FDA.reportPublic FDA data

Cotz Sensitive SPF 40

Manufacturer
Fallien Cosmeceuticals, LTD. | Custom Analytics LLC | Process Technologies & Packaging
Effective date
2025-03-31
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:58:36

Label at a glance#

ProductCotz Sensitive SPF 40 Sunscreen
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 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...

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

OTC - DO NOT USE SECTION

For external use only. 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:

DOSAGE & ADMINISTRATION SECTION

  • 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:

INACTIVE INGREDIENT SECTION

C12-15 Alkyl Benzoate, Caprylhydroxamic Acid, Caprylyl Glycol, Cetyl PEG/PPG10/1 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, Tetrahexydecyl Ascorbate, Tocopheryl Acetate, Triethanolamine, Triethoxycaprylylsilane, Water

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 – CoTZ Sensitive Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CoTZ®

the HEALTHIER
SUNSCREEN®

Sensitive

Non-Tinted

SPF
40

Gentle Zinc Oxide

MINERAL SUNSCREEN

FACE & BODY

Broad Spectrum SPF 40

Water Resistant (40 minutes)

Net Wt. 3.5 oz/100 g

Principal Display Panel – CoTZ Sensitive Tube Label
Principal Display Panel – CoTZ Sensitive Tube Label

Principal Display Panel – CoTZ Sensitive Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CoTZ®

the HEALTHIER
SUNSCREEN®

Sensitive

Non-Tinted

SPF
40

Gentle Zinc Oxide

MINERAL SUNSCREEN

FACE & BODY

Broad Spectrum SPF 40

Water Resistant (40 minutes)

Net Wt. 3.5 oz/100 g

Principal Display Panel – CoTZ Sensitive Carton Label
Principal Display Panel – CoTZ Sensitive Carton Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58892-418-012025-04-02C16284748780-19855d018-e4b6-cd31-e053-dbdaa90ab51a885a674b-3457-4dfe-a801-529094b00499
58892-418-012019-11-27C16284748780-19855d018-e4b6-cd31-e053-dbdaa90ab51a885a674b-3457-4dfe-a801-529094b00499

