FDA.reportPublic FDA data

PREMIUM SUNSCREEN

Manufacturer
SALT AND STONE | JOSHUA TREE PRODUCTS LLC
Effective date
2019-04-11
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 22:59:11

Label at a glance#

ProductPREMIUM SUNSCREEN SPF-30
Active ingredientZINC OXIDE, OCTINOXATE
Label structure10 sections

Indications and uses

HELPS PREVENT SUNBURN IF USED AS DIRECTED WITH OTHER SUN PROTECTION MEASURES (SEE DIRECTIONS) DESCREASES THE RISK OF SKIN CANCER AND EARLY 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 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 SUN SCREEN WITH A BROAD SPECTRUM OF SPF 15 OR HIGHER AND OTHER SUN PROTECTION MEASURES INCLUDING: LIMIT TIME IN THE SUN...

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

ZINC OXIDE 10%

OCTINOXATE 7%

PURPOSE

OTC - PURPOSE SECTION

SUNSCREEN

USES

INDICATIONS & USAGE SECTION

  • HELPS PREVENT SUNBURN
  • IF USED AS DIRECTED WITH OTHER SUN PROTECTION MEASURES (SEE DIRECTIONS) DESCREASES THE RISK OF SKIN CANCER AND EARLY 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 THIS RISK, REGULARLY USE A SUN SCREEN WITH A BROAD SPECTRUM OF SPF 15 OR HIGHER AND OTHER SUN PROTECTION MEASURES INCLUDING:

  • LIMIT TIME IN THE SUN, FROM 10 A.M. - 2 P.M.
  • WEAR LONG-SLEEVE SHIRTS, PANTS, HATS, AND SUNGLASSES
  • CHILDREN UNDER 6 MONTHS: ASK A DOCTOR

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

* ALOE BARBADENSIS JUICE, * COCOS NUCIFERA (COCONUT) OIL, * HELIANTHUS ANNUUS (SUNFLOWER) OIL, GLYCERYL STEARATE, * THEOBROMA CACAO (COCOA) BUTTER, * VITELLARIA PARADOX (SHEA) BUTTER, STEARIC ACID, CETEARYL ALCOHOL, SODIUM STEARYL LACTATE, * SIMMONDSIA CHINENSIS (JOJOBA) OIL, * CERA ALBA (BEESWAX), * VANILLA, PHENOXYETHANOL, XANTHAN GUM, * TOCOPHEROL (VITAMIN E), SODIUM CITRATE, HYDROXYETHYLCELLULOSE, CITRIC ACID

* 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71585-102-212021-01-29C16284748780-1ba0f9c33-25e4-a910-e053-dadaa90a0b85MINERAL BASED SALT & STONE PREMIUM SUNSCREEN SPF-30

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71585-102-21PREMIUM SUNSCREENSPF-3088 mL in 1 TUBELOTION883

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71585-102PREMIUM SUNSCREEN SPF-30 (ZINC OXIDE, OCTINOXATE) LOTION [SALT AND STONE]3Legacy NDC, 1 package rows20190412_f4f5db0a-1d8b-48fd-bdc2-a19308cdfe92.zip

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71585-10271585-102-21

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIM
OCTINOXATE4Y5P7MUD51ACTIB
ALOE VERA LEAFZY81Z83H0XIACT
COCONUT OILQ9L0O73W7LIACT
SUNFLOWER OIL3W1JG795YIIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
COCOA BUTTER512OYT1CRRIACT
SHEA BUTTERK49155WL9YIACT
STEARIC ACID4ELV7Z65APIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
SODIUM STEAROYL LACTYLATEIN99IT31LNIACT
JOJOBA OIL724GKU717MIACT
YELLOW WAX2ZA36H0S2VIACT
VANILLAQ74T35078HIACT
PHENOXYETHANOLHIE492ZZ3TIACT
XANTHAN GUMTTV12P4NEEIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
SODIUM CITRATE1Q73Q2JULRIACT
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)R33S7TK2EPIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT

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
58ef100b-ef4e-4388-90b2-5139dd4ae285f4f5db0a-1d8b-48fd-bdc2-a19308cdfe922019-04-11WarningsExact identifier
spl id: 58ef100b-ef4e-4388-90b2-5139dd4ae285
spl set id: f4f5db0a-1d8b-48fd-bdc2-a19308cdfe92

Reported adverse events (FAERS/openFDA)#

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