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.
CoTZ Baby
- Manufacturer
- Fallien Cosmeceuticals, LTD | Custom Analytics LLC | Fragrance Manufacturing Inc. (FMI)
- Effective date
- 2025-01-09
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-06-01 00:51:45
Label at a glance#
ProductCoTZ Baby
Active ingredientZinc Oxide
Label structure10 sections
Dosage and administration
Apply liberally 15 minutes before sun exposure. Reapply: - After 40 minutes of swimming or sweating - Immediately after towel drying - At least every two 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 p...
Contacts and useful links#
Websitewww.cotzskincare.com
www.cotzskincare.com
www.cotzskincare.comLabel contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
DRUG FACTS
Active Ingredients:
Zinc Oxide 20%
Purpose:
Sunscreen
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.
Warnings:
For external use only.
OTC - DO NOT USE SECTION
Do not use on damaged or broken skin.
OTC - STOP USE SECTION
Stop use and ask a doctor if rash occurs.
OTC - WHEN USING SECTION
When using this product, keep out of eyes. Rinse with water to remove.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions:
- Apply liberally 15 minutes before sun exposure.
Reapply:
- After 40 minutes of swimming or sweating
- Immediately after towel drying
- At least every two 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:
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 Dimethicome, PEG-30 Dipoly-hydroxystearate, Polyglyceryl-4 Isostearate, Polyhydroxystearic Acid, Polysorbate 20, Sodium Chloride, Stearyl Dimethicone, Tetrahexydecyl Ascorbate, Tocopheryl Acetate, Triethanolamine, Triethoxycaprylylsilane, Water
Other Information:
- Protect this product from excessive heat and direct sun.
- May stain some fabrics.
Manufactured Exclusively For:
CoTZ® Skincare
Norristown, PA 19403
Principal Display Panel – CoTZ Baby Tube Label
CoTZ®
the HEALTHIER
SUNSCREEN®
Baby
Non-Tinted
SPF
40
Soothing & Gentle
MINERAL SUNSCREEN
For 6+ Months
Broad Spectrum SPF 40
Water Resistant (40 minutes)
Net Wt. 3.5 oz/100 g
Principal Display Panel – CoTZ Baby Carton Label
CoTZ®
the HEALTHIER
SUNSCREEN®
Baby
Non-Tinted
SPF
40
Soothing & Gentle
MINERAL SUNSCREEN
For 6+ Months
Broad Spectrum SPF 40
Water Resistant (40 minutes)
Net Wt. 3.5 oz/100 g
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 58892-618-01 | CoTZ Baby | 1 in 1 CARTON | CREAM | 1 | 3 | |
| 58892-618-01 | CoTZ Baby | 100 g in 1 TUBE | CREAM | 100 | 3 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- CoTZ Baby
- Zinc Oxide
- ALKYL (C12-15) BENZOATE
- CAPRYLHYDROXAMIC ACID
- CAPRYLYL GLYCOL
- CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5)
- CYCLOMETHICONE 6
- CYCLOMETHICONE 5
- DIMETHICONE 100
- DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE)
- DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)
- DIMETHICONOL (2000 CST)
- EDETATE DISODIUM
- GLYCERIN
- HYDROGEN DIMETHICONE (20 CST)
- MICROCRYSTALLINE WAX
- PEG-10 DIMETHICONE (600 CST)
- PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW)
- POLYGLYCERYL-4 ISOSTEARATE
- POLYHYDROXYSTEARIC ACID (2300 MW)
- POLYSORBATE 20
- SODIUM CHLORIDE
- STEARYL DIMETHICONE (400 MPA.S AT 50C)
- TETRAHEXYLDECYL ASCORBATE
- .ALPHA.-TOCOPHEROL ACETATE
- TROLAMINE
- TRIETHOXYCAPRYLYLSILANE
- WATER
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 58892-618 | 58892-618-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| CoTZ Baby | ZINC OXIDE | Fallien Cosmeceuticals, LTD | 17cc12c7-5af8-413f-b205-31ac150583e2 | 2025-01-09 | Warnings | 58892-618-01 58892-618 58892061801 15704611-83f8-4ccf-890b-7e67486c9a04 17cc12c7-5af8-413f-b205-31ac150583e2 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.