FDA.reportPublic FDA data

CoTZ Silky Foam Non-Tinted

Manufacturer
Fallien Cosmeceuticals, LTD | Custom Analytics LLC | Fragrance Manufacturing Inc. (FMI) | Keystone Industries
Effective date
2025-01-24
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:53:41

Label at a glance#

ProductCoTZ Silky Foam Non-Tinted
Active ingredientTitanium Dioxide, Zinc 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

Shake well before using. Use caution during 1 st application to reduce splatter. Apply liberally 15 minutes before sun exposure. Reapply: After 40 minutes of swimming or sweating Immediately after towel drying 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 ...

Label contents#

Full prescribing information#

Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 3%

Zinc Oxide 10%

Purpose:

OTC - PURPOSE SECTION

Sunscreen

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

  • Shake well before using.
  • Use caution during 1st application to reduce splatter.
  • Apply liberally 15 minutes before sun exposure.
  • Reapply:
    • After 40 minutes of swimming or sweating
    • Immediately after towel drying
    • 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

Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Caprylhydroxamic Acid, Caprylyl Glycol, Cellulose Gum, Ceteareth-20, Cetearyl Alcohol, Citric Acid, Disodium EDTA, Glycereth-26, Glycerin, Glyceryl Stearate, Isododecane, Isohexadecane, Methyl Methacrylate Crosspolymer, Microcrystalline Cellulose, Octyldodecyl Ecruate, Octyldodecyl Neopentanoate, Poly C10-30 Alkyl Acrylate, Polyhydroxystearic Acid, Polysorbate 80, Trans-1,3,3,3-Tetrafluoropropene, Triacontanyl PVP, Triethoxycaprylylsilane, Water

Other Information:

OTHER SAFETY INFORMATION

  • Protect this product from excessive heat and direct sun
  • Store between 68° to 104°F (20° to 40° C)
  • DO not store at temperature above 120° F

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®

Silky
Foam

Non-Tinted

SPF
30

Vanishing Zinc Oxide
MINERAL SUNCREEN

BODY

Broad Spectrum SPF 30

Water Resistant (40 Minutes)

Net Wt. 3.5 oz/100 g

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

Principal Display Panel – Can Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CoTZ®
the HEALTHIER SUNSCREEN®

Silky
Foam

Non-Tinted

SPF
30

Foaming
MINERAL SUNSCREEN

BODY

Broad Spectrum SPF 30

Water Resistant (40 Minutes)

Net Wt. 3.5 oz/100 g

Principal Display Panel – Can Label
Principal Display Panel – Can Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58892-330-012022-01-30C16284748780-1d6a99b39-d2a8-a426-e053-dadaa90af4c2Drug Facts
58892-330-012022-01-28C16284748780-1d6a99b39-d2a8-a426-e053-dadaa90af4c2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58892-330-01CoTZ Silky Foam Non-Tinted1 in 1 CARTONAEROSOL, FOAM14
58892-330-01CoTZ Silky Foam Non-Tinted100 g in 1 CANAEROSOL, FOAM1004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58892-330COTZ SILKY FOAM NON-TINTED (TITANIUM DIOXIDE, ZINC OXIDE) AEROSOL, FOAM [FALLIEN COSMECEUTICALS, LTD]4Current NDC, Legacy NDC, 2 package rows20250126_9c04b76e-ae65-4183-b475-3b8e8764db59.zip

Products#

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

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58892-33058892-330-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

Name, UNII, Kind table
NameUNIIKind
Titanium Dioxide15FIX9V2JPACTIB
Zinc OxideSOI2LOH54ZACTIB
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
BEHENYL ACRYLATE POLYMERD64PM5UT4UIACT
CAPRYLHYDROXAMIC ACIDUPY805K99WIACT
CAPRYLYL GLYCOL00YIU5438UIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMK679OBS311IACT
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
GLYCERETH-26NNE56F2N14IACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
ISODODECANEA8289P68Y2IACT
ISOHEXADECANE918X1OUF1EIACT
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMEREG97988M5QIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
OCTYLDODECYL ERUCATED4N66T98C2IACT
OCTYLDODECYL NEOPENTANOATEX8725R883TIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
POLY(METHYL METHACRYLATE; 450000 MW)Z47NNT4J11IACT
POLYSORBATE 806OZP39ZG8HIACT
1,3,3,3-TETRAFLUOROPROPENE, (1E)-5I2481UOO8IACT
TRICONTANYL POVIDONEN0SS3Q238DIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
WATER059QF0KO0RIACT

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 Silky Foam Non-TintedTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD9c04b76e-ae65-4183-b475-3b8e8764db592025-01-24WarningsExact identifier
ndc (package): 58892-330-01
ndc (product): 58892-330
ndc11 (package): 58892033001
spl id: f0097622-b48e-489a-b8a0-27bf0dae05d6
spl set id: 9c04b76e-ae65-4183-b475-3b8e8764db59

Reported adverse events (FAERS/openFDA)#

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