FDA.reportPublic FDA data

TiZO Photoceutical AM Replenish - Tinted

Product NDC
58892-101
11-digit product format
588920101
Labeler code
58892
Product ID
58892-101_26bde5bd-1ffa-91f1-e063-6294a90adaf6
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
2015-10-13
Substance
ZINC OXIDE
Active strength
160 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 Photoceutical AM Replenish - Tinted
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE160 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
fbafa468-fce0-4597-bcb0-a816dc71ec7cAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58892-101-50TiZO Photoceutical AM Replenish - Tinted1 in 1 CARTONCREAM13
58892-101-50TiZO Photoceutical AM Replenish - Tinted50 g in 1 TUBECREAM503
58892-101-05TiZO Photoceutical AM Replenish - Tinted5 g in 1 TUBECREAM51
58892-101-15TiZO Photoceutical AM Replenish - Tinted1.5 g in 1 PACKETCREAM1.51
58892-101-30TIZO PHOTOCEUTICAL AM REPLENISH - TINTED30 g in 1 TUBECREAM301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58892-101TIZO PHOTOCEUTICAL AM REPLENISH - TINTED (ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS, LTD]3Current NDC, Legacy NDC, 2 package rows20241115_fbafa468-fce0-4597-bcb0-a816dc71ec7c.zip
58892-101TIZO PHOTOCEUTICAL AM REPLENISH - TINTED (ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS, LTD]1Current NDC, Legacy NDC, 1 package rows20250212_2cc73c4f-30ea-0a51-e063-6394a90ac9a4.zip
58892-101TIZO PHOTOCEUTICAL AM REPLENISH - TINTED (ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS, LTD]1Current NDC, Legacy NDC, 1 package rows20250212_2cc84aba-006b-a78e-e063-6294a90ae040.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 311 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LOreal Paris Youth Code Dark Spot Corrector Broad Spectrum SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEL'Oreal USA Products Inca32f7458-d7ad-47e5-804d-de260c0726de2023-12-29WarningsExact identifier
application number: M020
LOreal Paris Infallible Up to 24 H Fresh Wear Foundation Broad Spectrum SPF 25 SunscreenOCTINOXATE AND TITANIUM DIOXIDEL'Oreal USA Products Inc917f6775-8f48-4b7e-9f67-253bc0c6d59e2023-12-29WarningsExact identifier
application number: M020
LOreal Paris Revitalift Triple Power Broad Spectrum SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc9b6adfab-cafa-4343-9c96-e187fe0986db2023-12-29WarningsExact identifier
application number: M020
NUDESCREEN BLUSH TINT SPF 30 - STRAWBERRY SUNBURSTZINC OXIDE SUNSCREENBentley Laboratories, LLC4785585e-b623-4125-9867-8097694c7b582023-12-29WarningsExact identifier
application number: M020
LOreal Paris Visible lift Serum Absolute Advanced Age Reversing Makeup Broad Spectrum SPF 17OCTINOXATE AND TITANIUM DIOXIDEL'Oreal USA Products Inca31dacaa-738d-4da8-95b2-4d737c5266832023-12-29WarningsExact identifier
application number: M020
LOreal Paris Age Perfect Cell Renewal Day Moisturizer Broad Spectrum SPF 25 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc8e294a61-97e2-4df8-8a59-7cec12c6f0162023-12-29WarningsExact identifier
application number: M020
NUDESCREEN BLUSH TINT SPF 30- SUNSET ROSEZINC OXIDE SUNSCREENBentley Laboratories, LLCe351dff2-4237-4458-a947-b894e7b670a32023-12-29WarningsExact identifier
application number: M020
LOreal Paris Wrinkle Expert Age Defense 55 Plus Broad Spectrum SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEL'Oreal USA Products Incfa0b25a9-648a-4c7e-95c0-b7cb3dd525dd2023-12-29WarningsExact identifier
application number: M020
Radiant Shield Broad spectrum SPF 40 Tinted Mineral SunscreenZINC OXIDECosMedical Technologies, LLCef75cd9d-eaf5-430e-9a80-30c50da921ff2023-12-28WarningsExact identifier
application number: M020
SkinCeuticals Daily Brightening UV Defense Broad Spectrum SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc76e03a17-947a-492a-9e64-d3f7762de8232023-12-28WarningsExact identifier
application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios UV Hydra Daily Invisible Broad Spectrum SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inccc61299b-5088-4cef-b90e-f5de67e46b252023-12-28WarningsExact identifier
application number: M020
Maybelline New York Instant Age Rewind Eraser Treatment Makeup Broad Spectrum SPF 18 SunscreenOCTINOXATEL'Oreal USA Products Incea0609be-eaa9-4b63-9f07-e2cd974e01ba2023-12-28WarningsExact identifier
application number: M020
Maybelline New York Fit Dewy Plus Smooth Normal to Dry Broad Spectrum SPF 18 SunscreenOCTINOXATEL'Oreal USA Products Incb3a37055-b58f-4c42-963b-01c1136f692d2023-12-28WarningsExact identifier
application number: M020
Maybelline New York Fit Me Foundation Dewy Plus Smooth SPF 18 SunscreenOCTINOXATEL'Oreal USA Products Inc52e169b7-3560-489e-b7ab-1fea01466c0c2023-12-28WarningsExact identifier
application number: M020
Maybelline New York Fit Me Matte Plus Poreless Mattifying Poreless Primer Broad Spectrum SPF 20 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEL'Oreal USA Products Incc0c2aac2-1cd3-4e97-894c-a828fd9dba9b2023-12-28WarningsExact identifier
application number: M020
Maybelline New York Master Prime By Face Studio Primer Broad Spectrum SPF 30 SunscreenOCTINOXATELOreal USA Products Incfeabb713-4ef1-45b3-b34f-562e37b314d52023-12-28WarningsExact identifier
application number: M020
SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATETekweld Solutions, Inc.dc3f8339-23c1-4882-8682-685623027bdf2023-12-27WarningsExact identifier
application number: M020
Dermablend Professional Smooth Camo Medium Coverage Foundation Broad Spectrum SPF 25 SunscreenTITANIUM DIOXIDEL'Oreal USA Products Incaec1957a-f68d-4fbd-af9e-f8b257daea462023-12-27WarningsExact identifier
application number: M020
Vichy Laboratoires Capital Soleil 60 Daily AntiAging Face and Body Sunscreen Broad Spectrum SPF 60 Water Resistant 80 MinutesAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENELOreal USA Products Inc8404ef40-35fd-4460-a35f-d473b3c04c872023-12-27WarningsExact identifier
application number: M020
Dermablend Professional CC Continuous Correction Full Coverage Makeup Broad Spectrum SPF 50 Plus SunscreenHOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Incc4514240-f09b-48e3-94d6-d45dc426900e2023-12-27WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58892-101-05588920101055 g in 1 TUBE (58892-101-05) 5 g2019-07-23YesNoCurrent
58892-101-15588920101151.5 g in 1 PACKET (58892-101-15) 1.5 g2019-07-23YesNoCurrent
58892-101-305889201013030 g in 1 TUBE (58892-101-30) 30 g2015-10-13NoNoCurrent
58892-101-50588920101501 TUBE in 1 CARTON (58892-101-50) / 50 g in 1 TUBE1 tube2019-07-230000-00-00NoNoCurrent