FDA.reportPublic FDA data

ALL NATURAL LIP BALM

Manufacturer
SALT AND STONE
Effective date
2019-04-11
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-05-31 22:59:10

Label at a glance#

ProductALL NATURAL LIP BALM SPF-30
Active ingredientZINC OXIDE
Label structure9 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. REAPPLY AT LEAST EVERY 2 HOURS. REAPPLY AFTER 80 MINUTES OF SWIMMING OR SWEATING. REAPPLY IMMEDIATELY AFTER TOWEL DRYING. SUN PROTECTIONS 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 8%

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.

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 PROTECTIONS 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

ARGANIA SPINOSA (ARGAN) KERNEL OIL, BEESWAX (CERA ALBA), BEHENYL BEHENATE, BISABOLOL, BUTYROSPERMUM PARKII (SHEA BUTTER), EUPHORBIA CERIFERA (CANDELILLA) WAX, CAPRYLIC/CAPRIC TRIGLYCERIDES, COCOS NUCIFERA (COCONUT) OIL, COPERNICIA CERIFERA (CARNAUBA) WAX, GLYCERYL CAPRYLATE, GLYCERYL UNDECYLENATE, HYDROGENATED METHYL ABIETATE, ISOSTEARIC ACID, LECITHIN, POLYHYDROXYSTEARIC ACID, POLYGLYCERYL-3 POLYRICINOLEATE, RICINUS COMMUNIS (CASTOR) SEED OIL, STEAIA REBAUDIANA, TOCOPHERYL ACETATE, VEGETABLE OIL.

OTHER INFORMATION

OTHER SAFETY INFORMATION

  • PROTECT THIS PRODUCT FROM EXCESSIVE HEAT AND DIRECT SUN

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

01b LBL_S-S_Lip Balm SPF-30_US01b LBL_S-S_Lip Balm 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
71585-103-212021-01-29C16284748780-1ba0f9c33-1bda-a910-e053-dadaa90a0b85SALT & STONE - ALL NATURAL LIP BALM SPF-30

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71585-103-21ALL NATURAL LIP BALMSPF-304.25 g in 1 TUBELOTION4.256

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71585-103ALL NATURAL LIP BALM SPF-30 (ZINC OXIDE) LOTION [SALT AND STONE]6Legacy NDC, 1 package rows20190412_39c9c1c3-fde9-42a5-8f76-43af06b6be30.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
71585-10371585-103-21

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIM
ARGAN OIL4V59G5UW9XIACT
YELLOW WAX2ZA36H0S2VIACT
BEHENYL BEHENATEK8NU647RJ0IACT
LEVOMENOL24WE03BX2TIACT
SHEA BUTTERK49155WL9YIACT
CANDELILLA WAXWL0328HX19IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
COCONUT OILQ9L0O73W7LIACT
CARNAUBA WAXR12CBM0EIZIACT
GLYCERYL CAPRYLATETM2TZD4G4AIACT
GLYCERYL 1-UNDECYLENATEB68LJT9544IACT
HYDROGENATED METHYL ABIETATEA23O709X8OIACT
ISOSTEARIC ACIDX33R8U0062IACT
LECITHIN, SOYBEAN1DI56QDM62IACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
POLYGLYCERYL-3 RICINOLEATEMZQ63P0N0WIACT
CASTOR OILD5340Y2I9GIACT
STEVIA LEAF6TC6NN0876IACT
CORN OIL8470G57WFMIACT

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
4e6ec930-814c-456a-b6fe-ea692cd486c939c9c1c3-fde9-42a5-8f76-43af06b6be302019-04-11WarningsExact identifier
spl id: 4e6ec930-814c-456a-b6fe-ea692cd486c9
spl set id: 39c9c1c3-fde9-42a5-8f76-43af06b6be30

Reported adverse events (FAERS/openFDA)#

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