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 15 of 361 · 7,213 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Aussie Betta Tallow Sunscreen SPF50 SPF50TITANIUM DIOXIDE AND ZINC OXIDE SUNSCREENAUSSIE BETTA HEALTHY CARE PTY LTD56007d82-ff5b-6c26-e063-6294a90a09b62026-07-07WarningsExact identifier
application number: M020
Bath and Body Works SPF Pink DreamAVOBENZONE,HOMOSALATE,OCTISALATEBath & Body Works, Inc.560785f5-9126-12ba-e063-6294a90ac9462026-07-07WarningsExact identifier
application number: M020
Bath and Body Works SPF Sunkissed BerryAVOBENZONE,HOMOSALATE,OCTISALATEBath & Body Works, Inc.56078698-8655-12bd-e063-6294a90ad34c2026-07-07WarningsExact identifier
application number: M020
Bath and Body Works SPF CoconutAVOBENZONE,HOMOSALATE,OCTISALATEBath & Body Works, Inc.56078491-f7d6-97f7-e063-6394a90a6deb2026-07-07WarningsExact identifier
application number: M020
Natu Botanicals DAILY NATURAL SUNSCREEN SPF 35 Reef safe mineral sunscreen with non-nano zinc oxideZINC OXIDESurprise Enterprise LLC38cf4325-9720-f511-e063-6394a90ad6282026-07-07WarningsExact identifier
application number: M020
Sun Bum Road Tripper - Amazon - Coconut Lip Balm SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC560c0f35-2132-52a6-e063-6394a90a2d242026-07-07WarningsExact identifier
application number: M020
Ciele lip and PROTECT lipstick SPF 60 BonnieCIELE LIP AND PROTECT LIPSTICK SPF 60 BONNIEDelicate Cosmetics Inc560d1d19-87a6-179b-e063-6294a90ada5e2026-07-07WarningsExact identifier
application number: M020
Ciele lip and PROTECT lipstick SPF 60 KellyCIELE LIP AND PROTECT LIPSTICK SPF 60 KELLYDelicate Cosmetics Inc560df34a-e6da-0792-e063-6394a90a7e712026-07-07WarningsExact identifier
application number: M020
Ciele lip and PROTECT lipstick SPF 60 LouLouCIELE LIP AND PROTECT LIPSTICK SPF 60 LOULOUDelicate Cosmetics Inc560e37ae-87c0-39d2-e063-6394a90a2af42026-07-07WarningsExact identifier
application number: M020
Ciele lip and PROTECT lipstick SPF 60 CassetteCIELE LIP AND PROTECT LIPSTICK SPF 60 CASSETTEDelicate Cosmetics Inc560e4198-b07c-3d48-e063-6394a90a7be32026-07-07WarningsExact identifier
application number: M020
Ciele lip and PROTECT lipstick SPF 60 MargauxCIELE LIP AND PROTECT LIPSTICK SPF 60 MARGAUXDelicate Cosmetics Inc560e47d5-c881-438c-e063-6394a90a30912026-07-07WarningsExact identifier
application number: M020
Ciele lip and PROTECT lipstick SPF 60 SaddleCIELE LIP AND PROTECT LIPSTICK SPF 60 SADDLEDelicate Cosmetics Inc560e5de5-1350-4046-e063-6394a90abffa2026-07-07WarningsExact identifier
application number: M020
Ciele lip and PROTECT lipstick SPF 60 PuzzleCIELE LIP AND PROTECT LIPSTICK SPF 60 PUZZLEDelicate Cosmetics Inc560e5558-8e46-7736-e063-6294a90acb052026-07-07WarningsExact identifier
application number: M020
EELHOE Body Coverage PerfectorTITANIUM DIOXIDEShantou Eelhoe Daily Chemical Technology Co., Ltd.5610c3b7-456b-3bc1-e063-6394a90a3fa82026-07-07WarningsExact identifier
application number: M020
Sunscreen SPF 50AVOBENZONE 3% HOMOSALATE 10% OCTOCRYLENE 5%Worthy Promotional Products1d4be26a-4695-491c-85d1-86824e1cd0292026-07-06WarningsExact identifier
application number: M020
SPF 30 SunscreenHOMOSALATE 10% OCTISALATE 5% AVOBENZONE 3%Coconut Caliente Costa Rica LLC71856cb3-9386-4569-80e4-92826342e3862026-07-06WarningsExact identifier
application number: M020
Stay Ageless SunscreenBROAD SPECTRUM SPF 30TOXFAIRY, LLC55f7e07e-1689-6d38-e063-6294a90a91192026-07-06WarningsExact identifier
application number: M020
Premier Tinted Mineral SunscreenBROAD SPECTRUM SPF30Emerald Aesthetics LLC55f88dd1-346c-22a5-e063-6294a90a711f2026-07-06WarningsExact identifier
application number: M020
RR SunHOMOSALATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONEUndefined Inc87244432-2967-4145-89cd-11a7567083a32026-07-06WarningsExact identifier
application number: M020
TOCOBO Cotton Airy Sun StickAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEPICTON CO., Ltd.35af90d3-dfe1-30dc-e063-6294a90a10a52026-07-05WarningsExact 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