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 284 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Safeway Signature Care Dry Touch Sunscreen SPF 55AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESafeway, Inc.c6267a29-46a5-5f38-e053-2a95a90a01172024-10-14WarningsExact identifier
application number: M020
Open Nature Zinc Oxide Sunscreen Mineral Sunscreen SPF 30ZINC OXIDESafeway, Inc.dbeff8e8-250d-8274-e053-2995a90a984e2024-10-14WarningsExact identifier
application number: M020
Positive Light Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 10NHOMOSALATE, ZINC OXIDERare Beauty, LLC2460281d-d433-0216-e063-6394a90a9d482024-10-13WarningsExact identifier
application number: M020
Walgreens 50 Coconut Scented Continuous SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANY2436987c-2afe-06b5-e063-6394a90aceba2024-10-11WarningsExact identifier
application number: M020
Walgreens 50 Banana Scented Continuous SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANY2436bd19-2299-6e89-e063-6394a90acd992024-10-11WarningsExact identifier
application number: M020
Walgreens SPF 50 Clear Complexion Face SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANYf07238df-4970-7759-e053-2a95a90a39f92024-10-11WarningsExact identifier
application number: M020
Walgreens SPF 70 Sport ContinuousAVOBENZONE, HOMOSALATE, OCTISALATE, OCTCRYLENEWALGREEN COMPANYe7165b39-54f9-4af6-e053-2a95a90af6642024-10-11WarningsExact identifier
application number: M020
WALGREENS SPF 100 SHEER BODY SUNSCREEN MISTAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANYf14bb3b4-1dce-06b9-e053-2995a90a8bc82024-10-11WarningsExact identifier
application number: M020
Walgreens SPF 30 SportAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANYf12c9767-7cb7-12c8-e053-2995a90a17be2024-10-11WarningsExact identifier
application number: M020
Sulwhasoo UV Daily CreamAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE CREAMAmorepacific Corporatione00451d5-8433-c4e8-e053-2a95a90a62442024-10-11WarningsExact identifier
application number: M020
Walgreens SPF 50 Sport Continuous SunscreenAVOBENZONE, HOMOSALAT, OCTISALATE, OCTOCRYLENEWALGREEN COMPANYf13ec3da-2dc2-04f7-e053-2995a90a198d2024-10-11WarningsExact identifier
application number: M020
Walgreens SPF 30 HydratingAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANYf4155692-16a7-11e8-e053-2995a90abd342024-10-11WarningsExact identifier
application number: M020
Walgreens Daily Facial Moisturizer with Broad Spectrum SPF 30 SunscreenAVOBENZONE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANYf906792b-083e-13e2-e053-6294a90ab4cf2024-10-11WarningsExact identifier
application number: M020
Walgreens Daytime Facial Moisturizer with Broad Spectrum SPF 30 SunscreenHOMOSALATE, OCTOCRYLENE, ZINC OXIDEWALGREEN COMPANYf9c81d88-8e28-fa53-e053-6394a90ac5c42024-10-11WarningsExact identifier
application number: M020
WALGREENS 100 SHEER BROAD SPECTRUM SPF 100AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANYfa18067a-310b-bdc3-e053-6394a90aee792024-10-11WarningsExact identifier
application number: M020
Walgreens 50 Mineral Zinc Oxide SunscreenZINC OXIDEWALGREEN COMPANY24223fbf-8ce9-ec5e-e063-6294a90a29da2024-10-10WarningsExact identifier
application number: M020
Walgreens 50 Mineral Zinc Oxide SunscreenZINC OXIDEWALGREEN COMPANY2422b327-ea83-f4c3-e063-6394a90a5c6e2024-10-10WarningsExact identifier
application number: M020
Walgreens 50 Watermelon Scented Continuous SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANY24256e54-ae34-91b2-e063-6394a90a33c02024-10-10WarningsExact identifier
application number: M020
Walgreens 50 Premium Face Moisturizing SunscreenAVOBENZONE. HOMOSALATE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANY24265a48-fd07-c78a-e063-6394a90ab67e2024-10-10WarningsExact identifier
application number: M020
Walgreens Broad Spectrum SPF 50 Body Oil SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANY2410df0a-db52-0769-e063-6394a90a52f32024-10-09WarningsExact 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