FDA.reportPublic FDA data

PROCEUTICALS PRIVATE LABEL by TiZO daily defense tinted mineral sunscreen

Product NDC
58892-258
11-digit product format
588920258
Labeler code
58892
Product ID
58892-258_1cc19337-cf55-af5d-e063-6394a90a1ceb
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide, Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
Fallien Cosmeceuticals, LTD
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-07-08
Substance
ZINC OXIDE; TITANIUM DIOXIDE
Active strength
30; 100 mg/g; 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
PROCEUTICALS PRIVATE LABEL by TiZO daily defense tinted mineral sunscreen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE30 mg/g
TITANIUM DIOXIDE100 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup
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
1cc19337-cf54-af5d-e063-6394a90a1cebAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58892-258-50PROCEUTICALS PRIVATE LABEL by TiZO daily defense tinted mineral sunscreen53 g in 1 BOTTLE, PUMPCREAM531

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58892-258PROCEUTICALS PRIVATE LABEL BY TIZO DAILY DEFENSE TINTED MINERAL SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS, LTD]1Current NDC, 1 package rows20240709_1cc19337-cf54-af5d-e063-6394a90a1ceb.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 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Topco Topcare Everyday Mineral Sunscreen Continuous SPF 30ZINC OXIDETOPCO ASSOCIATES LLCf71e019b-392a-f8eb-e053-6394a90a871e2024-10-15WarningsExact identifier
application number: M020
TOPCARE EVERYDAY SPORT SPF 70 SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONETOPCO ASSOCIATES LLCa5b06600-f2b0-6d9b-e053-2995a90a59f02024-10-15WarningsExact identifier
application number: M020
TopCare Everyday Ultra Protection Sun SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETOPCO ASSOCIATES LLCf41d4c46-7998-afe6-e053-2995a90ab3612024-10-15WarningsExact identifier
application number: M020
TOPCO TOPCARE EVERYDAY BABY PROTECTION SUN SPF 50OCTISALATE, ZINC OXIDETOPCO ASSOCIATES LLCf71c9060-3daf-e1be-e053-6294a90a4f912024-10-15WarningsExact identifier
application number: M020
MINERAL SUNSCREEN SPF 50ZINC OXIDE, TITANIUM DIOXIDETOPCO ASSOCIATES LLCbfe076fa-f21f-2c46-e053-2a95a90acee42024-10-15WarningsExact identifier
application number: M020
HEB SPF 50 Mineral Sunscreen StickZINC OXIDEH.E.B.f58f0199-bf22-2197-e053-2995a90ae64f2024-10-15WarningsExact identifier
application number: M020
HEB SPF 50 Kids Blue Mineral Sunscreen Stick Berry ScentedZINC OXIDEH.E.B.f58d328c-8b30-b4d4-e053-2a95a90adb592024-10-15WarningsExact identifier
application number: M020
HEB SPF 50 Kids Purple Mineral Sunscreen Stick Grape ScentedZINC OXIDEH.E.B.f58ed2f9-67c3-ce91-e053-2995a90a12292024-10-15WarningsExact identifier
application number: M020
HEB Shimmer Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEH.E.Bf5930029-4c96-2576-e053-2995a90a7bed2024-10-15WarningsExact identifier
application number: M020
HEB SPF 50 Birthday Cake SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEH.E.Bf5a3313e-4935-1ce3-e053-2a95a90a6ad12024-10-15WarningsExact identifier
application number: M020
HEB SPF 50 White Gardenia Continuous SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEH.E.Bf5b6caf2-ebff-79fb-e053-2995a90ac2f82024-10-15WarningsExact identifier
application number: M020
HEB SPF 50 For Men SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE,OCTOCRYLENEH.E.Bf59461e3-9521-6a7b-e053-2a95a90a73b82024-10-15WarningsExact identifier
application number: M020
HEB SPF 50 Pink Peony SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE,OCTOCRYLENEH.E.Bf5a2c266-6fc9-21ae-e053-2995a90aec0e2024-10-15WarningsExact identifier
application number: M020
HEB SPF 50 Pink Peony Continuous SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEH.E.Bf5b7172a-b8fc-0d11-e053-2a95a90a9f732024-10-15WarningsExact identifier
application number: M020
HEB SPF 50 Peach Bellini Scented Continuous SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEH.E.Bf5cbac04-361f-9226-e053-2995a90a2d7b2024-10-15WarningsExact identifier
application number: M020
HEB SPF 50 Cucumber Water Scented Continuous SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEH.E.Bf5d933cf-3461-8b03-e053-2a95a90ad79f2024-10-15WarningsExact identifier
application number: M020
HEB Oil Free Facial Moisturizer with Sunscreen Broad Spectrum SPF 15AVOBENZONE, OCTISALATE, OCTOCRYLENEH.E.Bf6ce4ea0-d92f-368c-e053-6294a90a2a812024-10-15WarningsExact identifier
application number: M020
HEB SPF 50 White Gardenia SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE,OCTOCRYLENEH.E.Bf5a2702c-5451-58a1-e053-2a95a90adb8e2024-10-15WarningsExact identifier
application number: M020
HEB SPF 50 Strawberry Daquiri Scented Continuous SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEH.E.Bf5cb5f9a-6691-37c3-e053-2a95a90a9af02024-10-15WarningsExact identifier
application number: M020
HEB SPF 50 Rosewater Scented Continuous SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEH.E.Bf5db7ec6-0e9b-7044-e053-2a95a90a1e482024-10-15WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
58892-258-505889202585053 g in 1 BOTTLE, PUMP (58892-258-50) 53 g2024-07-08NoNoCurrent