FDA.reportPublic FDA data

Mineral Lip Balm

Manufacturer
TUBBY TODD
Effective date
2024-12-18
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 00:44:38

Label at a glance#

ProductMineral Lip Balm SPF-15
Active ingredientZINC OXIDE
Label structure8 sections

Indications and uses

Helps protect against sunburn and chapped lips.

Dosage and administration

Apply liberally and as needed.

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 10.5%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

Helps protect against sunburn and chapped lips.

Warnings

WARNINGS SECTION

Stop use and ask a doctor if rash occurs

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If amount greater than normal use is swallowed get medical attention or call Poison Control Center immediately.

• Stop use and ask a doctor

OTC - STOP USE SECTION

if rash occurs

• Stop use and ask a doctor

OTC - STOP USE SECTION

if rash occurs

Directions

INSTRUCTIONS FOR USE SECTION

Apply liberally and as needed.

Other information

OTHER SAFETY INFORMATION

Protect this product from excessive heat and direct sun.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Helianthus Annuus (Sunflower) Seed Oil*, Beeswax*, Caprylic/Capric Triglyceride, Cocos Nucifera (Coconut) Oil*, Natural Flavor*, Polyhydroxystearic Acid, Butyrospermum Parkii (Shea) Butter*, Rubus Idaeus (Raspberry) Seed Oil, Theobroma Cacao (Cocoa) Butter*, Tocopherol, Simmondsia Chinensis (Jojoba) Seed Oil*, Calophyllum Inophyllum (Tamanu) Seed Oil*
*Certified organic ingredient(s)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

01b LBL_Lip Balm_SPF15_Key Lime01b LBL_Lip Balm_SPF15_Key Lime

01b LBL_Mineral Lip Balm SPF-15_Pina Colada01b LBL_Mineral Lip Balm SPF-15_Pina Colada

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73088-105-11Mineral Lip BalmSPF-154.2 g in 1 TUBELIPSTICK4.29

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73088-105MINERAL LIP BALM SPF-15 (ZINC OXIDE) LIPSTICK [TUBBY TODD]9Current NDC, Legacy NDC, 1 package rows20241220_4d938672-5302-4e47-a582-c3e6467008cb.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73088-10573088-105-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
SUNFLOWER OIL3W1JG795YIIACT
YELLOW WAX2ZA36H0S2VIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
COCONUT OILQ9L0O73W7LIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
SHEA BUTTERK49155WL9YIACT
RUBUS IDAEUS SEEDM3CL7US2ZGIACT
TOCOPHEROLR0ZB2556P8IACT
COCOA BUTTER512OYT1CRRIACT
JOJOBA OIL724GKU717MIACT
TAMANU OILJT3LVK84A1IACT
ZINC OXIDESOI2LOH54ZACTIM

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
Mineral Lip Balm SPF-15ZINC OXIDETUBBY TODD4d938672-5302-4e47-a582-c3e6467008cb2024-12-18WarningsExact identifier
ndc (package): 73088-105-11
ndc (product): 73088-105
ndc11 (package): 73088010511
spl id: 29921ec7-3ef5-c018-e063-6294a90af3ef
spl set id: 4d938672-5302-4e47-a582-c3e6467008cb

Reported adverse events (FAERS/openFDA)#

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