FDA.reportPublic FDA data

CoTZ Kids Mineral Sun Stick

Product NDC
58892-362
11-digit product format
588920362
Labeler code
58892
Product ID
58892-362_2f7225d0-ddfb-e19a-e063-6294a90a52a8
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
2025-03-03
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

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CoTZ Kids Mineral Sun StickTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD2f7225d0-ddfa-e19a-e063-6294a90a52a82025-03-03WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings: For external use only. Do not use on damaged or broken skin. Stop use and ask a doctor if rash occurs. When using this product, keep out of eyes. Rinse with water to remove. Keep out of the reach of children. If swallowed, get medical help or contact a poison control center right away.

Additional Listing Data#

Finished product
Yes
Brand name base
CoTZ Kids Mineral Sun Stick
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE40 mg/g
TITANIUM DIOXIDE55 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiSOI2LOH54Z, 15FIX9V2JP

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
58892-362-30CoTZ Kids Mineral Sun Stick30 g in 1 CYLINDERSTICK301
58892-362-30CoTZ Kids Mineral Sun Stick1 in 1 CARTONSTICK11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58892-362COTZ KIDS MINERAL SUN STICK (TITANIUM DIOXIDE, ZINC OXIDE) STICK [FALLIEN COSMECEUTICALS, LTD]1Current NDC, 2 package rows20250305_2f7225d0-ddfa-e19a-e063-6294a90a52a8.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
58892-362-30588920362301 CYLINDER in 1 CARTON (58892-362-30) / 30 g in 1 CYLINDER1 cylinder2025-03-03NoNoCurrent