FDA.reportPublic FDA data

TiZO Ultra Zinc SPF 40 (Tinted)

Product NDC
58892-319
11-digit product format
588920319
Labeler code
58892
Product ID
58892-319_25a288aa-1828-492a-e063-6294a90ae5c3
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
Fallien Cosmeceuticals, LTD
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-01-15
Substance
ZINC OXIDE
Active strength
200 mg/g
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
TiZO Ultra Zinc SPF 40 (Tinted)
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE200 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
36efd48b-910e-4b61-9519-a6d5c7e9a7c3Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58892-319-01TiZO Ultra Zinc SPF 40 (Tinted)100 g in 1 TUBECREAM1004
58892-319-01TiZO Ultra Zinc SPF 40 (Tinted)1 in 1 CARTONCREAM14
58892-319-05TiZO Ultra Zinc SPF 40 (Tinted)5 g in 1 TUBECREAM51
58892-319-15TiZO Ultra Zinc SPF 40 (Tinted)1.5 g in 1 PACKETCREAM1.51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58892-319TIZO ULTRA ZINC SPF 40 (TINTED) (ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS, LTD]4Current NDC, Legacy NDC, 2 package rows20241031_36efd48b-910e-4b61-9519-a6d5c7e9a7c3.zip
58892-319TIZO ULTRA ZINC SPF 40 (TINTED) (ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS, LTD.]1Current NDC, Legacy NDC, 1 package rows20250212_2d3faa43-0d78-58de-e063-6294a90a0b17.zip
58892-319TIZO ULTRA ZINC SPF 40 (TINTED) (ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS, LTD]1Current NDC, Legacy NDC, 1 package rows20250212_2d0856cf-d3da-5a77-e063-6294a90ad5b4.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 249 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06c62206-d838-8d9a-e063-6394a90a4c692024-12-26WarningsExact identifier
application number: M020
Ulta Beauty Tinted Moisturizer Cream Spf 24 LightAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECosmax Usa, Corporationfbbff4eb-a63e-b083-e053-6294a90a404a2024-12-26WarningsExact identifier
application number: M020
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06c6035e-c179-b3e6-e063-6394a90a86cd2024-12-26WarningsExact identifier
application number: M020
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06c618ae-3d4d-8c87-e063-6394a90a53962024-12-26WarningsExact identifier
application number: M020
KOPARI Sun Shield Soft Glow Daily Face SPF30OCTISALATE, OCTOCRYLENE, AVOBENZONE, HOMOSALATECOSMAX USA, CORPORATION0d436d06-3f81-b4a6-e063-6294a90aa6352024-12-26WarningsExact identifier
application number: M020
NEORA Invisibloc Sunscreen Gel Broad Spectrum SPF40AVOBENZONE, HOMOSALATE, OCTISALATECOSMAX USA, CORPORATION0d584736-3f55-2542-e063-6294a90af3cf2024-12-26WarningsExact identifier
application number: M020
NARS Radiance Primer Broad Spectrum SPF 35 SunscreenOCTISALATE, OCTOCRYLENE, AVOBENZONE, HOMOSALATECOSMAX USA, CORPORATION0d59d9cb-c891-1097-e063-6394a90a806e2024-12-26WarningsExact identifier
application number: M020
KOPARI Sun Shield Soft Glow Daily Face SPF30OCTISALATE, OCTOCRYLENE, AVOBENZONE, HOMOSALATECOSMAX USA, CORPORATION0d3673da-822b-09e2-e063-6394a90a348e2024-12-26WarningsExact identifier
application number: M020
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06c61c42-eddb-1ebd-e063-6294a90aee132024-12-26WarningsExact identifier
application number: M020
GLOSSIER INVISIBLE SHIELD DAILY SUNSCREEN BROAD SPECTRUM SPF 35AVOBENZONE, HOMOSALATE, OCTISALATECOSMAX USA, CORPORATION0d438692-cd83-ea42-e063-6394a90a862d2024-12-26WarningsExact identifier
application number: M020
KOPARI Antioxidant Face Shield Mineral SPF 30ZINC OXIDECOSMAX USA, CORPORATION0d43e22c-5e3d-df90-e063-6294a90aac2b2024-12-26WarningsExact identifier
application number: M020
NORWEX Protect Prevent Mineral Facial Sunscreen Broad Spectrum SPF30TITANIUM DIOXIDE, ZINC OXIDECOSMAX USA, CORPORATION0d489154-6168-977e-e063-6394a90aa6092024-12-26WarningsExact identifier
application number: M020
Ulta Beauty Tinted Moisturizer Cream Spf 24 FairAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECosmax Usa, Corporationfbbfa61a-cbb4-3104-e053-6394a90a832f2024-12-26WarningsExact identifier
application number: M020
Ulta Beauty Tinted Moisturizer Cream Spf 24 Tan to darkAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECosmax Usa, Corporatione6c4b8eb-5aa3-49c2-af9e-eaf5fafb029c2024-12-26WarningsExact identifier
application number: M020
Ulta Beauty Tinted Moisturizer Cream Spf 24 Light to MediumAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECosmax Usa, Corporationfbc05ceb-2e6b-3c37-e053-6394a90ac4f42024-12-26WarningsExact identifier
application number: M020
Ulta Beauty Tinted Moisturizer Cream Spf 24 MediumAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECosmax Usa, Corporationfbc0ff10-fb2f-e637-e053-6294a90a0c292024-12-26WarningsExact identifier
application number: M020
Ulta Beauty Tinted Moisturizer Cream Spf 24 DeepAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECosmax Usa, Corporation2984c64f-eaac-ecb6-e063-6394a90aeb122024-12-26WarningsExact identifier
application number: M020
Ulta Beauty Tinted Moisturizer Cream Spf 24 TanAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECosmax Usa, Corporation2984a014-a56f-753b-e063-6294a90a13f52024-12-26WarningsExact identifier
application number: M020
Julep No Excuses Gel for Face SPF40AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECosmax Usa, Corporation298404c4-d4be-7395-e063-6294a90a86bf2024-12-26WarningsExact identifier
application number: M020
Cover FX Invisible Primer SPF30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECosmax Usa, Corporation2983dd7c-7ca7-e952-e063-6394a90a30982024-12-26WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58892-319-01588920319011 TUBE in 1 CARTON (58892-319-01) / 100 g in 1 TUBE1 tube2022-03-150000-00-00NoNoCurrent
58892-319-05588920319055 g in 1 TUBE (58892-319-05) 5 g2022-03-15YesNoCurrent
58892-319-15588920319151.5 g in 1 PACKET (58892-319-15) 1.5 g2022-03-15YesNoCurrent