PREMIUM SUNSCREEN

Manufacturer
SALT AND STONE
Effective date
2019-07-28
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 22:59:57

Label at a glance#

ProductPREMIUM SUNSCREEN SPF-30
Active ingredientZINC OXIDE
Label structure10 sections

Dosage and administration

For use on children less than 6 months of age, consult a health care practitioner. Apply liberally/generously (and evenly) 15 minutes before sun exposure. Reapply at least every 2 hours. Reapply after 80 minutes of swimming or sweating. Reapply immediately after towel drying. Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly ...

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

ZINC OXIDE 20%

PURPOSE

OTC - PURPOSE SECTION

SUNSCREEN

USE

INDICATIONS & USAGE SECTION

HELPS PREVENT SUNBURN.

WARNINGS

WARNINGS SECTION

FOR EXTERNAL USE ONLY.

DO NOT USE ON DAMAGED OR BROKEN SKIN.

IF RASH OCCURS, DISCONTINUE USE AND CONSULT A HEALTH CARE PRACTITIONER.

WHEN USING THIS PRODUCT: KEEP OUT OF EYES. RINSE WITH WATER TO REMOVE.

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

For use on children less than 6 months of age, consult a health care practitioner. Apply liberally/generously (and evenly) 15 minutes before sun exposure. Reapply at least every 2 hours. Reapply after 80 minutes of swimming or sweating. Reapply immediately after towel drying. Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF 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.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

*Aloe Barbadensis Juice, *Cera Alba (Beeswax), Cetearyl Alcohol, Citric Acid, *Cocos Nucifera (Coconut) Oil, Glyceryl Stearate, *Helianthus Annuus (Sunflower) Seed Oil, Hydroxyethylcellulose, Phenoxyethanol, *Simmondsia Chinesnsis (Jojoba) Oil, Sodium Citrate, Sodium Stearoyl Lactylate, Stearic Acid, *Theobroma Cacao (Cocoa) Butter, *Tocopherol (Vitamin E), *Vanilla, *Vitellaria Paradox (Shea) Butter, Xanthan Gum

*Certified Organic

OTHER INFORMATION

OTHER SAFETY INFORMATION

  • PROTECT THIS PRODUCT FROM EXCESSIVE HEAT AND DIRECT SUN

QUESTIONS OR COMMENTS?

OTC - QUESTIONS SECTION

CALL TOLL FREE 888 952 4250

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

01b LBL_S&S_Premium Sunscreen SPF-30_US01b LBL_S&S_Premium Sunscreen SPF-30_US

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
71585-105-212021-01-29C16284748780-1ba0f9c33-5a2d-a910-e053-dadaa90a0b85SALT & STONE PREMIUM SUNSCREEN SPF-30

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71585-105-21PREMIUM SUNSCREENSPF-3088 mL in 1 TUBELOTION884

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71585-105PREMIUM SUNSCREEN SPF-30 (ZINC OXIDE) LOTION [SALT AND STONE]4Legacy NDC, 1 package rows20190730_a3732451-ac84-4c56-8e01-3c92c3e857b3.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
71585-10571585-105-21

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
d341c489-cabe-41a5-a568-7635b89ecd12a3732451-ac84-4c56-8e01-3c92c3e857b32019-07-28WarningsExact identifier
spl id: d341c489-cabe-41a5-a568-7635b89ecd12
spl set id: a3732451-ac84-4c56-8e01-3c92c3e857b3

Reported adverse events (FAERS/openFDA)#

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