FDA.reportPublic FDA data

Zealios SPF LipGuard

Manufacturer
Personal Best Products Inc. dba Zealios | Sun Deep Cosmetics
Effective date
2025-01-13
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:53:02

Label at a glance#

ProductZealios SPF LipGuard
Active ingredientOCTISALATE, AVOBENZONE
Label structure7 sections

Indications and uses

Helps prevent sunburn and chapped lips.

Dosage and administration

Apply liberally 15 minutes before sun exposure and reapply every 2 hours or as necessary. Children under 6 months of age: Ask a doctor before use.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active Ingredients:Purpose:
Octyl Salicylate 5%Sunscreen
Avobenzone 3%Sunscreen

Uses

INDICATIONS & USAGE SECTION

Helps prevent sunburn and chapped lips.

Warnings

WARNINGS SECTION

For external use only. Stop use if skin rash occurs. When using keep out of eyes.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. Protect this product from excessive heat.

Directions

DOSAGE & ADMINISTRATION SECTION

Apply liberally 15 minutes before sun exposure and reapply every 2 hours or as necessary. Children under 6 months of age: Ask a doctor before use.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Caprylic/Capric Triglyceride, Petrolatum, Beeswax, Butyloctyl Salicylate, Butyrospermum Parkii (Shea Butter) Fruit, Cocos Nucifera (Coconut Oil), Tocopheryl Acetate (Vitamin E), Simmondsia, Chinensis (Jojoba) Seed Oil.

PRINCIPAL DISPLAY PANEL - 7.39 ml Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

zealios

SPORT PERFORMANCE
LIPGUARD

Natural

Ultra Lip Protection
& Hydration

SPF
28

Broad Spectrum
SPF 28 Sunscreen
Clear & Long-Lasting

0.25 fl oz (7.39 ml)

PRINCIPAL DISPLAY PANEL - 7.39 ml Tube Label
PRINCIPAL DISPLAY PANEL - 7.39 ml Tube Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83326-002-01Zealios SPF LipGuard7.39 mL in 1 TUBE, WITH APPLICATORGEL7.392

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83326-002ZEALIOS SPF LIPGUARD (OCTISALATE AND AVOBENZONE) GEL [PERSONAL BEST PRODUCTS INC. DBA ZEALIOS]2Current NDC, 1 package rows20250119_3a07822b-a7c9-40af-a8f7-bea591c7a49b.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83326-00283326-002-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
OCTISALATE4X49Y0596WACTIB
AVOBENZONEG63QQF2NOXACTIB
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
PETROLATUM4T6H12BN9UIACT
YELLOW WAX2ZA36H0S2VIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
SHEA BUTTERK49155WL9YIACT
COCONUT OILQ9L0O73W7LIACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
JOJOBA OIL724GKU717MIACT

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
Zealios SPF LipGuardOCTISALATE AND AVOBENZONEPersonal Best Products Inc. dba Zealios3a07822b-a7c9-40af-a8f7-bea591c7a49b2025-01-13WarningsExact identifier
ndc (package): 83326-002-01
ndc (product): 83326-002
ndc11 (package): 83326000201
spl id: 65123dc9-9354-4015-8507-d8d4e6bc2e01
spl set id: 3a07822b-a7c9-40af-a8f7-bea591c7a49b

Reported adverse events (FAERS/openFDA)#

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