FDA.reportPublic FDA data

CoTZ Kids

Manufacturer
Fallien Cosmeceuticals, LTD. | Fragrance Manufacturing Inc. | Custom Analytics LLC
Effective date
2025-08-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:10:56

Label at a glance#

ProductCoTZ Kids
Active ingredientZINC OXIDE
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. Use a water-resistant product if swimming or sweating. Reapply at least every 2 hours. Children under 6 months: Ask a doctor. Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad-Spectrum SPF value of 15 or higher and other sun protection measures inclu...

Label contents#

Full prescribing information#

Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 20%

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 broken or damaged 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 reach of children. If swallowed, get medical help or contact a poison control center right away.

Warnings:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

Directions:

DOSAGE & ADMINISTRATION SECTION

Apply liberally 15 minutes before sun exposure. Use a water-resistant product if swimming or sweating. Reapply at least every 2 hours. Children under 6 months: Ask a doctor. Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad-Spectrum SPF value of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10 a.m. - 2 p.m. Wear long-sleeved shirts, pants, hats and sunglasses.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

C12-15 Alkyl Benzoate, Caprylhydroxamic Acid, Caprylyl Glycol, Cetyl PEG/PPG - 10/1 Dimethicone, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Disodium EDTA, Glycerin, Hydrogen Dimethicone, Microcrystalline Wax, PEG-10 Dimethicone, PEG-30 Dipolyhydroxystearate, Polyglyceryl-4 Isostearate, Polyhydroxystearic Acid, Polysorbate 20, Sodium Chloride, Stearyl Dimethicone, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Triethanolamine, Triethoxycaprylylsilane, Water

Other Information:

OTHER SAFETY INFORMATION

For 6 Months and older

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package LabelPackage Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58892-619-05CoTZ Kids5 g in 1 TUBECREAM51

Products#

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

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58892-61958892-619-05

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
ZINC OXIDESOI2LOH54ZACTIB
CAPRYLHYDROXAMIC ACIDUPY805K99WIACT
CAPRYLYL GLYCOL00YIU5438UIACT
CYCLOPENTASILOXANE0THT5PCI0RIACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
DIMETHICONOL (2000 CST)T74O12AN6YIACT
HYDROGEN DIMETHICONE (20 CST)12Z59IF64NIACT
MICROCRYSTALLINE WAXXOF597Q3KYIACT
POLYSORBATE 207T1F30V5YHIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
DIMETHICONE92RU3N3Y1OIACT
POLYGLYCERYL-4 ISOSTEARATE820DPX33S7IACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
WATER059QF0KO0RIACT
STEARYL DIMETHICONE (400 MPA.S AT 50C)R327X197HYIACT
TRIETHANOLAMINE9O3K93S3TKIACT
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4)8INO2K35FAIACT
CYCLOHEXASILOXANEXHK3U310BAIACT
DIMETHICONE CROSSPOLYMERUF7620L1W6IACT
GLYCERINPDC6A3C0OXIACT
PEG-30 DIPOLYHYDROXYSTEARATE9713Q0S7FOIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
TETRAHEXYLDECYL ASCORBATE9LBV3F07AZIACT
PEG-10 DIMETHICONE (600 CST)8PR7V1SVM0IACT
SODIUM CHLORIDE451W47IQ8XIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
C12-15 ALKYL BENZOATEA9EJ3J61HQIACT

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CoTZ KidsZINC OXIDEFallien Cosmeceuticals, LTD.3ca8742f-67cb-a25c-e063-6394a90a46382025-08-18WarningsExact identifier
ndc (product): 58892-619
CoTZ KidsZINC OXIDEFallien Cosmeceuticals, LTD.3ca914e2-cd53-42bf-e063-6294a90a70822025-08-18WarningsExact identifier
ndc (package): 58892-619-05
ndc (product): 58892-619
ndc11 (package): 58892061905
spl id: 3ca914e2-cd54-42bf-e063-6294a90a7082
spl set id: 3ca914e2-cd53-42bf-e063-6294a90a7082

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.