FDA.reportPublic FDA data

CoTZ Mineral Suns Stick - Tinted SPF 45

Product NDC
58892-349
11-digit product format
588920349
Labeler code
58892
Product ID
58892-349_2fb0bd71-d774-4353-b919-743df1fdf3bd
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide, Zinc Oxide
Dosage form
STICK
Route
TOPICAL
Labeler
Fallien Cosmeceuticals, LTD
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-04-01
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
40; 55 mg/g; mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct58892-349UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage58892-34958892-349-01UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…

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
CoTZ Mineral Suns Stick - Tinted SPF 45
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TITANIUM DIOXIDE40 mg/g
ZINC OXIDE55 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
15FIX9V2JPInternal UNII lookup
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
44a6ff9b-8067-4f32-acb2-4ede54c79e6eAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58892-349-01CoTZ Mineral Suns Stick - Tinted SPF 451 in 1 CARTONSTICK12
58892-349-01CoTZ Mineral Suns Stick - Tinted SPF 4530 g in 1 CYLINDERSTICK302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58892-349COTZ MINERAL SUNS STICK - TINTED SPF 45 (TITANIUM DIOXIDE, ZINC OXIDE) STICK [FALLIEN COSMECEUTICALS, LTD]2Current NDC, Legacy NDC, 2 package rows20250112_44a6ff9b-8067-4f32-acb2-4ede54c79e6e.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 108 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
First Aid Beauty FAB Ultra Repair Face Moisturizer with Sunscreen Broad Spectrum SPF 30OCTOCRYLENE, AND ZINC OXIDEThe Procter & Gamble Manufacturing Companyf6801575-6081-7566-e053-2995a90a20a82025-12-18WarningsExact identifier
application number: M020
Olay Regenerist Regenerating with Sunscreen Broad Spectrum SPF 15AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEThe Procter & Gamble Manufacturing Company00280745-908b-468f-e063-6294a90aa12f2025-12-18WarningsExact identifier
application number: M020
OLAY Prime plus Protect Facial Sunscreen with Vitamin C SPF35 Matte FinishAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEThe Procter & Gamble Manufacturing Company10bd41ac-9b96-840d-e063-6394a90a98d92025-12-18WarningsExact identifier
application number: M020
Olay Glow plus Protect Sunscreen Dewy Glow SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONEThe Procter & Gamble Manufacturing Company10bc4127-7569-d0de-e063-6294a90a97bf2025-12-18WarningsExact identifier
application number: M020
First Aid Beauty FAB Hydrating Sunscreen Milk Broad Spectrum SPF 45AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEThe Procter & Gamble Manufacturing Company29645d90-a444-4090-e063-6294a90ac7e32025-12-18WarningsExact identifier
application number: M020
Skin On Skin BC Foundation SPF 40 - Tan GoldenOCTISALATE, HOMOSALATE, ZINC OXIDEYENSA Beauty, LLC46440bac-de69-e59c-e063-6394a90a76c02025-12-18WarningsExact identifier
application number: M020
FUSIDYNE DERMA TROUBLE Zinc Calming SunscreenZINC OXIDEDONG WHA PHARM. CO., LTD.46457c78-74d6-ea6a-e063-6294a90a24ac2025-12-18WarningsExact identifier
application number: M020
THE MUG GUARD Invisible Gel Suncare for FaceAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEDune Suncare, Inc.4646988c-1060-ed5f-e063-6394a90aa7652025-12-18WarningsExact identifier
application number: M020
Sage and Zinc Facial Hydrating SPF15ZINC OXIDEEmeis Cosmetics Pty Ltdccabd647-ecdd-7230-e053-2a95a90a7a962025-12-18WarningsExact identifier
application number: M020
Avail Facial Sunscreen SPF 25HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEEmeis Cosmetics Pty Ltd7be903e4-5f07-35b2-e053-2991aa0a13402025-12-17WarningsExact identifier
application number: M020
Mineral Sheer StickZINC OXIDESupergoop, LLC0beed72e-51df-d15a-e063-6394a90af5592025-12-17WarningsExact identifier
application number: M020
Sunscreen Lotion118mlZINC OXIDE 12%,TITANIUM DIOXIDE 6%, HOMOSALATE 14%,OCTISALATE 5%Foshan Sugar Max Cosmetics CO.,Ltd4620c41a-2188-00f5-e063-6394a90a613c2025-12-17WarningsExact identifier
application number: M020
Sunscreen CreamZINC OXIDE 15%,TITANIUM DIOXIDE 6%,HOMOSALATE 5%,OCTISALATE 4%Foshan Sugar Max Cosmetics CO.,Ltd46224dbe-a0fb-c242-e063-6394a90a26342025-12-17WarningsExact identifier
application number: M020
CAPTURE TOTALE C.E.L.L. ENERGY SUPER POTENT SERUM FOUNDATION BROAD SPECTRUM SPF 20 0NENSULIZOLE, OCTISALATEParfums Christian Dior31141a45-54e2-4463-ab42-4df56d9116502025-12-17WarningsExact identifier
application number: M020
Perricone High Potency Face Finishing and Firming MoisturizerTITANIUM DIOXIDE, ZINC OXIDETHG Beauty USA LLC2409cea1-7077-dc12-e063-6294a90a45582025-12-17WarningsExact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEGlow Advanced Skin and Body Care, LLC3635a073-5484-f96c-e063-6394a90adef52025-12-17Exact identifier
application number: M020
Mineral Sunscreen LipTITANIUM DIOXIDE, ZINC OXIDEGlow Advanced Skin and Body Care, LLC36362dc7-31d7-f766-e063-6294a90a129b2025-12-17Exact identifier
application number: M020
Mineral Sunscreen Non-TintedZINC OXIDEGlow Advanced Skin and Body Care, LLC3635e45b-6978-ac69-e063-6294a90a22ac2025-12-17Exact identifier
application number: M020
Prime and ProtectTITANIUM DIOXIDE, ZINC OXIDEShannon Cornelsen-Lewandowski36480f7f-37e8-decd-e063-6394a90ada602025-12-17Exact identifier
application number: M020
Prime and ProtectTITANIUM DIOXIDE, ZINC OXIDEShannon Cornelsen-Lewandowski364827bd-5781-eb53-e063-6394a90ab22f2025-12-17Exact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58892-349-01588920349011 CYLINDER in 1 CARTON (58892-349-01) / 30 g in 1 CYLINDER1 cylinder2022-04-010000-00-00NoNoCurrent