FDA.reportPublic FDA data

Zealios SPF LipGuard

Product NDC
83326-002
11-digit product format
833260002
Labeler code
83326
Product ID
83326-002_65123dc9-9354-4015-8507-d8d4e6bc2e01
Type
HUMAN OTC DRUG
Nonproprietary name
OCTISALATE and AVOBENZONE
Dosage form
GEL
Route
TOPICAL
Labeler
Personal Best Products Inc. dba Zealios
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-06-21
Substance
OCTISALATE; AVOBENZONE
Active strength
50; 30 mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct83326-002UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage83326-00283326-002-01UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Zealios SPF LipGuard
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTISALATE50 mg/mL
AVOBENZONE30 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4X49Y0596WInternal UNII lookup
G63QQF2NOXInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3a07822b-a7c9-40af-a8f7-bea591c7a49bAvailable on FDA.report

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

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 180 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
toty Ilumina CC Creamy Compact Refill 1CTITANIUM DIOXIDEChipican LLCf0596830-77ed-11f0-e053-2995a90a8ff52025-09-29WarningsExact identifier
application number: M020
U V-Lamp Shield Mani-SunscreenZINC OXIDE, TITANIUM DIOXIDEGUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD3fe7e1c3-e6cd-1420-e063-6394a90a41382025-09-28WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC053e76f0-8ca0-645d-e063-6394a90a01d22025-09-28WarningsExact identifier
application number: M020
Hawaiian Tropic Mineral Translucent Sunscreen Powder SPF 30ZINC OXIDEEdgewell Personal Care Brands LLCcdc54f23-0efb-2fb4-e053-2995a90ae58b2025-09-28WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC0540017a-52ac-7972-e063-6394a90a139c2025-09-28WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC08f3b27f-b233-d406-e063-6394a90ada762025-09-28WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC128a3772-b9b7-0d10-e063-6294a90a3e052025-09-28WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC203c82a2-0131-8023-e063-6294a90aba7b2025-09-28WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC203c780a-3107-d71a-e063-6394a90aca252025-09-28WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC31d01fae-4085-d84a-e063-6294a90ab9812025-09-28WarningsExact identifier
application number: M020
Hawaiian TropicAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands, LLC3388c2fa-8082-95d4-e063-6294a90a94b82025-09-28WarningsExact identifier
application number: M020
Neutrogena Beach Defense Water Plus Sun Protection Sunscreen Broad Spectrum SPF30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONEKenvue Brands LLCb10a7794-7e4f-412b-9eb2-773107ecb7fc2025-09-26WarningsExact identifier
application number: M020
Black Girl Sunscreen SPF 50HOMOSALATE 10.00% OCTOCRYLENE 10.00% OCTISALATE 5.00% AVOBENZONE 3.00%Black Girl Sunscreenfed22570-e0ae-43e1-b6ce-1f0ad01684c32025-09-26WarningsExact identifier
application number: M020
Smooth Even GlowTINTED SUNSCREEN BROAD SPF30SKNVcare, LLC3fa48151-fcb9-3d35-e063-6394a90a2eb62025-09-25WarningsExact identifier
application number: M020
CHEEK CREME BROAD SPECTRUM SPF 30 SUNSCREEN BLUSH HEAT WAVEAVOBENZONE, HOMOSALATE, OCTISALATEMDSolarSciences3fa810b0-0211-f2a7-e063-6294a90a0b722025-09-25WarningsExact identifier
application number: M020
SUN BUFF SPF 30 MINERAL SUNSCREENZINC OXIDE/TITANIUM DIOXIDESPF Ventures, LLC3f874062-ebab-8993-e063-6294a90abfc52025-09-24WarningsExact identifier
application number: M020
HygieneLab Face and Body Mineral Sunscreen SPF 50ZINC OXIDEHYGIENELAB, INC7db103da-b434-433a-a18f-a727165640c02025-09-24WarningsExact identifier
application number: M020
Eve Lom Daily Protection Broad Spectrum SPF 50 SunscreenHOMOSALATE, OCTISALATE, OXYBENZONE, AVOBENZONE, OCTINOXATE AND OCTOCRYLENESpace Brands Limited0e2c9ffb-036d-49c5-abdb-2ee8888df3182025-09-24WarningsExact identifier
application number: M020
PUR 4-in-1 Skin Tint DG6ZINC OXIDEPUR Minerals3f8e97a7-2023-ba9c-e063-6294a90ac9c92025-09-24WarningsExact identifier
application number: M020
PUR 4-in-1 Skin Tint TN7ZINC OXIDEPUR Minerals3f0717c7-f43f-e3b1-e063-6394a90a74dd2025-09-24WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83326-002-01833260002017.39 mL in 1 TUBE, WITH APPLICATOR (83326-002-01) 7.39 ml2021-06-21NoNoCurrent