MINERAL SUNSCREEN - WATER RESISTANT

Manufacturer
SALT AND STONE
Effective date
2019-07-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:59:57

Label at a glance#

ProductMINERAL SUNSCREEN - WATER RESISTANT SPF-50
Active ingredientZINC OXIDE
Label structure9 sections

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 • Sun Protection Measures. Spending time in the sun increases your 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 & other sun protection measures including: • Limit time i...

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

ZINC OXIDE 22.8%

PURPOSE

OTC - PURPOSE SECTION

SUNSCREEN

USE

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 on damaged or broken skin
When using this product keep out of eyes. Rinse with water to remove.
Stop use and ask a doctor if rash occurs.


OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN.

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 2 hours
• Sun Protection Measures.
Spending time in the sun increases your 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 & other sun protection measures including:
• Limit time in the sun, especially from 10am - 2pm.
• Wear long-sleeve shirts, pants, hats, and sunglasses.
• Children under 6 months: Ask a doctor

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Coco-Caprylate/Caprate, Polyglyceryl-3 Polyricinoleate, Isostearic Acid, Caprilic/capric triglyceride, Dimethicone, Octyl Palmitate, Butylene Glycol, PEG-30 Dipolyhydroxystearate, Cera Alba (Beeswax), Glycerol, Polyethylene, Rosa Canina (Rosehip) Seed Oil, Persea Gratissima (Avocado) Oil, Hyaluronic Acid, Ethylhexylglycerin, Phenoxyethanol, Glyceryl Oleate, Xanthan gum.

OTHER INFORMATION

OTHER SAFETY INFORMATION

  • PROTECT THIS PRODUCT FROM EXCESSIVE HEAT AND DIRECT SUN

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

USA SPF Lotion_50_1USA SPF Lotion_50_1

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
71585-109-212021-01-29C16284748780-1ba0f9c33-5a2a-a910-e053-dadaa90a0b85SALT & STONE MINERAL SUNSCREEN SPF-50 - WATER RESISTANT

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71585-109-21MINERAL SUNSCREEN - WATER RESISTANTSPF-5088 mL in 1 TUBELOTION881

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71585-109MINERAL SUNSCREEN - WATER RESISTANT SPF-50 (ZINC OXIDE) LOTION [SALT AND STONE]1Legacy NDC, 1 package rows20190730_6a63e108-65f7-49b5-8ed1-5016d446ec2e.zip

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71585-10971585-109-21

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

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
9020ca2c-0a1d-46f6-aca6-c15aa07548a56a63e108-65f7-49b5-8ed1-5016d446ec2e2019-07-28WarningsExact identifier
spl id: 9020ca2c-0a1d-46f6-aca6-c15aa07548a5
spl set id: 6a63e108-65f7-49b5-8ed1-5016d446ec2e

Reported adverse events (FAERS/openFDA)#

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