FDA.reportPublic FDA data

CoTZ Face Moisture

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 00:52:21

Label at a glance#

ProductCoTZ Face Moisture
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. Reapply: - After 80 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...

Label contents#

Full prescribing information#

Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 16%

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

OTC - KEEP OUT OF REACH OF CHILDREN 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 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:

INACTIVE INGREDIENT SECTION

Capric/Caprylic Triglyceride, Ceramide 3, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Iron Oxide, Methicone, PEG-10 Dimethicone, Polyhydroxystearic Acid, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer

Other Information:

OTHER SAFETY INFORMATION

  • Protect this product from excessive heat and direct sun
  • May stain some fabrics

Manufactured Exclusively For:
CoTZ® Skincare
Norristown, PA 19403

www.cotzskincare.com

Principal Display Panel – Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CoTZ®
the HEALTHIER SUNSCREEN®

Face
Moisture

Lightly Tinted

SPF
35

Hydrate & Protect
MINERAL SUNCREEN

FACE

Broad Spectrum SPF 35

Water Resistant (80 Minutes)

Net Wt. 1.5 oz/42.5 g

Principal Display Panel – Carton Label
Principal Display Panel – Carton Label

Principal Display Panel – Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CoTZ®
the HEALTHIER SUNSCREEN®

Face
Moisture

Lightly Tinted

SPF
35

Hydrate & Protect
MINERAL SUNCREEN

FACE

Broad Spectrum SPF 35

Water Resistant (80 Minutes)

Net Wt. 1.5 oz/42.5 g

Principal Display Panel – Tube Label
Principal Display Panel – Tube Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58892-360-42CoTZ Face Moisture1 in 1 CARTONCREAM13
58892-360-42CoTZ Face Moisture42.5 g in 1 TUBECREAM42.53

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58892-360COTZ FACE MOISTURE (ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS, LTD]3Current NDC, Legacy NDC, 2 package rows20250112_db682516-6c8f-4009-a9ec-e21dfc64ce15.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58892-36058892-360-42

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
Zinc OxideSOI2LOH54ZACTIB
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CERAMIDE NP4370DF050BIACT
Cyclomethicone 6XHK3U310BAIACT
Cyclomethicone 50THT5PCI0RIACT
Dimethicone 20H8YMB5QY0DIACT
Dimethicone Crosspolymer (450000 MPA.S AT 12% in Cyclopentasiloxane)UF7620L1W6IACT
Dimethicone/Vinyl Dimethicone Crosspolymer (Soft Particle)9E4CO0W6C5IACT
Dimethiconol (2000 CST)T74O12AN6YIACT
Brown Iron Oxide1N032N7MFOIACT
Hydrogen Dimethicone (20 CST)12Z59IF64NIACT
PEG-10 Dimethicone (600 CST)8PR7V1SVM0IACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER9NH1UDD2RRIACT

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 FACE MOISTUREZINC OXIDEFallien Cosmeceuticals Ltd.509d9a74-bc8d-c9c1-e063-6394a90a403d2026-04-29WarningsExact identifier
ndc (product): 58892-360
CoTZ Face MoistureZINC OXIDEFallien Cosmeceuticals, LTDdb682516-6c8f-4009-a9ec-e21dfc64ce152025-01-09WarningsExact identifier
ndc (package): 58892-360-42
ndc (product): 58892-360
ndc11 (package): 58892036042
spl id: fdaec1a9-d74a-4eb7-97f6-a0e47d983b22
spl set id: db682516-6c8f-4009-a9ec-e21dfc64ce15

Reported adverse events (FAERS/openFDA)#

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