FDA.reportPublic FDA data

Salt and Stone Sunscreen Lip Balm SPF 30

Manufacturer
Salt and Stone LLC
Effective date
2025-01-30
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:54:09

Label at a glance#

ProductSalt and Stone Sunscreen Lip Balm SPF 30
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 2 hours Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with Broad Spectrum SPF value of 15 or higher and other sun protection measures including: • Limit time in the sun, especially fro...

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) 8 %

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 ask 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 immediately.

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 2 hours

  • Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with Broad Spectrum SPF value of 15 or higher and other sun protection measures including: • Limit time in the sun, especially from 10am - 2pm. • Wear long-sleeved shirts, pants, hats, and sunglasses. Sun Protection Measures.
  • 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

Prunus Amygdalus Dulcis (Sweet Almond) Oil, Butyrospermum Parkii (Shea) Butter, Cera Flava (Beeswax), Simmondsia Chinensis (Jojoba) Seed Oil, Euphorbia Cerifera (Candelilla) Wax, Tocopheryl Acetate, Argania Spinosa Kernel (Argan) Oil, Copernicia Cerifera (Carnauba) Wax, Tocopherol, Glycine Soja (Soybean) Oil, Bisabolol, GlycerylCaprylate, Glyceryl Undecylenate, Triethoxycaprylylsilane

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

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
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71585-139-002025-02-01C16284748780-12cef2736-9d24-d83d-e063-dadaa90ab31fSalt & Stone Sunscreen Lip Balm SPF 30, 0.15 Oz.(4.3 g)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71585-139-00Salt and Stone Sunscreen Lip Balm SPF 304.3 g in 1 APPLICATORSTICK4.33

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71585-139SALT AND STONE SUNSCREEN LIP BALM SPF 30 (ZINC OXIDE) STICK [SALT AND STONE LLC]3Current NDC, Legacy NDC, 1 package rows20250201_b555aa10-1547-63cc-e053-2995a90ad20d.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71585-13971585-139-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALMOND OIL66YXD4DKO9IACT
SHEA BUTTERK49155WL9YIACT
CANDELILLA WAXWL0328HX19IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
CARNAUBA WAXR12CBM0EIZIACT
TOCOPHEROLR0ZB2556P8IACT
SOYBEAN OIL241ATL177AIACT
LEVOMENOL24WE03BX2TIACT
GLYCERYL MONOCAPRYLATETM2TZD4G4AIACT
GLYCERYL 1-UNDECYLENATEB68LJT9544IACT
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
Salt and Stone Sunscreen Lip Balm SPF 30ZINC OXIDESalt and Stone LLCb555aa10-1547-63cc-e053-2995a90ad20d2025-01-30WarningsExact identifier
ndc (package): 71585-139-00
ndc (product): 71585-139
ndc11 (package): 71585013900
spl id: 2cf61829-1665-442a-e063-6394a90aa35f
spl set id: b555aa10-1547-63cc-e053-2995a90ad20d

Reported adverse events (FAERS/openFDA)#

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