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58892-418-01Cotz Sensitive SPF 40 Sunscreen100 g in 1 TUBELOTION1002
58892-418-01Cotz Sensitive SPF 40 Sunscreen1 in 1 CARTONLOTION12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58892-418COTZ SENSITIVE SPF 40 SUNSCREEN (ZINC OXIDE) LOTION [FALLIEN COSMECEUTICALS, LTD.]2Current NDC, Legacy NDC, 2 package rows20250406_885a674b-3457-4dfe-a801-529094b00499.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Zinc OxideACTIVE INGREDIENTSOI2LOH54Z1
Zinc OxideACTIVE MOIETYSOI2LOH54Z1
.Alpha.-Tocopherol AcetateINACTIVE INGREDIENT9E8X80D2L01
Alkyl (C12-15) BenzoateINACTIVE INGREDIENTA9EJ3J61HQ1
Caprylhydroxamic AcidINACTIVE INGREDIENTUPY805K99W1
Caprylyl GlycolINACTIVE INGREDIENT00YIU5438U1
Cetyl PEG/PPG-10/1 Dimethicone (HLB 5)INACTIVE INGREDIENT035JKJ76MT1
Cyclomethicone 5INACTIVE INGREDIENT0THT5PCI0R1
Cyclomethicone 6INACTIVE INGREDIENTXHK3U310BA1
Dimethicone 100INACTIVE INGREDIENTRO266O364U1
Dimethicone/Diene Dimethicone CrosspolymerINACTIVE INGREDIENTRSA9I561OK1
Edetate DisodiumINACTIVE INGREDIENT7FLD91C86K1
Methicone (20 cst)INACTIVE INGREDIENT6777U11MKT1
Microcrystalline WaxINACTIVE INGREDIENTXOF597Q3KY1
PEG-10 Dimethicone (600 cst)INACTIVE INGREDIENT8PR7V1SVM01
PEG-30 DipolyhydroxystearateINACTIVE INGREDIENT9713Q0S7FO1
Polyglyceryl-4 IsostearateINACTIVE INGREDIENT820DPX33S71
Polyhydroxystearic Acid (2300 MW)INACTIVE INGREDIENTYXH47AOU0F1
Polysorbate 20INACTIVE INGREDIENT7T1F30V5YH1
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8X1
Stearyl Dimethicone (400 MPA.S AT 50C)INACTIVE INGREDIENTR327X197HY1
Tetrahexyldecyl AscorbateINACTIVE INGREDIENT9LBV3F07AZ1
TriethoxycaprylylsilaneINACTIVE INGREDIENTLDC331P08E1
TrolamineINACTIVE INGREDIENT9O3K93S3TK1
WaterINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58892-41858892-418-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
Zinc OxideSOI2LOH54ZACTIB
Alkyl (C12-15) BenzoateA9EJ3J61HQIACT
Caprylhydroxamic AcidUPY805K99WIACT
Caprylyl Glycol00YIU5438UIACT
Cetyl PEG/PPG-10/1 Dimethicone (HLB 5)035JKJ76MTIACT
Cyclomethicone 6XHK3U310BAIACT
Cyclomethicone 50THT5PCI0RIACT
Dimethicone 100RO266O364UIACT
Dimethicone/Diene Dimethicone CrosspolymerRSA9I561OKIACT
Edetate Disodium7FLD91C86KIACT
Methicone (20 cst)6777U11MKTIACT
Microcrystalline WaxXOF597Q3KYIACT
PEG-10 Dimethicone (600 cst)8PR7V1SVM0IACT
PEG-30 Dipolyhydroxystearate9713Q0S7FOIACT
Polyglyceryl-4 Isostearate820DPX33S7IACT
Polyhydroxystearic Acid (2300 MW)YXH47AOU0FIACT
Polysorbate 207T1F30V5YHIACT
Sodium Chloride451W47IQ8XIACT
Stearyl Dimethicone (400 MPA.S AT 50C)R327X197HYIACT
Tetrahexyldecyl Ascorbate9LBV3F07AZIACT
.Alpha.-Tocopherol Acetate9E8X80D2L0IACT
Trolamine9O3K93S3TKIACT
TriethoxycaprylylsilaneLDC331P08EIACT
Water059QF0KO0RIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 26 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
.Alpha.-Tocopherol Acetate.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0CAPSULE / ORAL2 mgExact identifier — unii candidate
6 equally ranked IID candidates
TrolamineTROLAMINE9O3K93S3TKLOTION / TOPICAL360 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Dimethicone 100DIMETHICONE 100RO266O364UGEL / TOPICAL0.1 %w/wExact identifier — unii+route
2 equally ranked IID candidates
Microcrystalline WaxMICROCRYSTALLINE WAXXOF597Q3KYGEL / TOPICALNAExact identifier — unii+route
4 equally ranked IID candidates
.Alpha.-Tocopherol Acetate.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0FILM / BUCCAL0.09 mgExact identifier — unii candidate
6 equally ranked IID candidates
Polysorbate 20POLYSORBATE 207T1F30V5YHLOTION / TOPICAL2000 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Polysorbate 20POLYSORBATE 207T1F30V5YHLOTION / TOPICAL2000 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XLOTION / TOPICAL0.3 %w/vExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Cyclomethicone 5CYCLOMETHICONE 50THT5PCI0RCREAM, AUGMENTED / TOPICAL260 mgExact identifier — unii+route
6 equally ranked IID candidates
Cyclomethicone 5CYCLOMETHICONE 50THT5PCI0RCREAM, AUGMENTED / TOPICAL260 mgExact identifier — unii+route
6 equally ranked IID candidates
Microcrystalline WaxMICROCRYSTALLINE WAXXOF597Q3KYOINTMENT / TOPICAL3575 mgExact identifier — unii+route
4 equally ranked IID candidates
Microcrystalline WaxMICROCRYSTALLINE WAXXOF597Q3KYOINTMENT / TOPICAL3575 mgExact identifier — unii+route
4 equally ranked IID candidates
Dimethicone 100DIMETHICONE 100RO266O364UGEL / TOPICAL0.1 %w/wExact identifier — unii+route
2 equally ranked IID candidates
Cyclomethicone 5CYCLOMETHICONE 50THT5PCI0RAEROSOL / TOPICAL2.5 %w/wExact identifier — unii+route
6 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KLOTION / TOPICAL22 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Cyclomethicone 5CYCLOMETHICONE 50THT5PCI0RAEROSOL, FOAM / TOPICAL144 mgExact identifier — unii+route
6 equally ranked IID candidates
.Alpha.-Tocopherol Acetate.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0TABLET / ORAL0.5 mgExact identifier — unii candidate
6 equally ranked IID candidates
Cyclomethicone 5CYCLOMETHICONE 50THT5PCI0RAEROSOL, FOAM / TOPICAL144 mgExact identifier — unii+route
6 equally ranked IID candidates
.Alpha.-Tocopherol Acetate.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0CAPSULE / ORAL2 mgExact identifier — unii candidate
6 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KLOTION / TOPICAL22 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Cyclomethicone 5CYCLOMETHICONE 50THT5PCI0RAEROSOL / TOPICAL2.5 %w/wExact identifier — unii+route
6 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XLOTION / TOPICAL0.3 %w/vExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Microcrystalline WaxMICROCRYSTALLINE WAXXOF597Q3KYGEL / TOPICALNAExact identifier — unii+route
4 equally ranked IID candidates
TrolamineTROLAMINE9O3K93S3TKLOTION / TOPICAL360 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
.Alpha.-Tocopherol Acetate.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0TABLET / ORAL0.5 mgExact identifier — unii candidate
6 equally ranked IID candidates
.Alpha.-Tocopherol Acetate.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0FILM / BUCCAL0.09 mgExact identifier — unii candidate
6 equally ranked IID candidates

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 Sensitive SPF 40 SunscreenZINC OXIDEFallien Cosmeceuticals, LTD.885a674b-3457-4dfe-a801-529094b004992025-03-31WarningsExact identifier
ndc (package): 58892-418-01
ndc (product): 58892-418
ndc11 (package): 58892041801
spl id: 42e4a18c-6169-4411-b1b0-918d4cf744e6
spl set id: 885a674b-3457-4dfe-a801-529094b00499

Reported adverse events (FAERS/openFDA)#

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