FDA.reportPublic FDA data

SUNSCREEN

Manufacturer
SALT AND STONE | Filltech USA, LLC
Effective date
2019-05-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:59:31

Label at a glance#

ProductSUNSCREEN SPF-50 TINTED
Active ingredientZINC OXIDE
Label structure10 sections

Indications and uses

HELPS PREVENT SUNBURN

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. REAPPL AFTER 80 MINUTES OF SWIMMING OR SWEATING OR IMMEDIATELY AFTER TOWEL DRYING. REAPPLY 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 S...

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

ZINC OXIDE 22.5%

PURPOSE

OTC - PURPOSE SECTION

SUNSCREEN

USES

INDICATIONS & USAGE SECTION

  • HELPS PREVENT SUNBURN

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

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. REAPPL AFTER 80 MINUTES OF SWIMMING OR SWEATING OR IMMEDIATELY AFTER TOWEL DRYING. REAPPLY 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

* TYROSPERMUM PARKII (SHEA) BUTTER, * BEESWAX (CIRE D'ABIELLE), * COCOS NUCIFERA (COCONUT) OIL, SILICA, * COPERNICIA PRUNIFERA (CARNAUBA) WAX,* HELIANTHUS ANNUUS (SUNFLOWER) OIL, IRON OXIDE, MICA, SILICA, * SIMMONDSIA CHINENSIS (JOJOBA) OIL, * THEOBROMA CACAO (COCOA) BUTTER, VITAMIN E.

* 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 1 888 952 4250

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

01b LBL_Face Stick SPF-50 Tinted_US_front01b LBL_Face Stick SPF-50 Tinted_US_front

01b LBL_Face Stick SPF-50 Tinted_US_back01b LBL_Face Stick SPF-50 Tinted_US_back

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
71585-106-112023-01-30C16284748780-1f386c649-ad2b-0266-e053-dadaa90a7c1aMINERAL BASED SALT & STONE PREMIUM SUNSCREEN FACE STICK SPF-50 TINTED

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71585-106-11SUNSCREENSPF-50 TINTED15 g in 1 TUBESTICK151

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71585-106SUNSCREEN SPF-50 TINTED (ZINC OXIDE) STICK [SALT AND STONE]1Legacy NDC, 1 package rows20190525_7afc8a56-7ca0-4147-a19e-b7aa2b4b9377.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71585-10671585-106-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIM
SHEA BUTTERK49155WL9YIACT
YELLOW WAX2ZA36H0S2VIACT
COCONUT OILQ9L0O73W7LIACT
CARNAUBA WAXR12CBM0EIZIACT
SUNFLOWER OIL3W1JG795YIIACT
FERRIC OXIDE RED1K09F3G675IACT
MICAV8A1AW0880IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
JOJOBA OIL724GKU717MIACT
COCOA BUTTER512OYT1CRRIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
FERROUS OXIDEG7036X8B5HIACT

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
8a6ba2a7-715d-43ba-b483-40916cdda1337afc8a56-7ca0-4147-a19e-b7aa2b4b93772019-05-24WarningsExact identifier
spl id: 8a6ba2a7-715d-43ba-b483-40916cdda133
spl set id: 7afc8a56-7ca0-4147-a19e-b7aa2b4b9377

Reported adverse events (FAERS/openFDA)#

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