MACKENZIES OCEAN SAFE SUNSCREEN

Product NDC
80325-030
11-digit product format
803250030
Labeler code
80325
Product ID
80325-030_1fd0a790-c66d-216f-e063-6294a90ae971
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide
Dosage form
CREAM
Route
TOPICAL
Labeler
Naturally Uncommon, LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-07-01
Substance
TITANIUM DIOXIDE
Active strength
8.8 g/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
MACKENZIES OCEAN SAFE SUNSCREEN
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TITANIUM DIOXIDE8.8 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
15FIX9V2JPInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1fd0a790-c66c-216f-e063-6294a90ae971Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80325-030-03MACKENZIES OCEAN SAFE SUNSCREEN88 mL in 1 TUBECREAM881

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80325-030MACKENZIES OCEAN SAFE SUNSCREEN (TITANIUM DIOXIDE) CREAM [NATURALLY UNCOMMON, LLC]1Current NDC, 1 package rows20240817_1fd0a790-c66c-216f-e063-6294a90ae971.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 28 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ILIA SUPER SERUM SKIN TINT (ST10 PORTO FERRO)ZINC OXIDEIlia, Inc.b595a378-3285-bea2-e053-2995a90aedbf2026-05-21WarningsExact identifier
application number: M020
ILIA SUPER SERUM SKIN TINT (ST15 PORTO COVO)ZINC OXIDEIlia, Inc.b595db16-796c-726f-e053-2995a90ab7832026-05-21WarningsExact identifier
application number: M020
ILIA SUPER SERUM SKIN TINT (ST2 TULUM)ZINC OXIDEIlia, Inc.b5939cc9-4eab-5f73-e053-2995a90a7a7b2026-05-21WarningsExact identifier
application number: M020
ILIA SUPER SERUM SKIN TINT (ST8 SHELA)ZINC OXIDEIlia, Inc.b5956413-af6b-11bd-e053-2a95a90a90472026-05-21WarningsExact identifier
application number: M020
ILIA SUPER SERUM SKIN TINT (ST9 PALOMA)ZINC OXIDEIlia, Inc.b5959358-0d93-aa37-e053-2995a90acdae2026-05-21WarningsExact identifier
application number: M020
ILIA SUPER SERUM SKIN TINT (ST1 RENDEZVOUS)ZINC OXIDEIlia, Inc.b592225c-904e-350a-e053-2a95a90adc2b2026-05-21WarningsExact identifier
application number: M020
ILIA SUPER SERUM SKIN TINT (ST7 DIAZ)ZINC OXIDEIlia, Inc.b5954732-66d7-53db-e053-2995a90a2a3b2026-05-21WarningsExact identifier
application number: M020
ILIA SUPER SERUM SKIN TINT (ST4 FORMOSA)ZINC OXIDEIlia, Inc.b594d426-a79e-19e9-e053-2995a90aa6652026-05-21WarningsExact identifier
application number: M020
ILIA SUPER SERUM SKIN TINT (ST3 BALOS)ZINC OXIDEIlia, Inc.b594bc81-d164-bda7-e053-2995a90a69ad2026-05-21WarningsExact identifier
application number: M020
ILIA SUPER SERUM SKIN TINT (ST18 MALI)ZINC OXIDEIlia, Inc.b59608e6-a407-75dc-e053-2995a90a25cf2026-05-21WarningsExact identifier
application number: M020
ILIA SUPER SERUM SKIN TINT (ST19 LOVINA)ZINC OXIDEIlia, Inc.b9805c9c-0513-2386-e053-2995a90a21852026-05-21WarningsExact identifier
application number: M020
ILIA SUPER SERUM SKIN TINT (ST5 BOM BOM)ZINC OXIDEIlia, Inc.b594f910-f1bc-2bcf-e053-2995a90aebee2026-05-21WarningsExact identifier
application number: M020
ILIA SUPER SERUM SKIN TINT (ST17.5 PERISSA)ZINC OXIDEIlia, Inc.b9805059-583d-e3da-e053-2a95a90a4f652026-05-21WarningsExact identifier
application number: M020
ILIA SUPER SERUM SKIN TINT (ST14.5 HONOPU)ZINC OXIDEIlia, Inc.b9803596-c090-463f-e053-2a95a90a02342026-05-21WarningsExact identifier
application number: M020
ILIA SUPER SERUM SKIN TINT (ST6.5 KAI)ZINC OXIDEIlia, Inc.b97f5589-069d-7e93-e053-2a95a90a19a92026-05-21WarningsExact identifier
application number: M020
ILIA SUPER SERUM SKIN TINT (ST12.75 PAPAKOLEA)ZINC OXIDEIlia, Inc.b97fa903-4a0f-064e-e053-2a95a90a1c612026-05-21WarningsExact identifier
application number: M020
ILIA SUPER SERUM SKIN TINT (ST16.5 JARDIN)ZINC OXIDEIlia, Inc.b980155b-98f1-6460-e053-2a95a90a58a22026-05-21WarningsExact identifier
application number: M020
ILIA SUPER SERUM SKIN TINT (ST13.5 RIALTO)ZINC OXIDEIlia, Inc.b97fadb3-fa6e-26b0-e053-2a95a90abfd52026-05-21WarningsExact identifier
application number: M020
ILIA SUPER SERUM SKIN TINT (ST9.5 BAIKAL)ZINC OXIDEIlia, Inc.b97f7fe9-c06e-7c11-e053-2a95a90a6a6d2026-05-21WarningsExact identifier
application number: M020
ILIA SUPER SERUM SKIN TINT (ST12.5 RAMLA BAY)ZINC OXIDEIlia, Inc.b97f9d4d-6bdb-6823-e053-2995a90a51432026-05-21WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80325-030-038032500300388 mL in 1 TUBE (80325-030-03) 88 ml2022-07-01NoNoCurrent