FDA.reportPublic FDA data

Salt and Stone Outdoor Voices SPF 50

Manufacturer
Salt & Stone, Inc.
Effective date
2023-10-28
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:58:20

Label at a glance#

ProductSalt and Stone Outdoor Voices 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 Spenidng 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...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide (Non-Nano) 24%

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.

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.
  • Sun Protection Measures Spenidng 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 undre 6 months: Ask a doctor.

Other Information

SPL UNCLASSIFIED SECTION

Protect this product from excess heat and direct sun.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Butyloctyl Salicylate, Cera Alba*, Cocos Nucifera (Coconut) Oil*, Copernicia Cerifera (Carnauba) Wax*, Curcuma Longa (Turmeric) Root Extract, Ethylhexyl Methoxycrylene, Helianthus Annuus (Sun flower) Seed Oil*, Iron Oxides, Mica, Silica Simmondsia Chinensis (Jojoba) Seed Oil*, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate, Triethoxycaprylylsilane, Vegetable Oil*. *Organic Ingredient

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

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
71585-143-002025-01-30C16284748780-12cef2736-b51d-d83d-e063-dadaa90ab31fSalt & Stone Outdoor Voices SPF 50

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71585-143-00Salt and Stone Outdoor Voices SPF 5015 g in 1 TUBESTICK152

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71585-143SALT AND STONE OUTDOOR VOICES SPF 50 (ZINC OXIDE) STICK [SALT & STONE, INC.]21 package rows20231030_bb864d1e-a7d6-4a47-b9ed-6f84a4abd9e4.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71585-14371585-143-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
CORN OIL8470G57WFMIACT
WHITE WAX7G1J5DA97FIACT
JOJOBA OIL724GKU717MIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
COCONUT OILQ9L0O73W7LIACT
CARNAUBA WAXR12CBM0EIZIACT
TURMERIC856YO1Z64FIACT
ETHYLHEXYL METHOXYCRYLENES3KFG6Q5X8IACT
SUNFLOWER OIL3W1JG795YIIACT
FERRIC OXIDE RED1K09F3G675IACT
MICAV8A1AW0880IACT
COCOA BUTTER512OYT1CRRIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
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
08c1ad00-de03-625d-e063-6394a90a9357bb864d1e-a7d6-4a47-b9ed-6f84a4abd9e42023-10-28WarningsExact identifier
spl id: 08c1ad00-de03-625d-e063-6394a90a9357
spl set id: bb864d1e-a7d6-4a47-b9ed-6f84a4abd9e4

Reported adverse events (FAERS/openFDA)#

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