBM0EIZIACT
COCONUT OILQ9L0O73W7LIACT
SUNFLOWER OIL3W1JG795YIIACT
MICAV8A1AW0880IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
JOJOBA OIL724GKU717MIACT
COCOA BUTTER512OYT1CRRIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
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
08c1a8af-2e10-682c-e063-6394a90a8892a7319501-214a-4cc9-8a0d-565909063d012023-10-28WarningsExact identifier
spl id: 08c1a8af-2e10-682c-e063-6394a90a8892
spl set id: a7319501-214a-4cc9-8a0d-565909063d01

Reported adverse events (FAERS/openFDA)#

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