FDA.reportPublic FDA data

Spit & Polish Sun Smart Sunscreen Lotion SPF 50

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 Sun Smart Sunscreen
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure7 sections

Indications and uses

Helps prevent sunburn. If used as directed with other sun protection measures decreases the risk of skin cancer and early aging caused by the sun.

Dosage and administration

Apply liberally and evenly 15 minutes prior to sun exposure. Reapply after 80 minutes of swimming or sweating Reapply after towel drying. Reapply at least every 2 hours. 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 including limiting time in the sun. espec...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 7% and Zinc Oxide 10%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses:

INDICATIONS & USAGE SECTION

Helps prevent sunburn. If used as directed with other sun protection measures decreases the risk of skin cancer and early aging caused by the sun.

Warning:

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin.

When using this product

OTC - WHEN USING SECTION

avoid contact with eyes, contact with eyes occurs, flush with water to remove.

Stop use and ask a doctor

OTC - STOP USE SECTION

If irritation or rash develops or persists.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, seek immediate medical attention of contact a Poison Control Center right away.

Directions:

DOSAGE & ADMINISTRATION SECTION

Apply liberally and evenly 15 minutes prior to sun exposure. Reapply after 80 minutes of swimming or sweating Reapply after towel drying. Reapply at least every 2 hours.

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 including limiting time in the sun. especially between 10 a.m. and 2 pm, and wear long-sleeved shirts, pants, hats and sunglasses. Sun protection measures:

: Consult a physician. For use on children under 6

Other information:

SPL UNCLASSIFIED SECTION

Protect this product from excessive heat or direct sun.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

ALOE BARBADENSIS LEAF GEL,BUTYLOCTYL SALICYLATE, CAPRYLIC/ CAPRIC/ MYRISTIC/STEARIC TRIGLYCERIDES, CAPRYLIC/CAPRIC/TRIGLYCERIDE (AND) STEARALKONIUM HECTORITE (AND) PROPYLENE CARBONATE, CERA ALBA, DAUCUS CAROTA SATIVA (CARROT) EXTRACT, GLYCERIN (AND) CAMELLIA SINENSIS LEAF EXTRACT, HYDROGENATED COCO-GLYCERIDES, GLYCRRHIZA GLABRA (LICORICE) ROOT EXTRACT, LEUCONO STOC/RADISH ROOT FERMENT FILTRATE, MAGNESIUM SULFATE. POLYGLYCERYL 3 POLYRICINOLEATE, POLY- HYDROXYSTEARIC ACID, SORBITAN OLEATE, WATER.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label2Label2LabelLabel

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
80325-001-01Spit and Polish Sun Smart Sunscreen177 mL in 1 TUBELOTION1772

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80325-001SPIT AND POLISH SUN SMART SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [NATURALLY UNCOMMON, LLC]2Current NDC, Legacy NDC, 1 package rows20231110_af879a05-1483-5c11-e053-2995a90af45d.zip

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80325-00180325-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
GLYCERYL TRISTEARATEP6OCJ2551RIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
STEARALKONIUM HECTORITEOLX698AH5PIACT
PROPYLENE CARBONATE8D08K3S51EIACT
WHITE WAX7G1J5DA97FIACT
CARROTL56Z1JK48BIACT
GLYCERINPDC6A3C0OXIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
HYDROGENATED COCO-GLYCERIDESXDD37N2GPRIACT
GLYCYRRHIZA GLABRA2788Z9758HIACT
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATED2QHA03458IACT
MAGNESIUM SULFATE, UNSPECIFIED FORMDE08037SABIACT
SORBITAN MONOOLEATE06XEA2VD56IACT
WATER059QF0KO0RIACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
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 Sun Smart SunscreenTITANIUM DIOXIDE, ZINC OXIDENaturally Uncommon, LLCaf879a05-1483-5c11-e053-2995a90af45d2023-11-09WarningsExact identifier
ndc (package): 80325-001-01
ndc (product): 80325-001
ndc11 (package): 80325000101
spl id: 09c2d4fa-e9fb-318b-e063-6394a90a6d51
spl set id: af879a05-1483-5c11-e053-2995a90af45d

Reported adverse events (FAERS/openFDA)#

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