FDA.reportPublic FDA data

Spit and Polish Mineral Lip Balm Broad Spectrum Lip Protectant SPF 30

Manufacturer
Naturally Uncommon, LLC
Effective date
2023-11-09
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:59:44

Label at a glance#

ProductSpit and Polish Mineral Lip Balm Broad Spectrum Lip Protectant SPF 30
Active ingredientZINC OXIDE
Label structure5 sections

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 the risk, regularly use a sunscreen with a Broad Spectrum SPF of 15 or higher and other sun protection measures.

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. 
  • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings:

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

  • on damaged or broken skin.
  • If rash occurs,

stop use and consult a doctor.

OTC - STOP USE SECTION

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • 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 the risk, regularly use a sunscreen with a Broad Spectrum SPF of 15 or higher and other sun protection measures.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Prunus Amygdalus Dulcis (Almond) Oil, Butyrospermum Parkii (Shea) Butter, Cera Alba (Beeswax), Simmondsia Chinensis (Jojoba) Seed Oil, Euphorbia Cerifera (Candelilla) Wax, DL-Alpha-Tocopheryl Acetate, Argania Spinosa Kernel (Argan) Oil, Copernicia Cerifera (Carnauba) Wax, Bisabolol, Glyceryl Caprylate, Glyceryl Undecylenate, Triethoxycaprylylsilane

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle4Bottle4

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
80325-002-01Spit and Polish Mineral Lip Balm Broad Spectrum Lip Protectant SPF 304.25 g in 1 APPLICATORSTICK4.252

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80325-002SPIT AND POLISH MINERAL LIP BALM BROAD SPECTRUM LIP PROTECTANT SPF 30 (ZINC OXIDE) STICK [NATURALLY UNCOMMON, LLC]2Current NDC, Legacy NDC, 1 package rows20231110_af882b7e-c64f-0de6-e053-2995a90a7ca0.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
80325-00280325-002-01

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
ALMOND3Z252A2K9GIACT
SHEA BUTTERK49155WL9YIACT
YELLOW WAX2ZA36H0S2VIACT
JOJOBA OIL724GKU717MIACT
CANDELILLA WAXWL0328HX19IACT
.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8IACT
ARGAN OIL4V59G5UW9XIACT
CARNAUBA WAXR12CBM0EIZIACT
LEVOMENOL24WE03BX2TIACT
GLYCERYL MONOCAPRYLATETM2TZD4G4AIACT
GLYCERYL 1-UNDECYLENATEB68LJT9544IACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
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
Spit and Polish Mineral Lip Balm Broad Spectrum Lip Protectant SPF 30ZINC OXIDENaturally Uncommon, LLCaf882b7e-c64f-0de6-e053-2995a90a7ca02023-11-09WarningsExact identifier
ndc (package): 80325-002-01
ndc (product): 80325-002
ndc11 (package): 80325000201
spl id: 09c2dbb9-bc6a-b54b-e063-6294a90a9c25
spl set id: af882b7e-c64f-0de6-e053-2995a90a7ca0

Reported adverse events (FAERS/openFDA)#

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