FDA.reportPublic FDA data

CoTZ Kids Mineral Sun Stick

Manufacturer
Fallien Cosmeceuticals, LTD | Fragrance Manufacturing Inc. | Custom Analytics LLC
Effective date
2025-03-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:56:32

Label at a glance#

ProductCoTZ Kids Mineral Sun Stick
Active ingredientZINC OXIDE, TITANIUM DIOXIDE
Label structure9 sections

Indications and uses

Helps prevent sunburn. If used as directed with other sun protection measures (see directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Dosage and administration

Apply liberally 15 minutes before sun exposure. Reapply: After 80 minutes of swimming or sweating - immediately after towel drying - At least every 2 hours - Children under 6 months: Ask a doctor.

Label contents#

Full prescribing information#

Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 4% Zinc Oxide 5.5%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses:

INDICATIONS & USAGE SECTION

Helps prevent sunburn. If used as directed with other sun protection measures (see directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings:

WARNINGS SECTION

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.

Directions:

DOSAGE & ADMINISTRATION SECTION

Apply liberally 15 minutes before sun exposure. Reapply: After 80 minutes of swimming or sweating - immediately after towel drying - At least every 2 hours - Children under 6 months: Ask a doctor.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Alumina, Aluminum Hydroxide, Aluminum Stearate, Ascorbic Acid, Ascorbyl Palmitate, C12-15 Alkyl Benzoate, Cetearyl Isononanoate, Cetyl PEG/PPG-15/15 Butyl Ether Dimethicone, Citric Acid, Ethylene Brassylate, Ethylhexyl Palmitate, Helianthus Annuus (Sunflower) Wax, Hexyldecanol, Hexyldecyl Laurate, Lecithin, Ozokerite, PEG-8, Polyglyceryl-3 Diisostearate, Polyhydroxystearic Acid, Propylene Glycol Dicaprylate/Dicaprate, Stearic Acid, Tocopherol, Tocopheryl Acetate, Zingiber Officinale (Ginger) Root Oil

Other Information:

OTHER SAFETY INFORMATION

Protect this product from excessive heat and direct sun.

Warning:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package LabelPackage Label

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

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58892-36258892-362-30

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
HEXYLDECANOL151Z7P1317IACT
PEG-8B697894SGQIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
STEARIC ACID4ELV7Z65APIACT
TOCOPHEROLR0ZB2556P8IACT
HEXYLDECYL LAURATE0V595C1P6MIACT
PROPYLENE GLYCOL DICAPRYLATE/DICAPRATEO4446S9CRAIACT
PEG/PPG-15/15 DIMETHICONE184IZ28A2GIACT
ETHYLHEXYL PALMITATE2865993309IACT
POLYGLYCERYL-3 DIISOSTEARATE46P231IQV8IACT
CERESINQ1LS2UJO3AIACT
ASCORBIC ACIDPQ6CK8PD0RIACT
ZINC OXIDESOI2LOH54ZACTIB
HELIANTHUS ANNUUS (SUNFLOWER) SEED WAX42DG15CHXVIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
CETEARYL ISONONANOATEP5O01U99NIIACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
ALUMINUM STEARATEU6XF9NP8HMIACT
ETHYLENE BRASSYLATE9A87HC7RODIACT
CETYL DIMETHYLBUTYL ETHER7LAB1GXG9GIACT
ALUMINALMI26O6933IACT
C12-15 ALKYL BENZOATEA9EJ3J61HQIACT
CITRIC ACID2968PHW8QPIACT
ZINGIBER OFFICINALE (GINGER) ROOT OILSAS9Z1SVUKIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
ASCORBYL PALMITATEQN83US2B0NIACT

Source Document#

Source XML

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 1 of 1 · 1 matching rows.

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
ndc (package): 58892-362-30
ndc (product): 58892-362
ndc11 (package): 58892036230
spl id: 2f7225d0-ddfb-e19a-e063-6294a90a52a8
spl set id: 2f7225d0-ddfa-e19a-e063-6294a90a52a8