FDA.reportPublic FDA data

CoTZ SPF 58

Manufacturer
Fallien Cosmeceuticals, LTD. | Process Technologies & Packaging | Custom Analytics LLC
Effective date
2010-08-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:25:38

Label at a glance#

ProductCoTZ SPF 58 Sunscreen
Active ingredientTitanium Dioxide, Zinc Oxide
Label structure6 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

DRUG FACTS

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 10%

Zinc Oxide 3%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Sunscreen

INDICATIONS & USAGE SECTION

Uses: Helps prevent sunburn

  • Retains SPF up to 40 minutes of water immersion or perspiring

WARNINGS SECTION

Warnings: For external use only

  • Avoid contact with eyes. In case of eye contact, flush eyes with water thoroughly
  • Do not use if sensitive to ingredients • Discontinue use if irritation occurs. Consult a doctor or healthcare professional if irritation persists
  • For use on children less than 6 months of age, consult a doctor.
  • Keep this and all medicines out of reach of children
  • If swallowed, get medical help or contact a Poison Control Center

DOSAGE & ADMINISTRATION SECTION

Directions: Apply generously and uniformly to all exposed skin areas before exposure to sunlight

  • Continure to rub in until fading occurs, especially in hair bearing areas
  • Reapply as needed and after washing, swimming, towel drying, or sweating for maximum protection.

SPL UNCLASSIFIED SECTION

Other Information Sun Alert: limiting sun expusure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun. May stain some fabric.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Acrylates C10-30 Alkyl

Acrylates Crosspolymer,

Butylene Glycol, Butyloctyl

Salicylate, Butylparaben,

Capric/Caprylic Triglyceride,

Cetearyl Alcohol, Cetearyl

Glucoside, Cyclomethicone,

Dimethicone, EDTA,

Ethylhexyl Hydroxystearate

Benzoate, Glyceryl Stearate,

Iron Oxides, Isobutylparaben,

Isopropylparaben,

Melissa Officinalis (Balm

Mint) Extract, Octyldodecyl

Neopentanoate, PEG-100

Stearate, Phenoxyethanol,

Retinyl Palmitate,

Simethicone, Sorbitan

Laurate, Styrene/Acrylates

Copolymer, Talc, Tocopherol,

Tocopheryl Acetate,

Tricontanyl PVP, Water,

Xanthan Gum

UVA - Same Everyday

SPL UNCLASSIFIED SECTION

UVA radiation, unlike UVB, is consistently the same all day long, all month long and all year long. UVA rays present almost the same damaging effects to the skin in December at 9 am, as they do in July at 4 pm. UVA radiation is consistently damaging, and in fact, enters deeper into the skin than UVB. Since UVA damage is cumulative and penetrates through glass, everyone requires daily, year round protection.

  • Extra gentle - no chemical sunscreen filters
  • Dries clear
  • Oil & PABA free
  • Fragrance free

Manufactured exclusively for:
Fallien, West Norriton, PA 19403
www.totalblock.com

Made in USA

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel – Carton Label

NDC 58892-910-87

Dermatologist Recommended for Sensitive Skin

FALLENE CoTZ®

Contains Only Titanium & Zinc®

WATER-RESISTANT SUN PROTECTION

UVA-UVB SPF 58

Net Wt. 2.5 Oz./ 70 g

Figure
Figure

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58892-910-872019-10-21C16284748780-1956f9ecf-db45-621f-e053-dbdaa90a74adFALLENE CoTZ ®

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58892-910-87CoTZ SPF 58 Sunscreen70 g in 1 TUBECREAM701
58892-910-87CoTZ SPF 58 Sunscreen1 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58892-910COTZ SPF 58 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS, LTD.]1Legacy NDC, 2 package rows20100827_5dcc7e98-e4e9-4c7f-9e0f-7aa812e7cf22.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Titanium DioxideACTIVE INGREDIENT15FIX9V2JP1
Zinc OxideACTIVE INGREDIENTSOI2LOH54Z1
Titanium DioxideACTIVE MOIETY15FIX9V2JP1
Zinc OxideACTIVE MOIETYSOI2LOH54Z1
Alpha-TocopherolINACTIVE INGREDIENTH4N855PNZ11
Alpha-Tocopherol AcetateINACTIVE INGREDIENT9E8X80D2L01
Butylene GlycolINACTIVE INGREDIENT3XUS85K0RA1
ButylparabenINACTIVE INGREDIENT3QPI1U3FV81
Carbomer Copolymer Type BINACTIVE INGREDIENT1G56KV7BUJ1
CyclomethiconeINACTIVE INGREDIENTNMQ347994Z1
DimethiconeINACTIVE INGREDIENT92RU3N3Y1O1
Edetate DisodiumINACTIVE INGREDIENT7FLD91C86K1
Ferric Oxide YellowINACTIVE INGREDIENTEX438O2MRT1
Ferrosoferric OxideINACTIVE INGREDIENTXM0M87F3571
Glyceryl MonostearateINACTIVE INGREDIENT230OU9XXE41
IsobutylparabenINACTIVE INGREDIENT0QQJ25X58G1
IsopropylparabenINACTIVE INGREDIENTA6EOX47QK01
Lemon Balm OilINACTIVE INGREDIENTMJ76269K9S1
Medium-Chain TriglyceridesINACTIVE INGREDIENTC9H2L21V7U1
Octyldodecyl NeopentanoateINACTIVE INGREDIENTX8725R883T1
PhenoxyethanolINACTIVE INGREDIENTHIE492ZZ3T1
Polyoxyl 100 StearateINACTIVE INGREDIENTYD01N1999R1
Sorbitan MonolaurateINACTIVE INGREDIENT6W9PS8B71J1
TalcINACTIVE INGREDIENT7SEV7J4R1U1
Vitamin A PalmitateINACTIVE INGREDIENT1D1K0N0VVC1
WaterINACTIVE INGREDIENT059QF0KO0R1
Xanthan GumINACTIVE INGREDIENTTTV12P4NEE1

Products#

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

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58892-91058892-910-87

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
NameUNIIKind
Titanium Dioxide15FIX9V2JPACTIB
Zinc OxideSOI2LOH54ZACTIB
Butylene Glycol3XUS85K0RAIACT
Butylparaben3QPI1U3FV8IACT
Medium-Chain TriglyceridesC9H2L21V7UIACT
Carbomer Copolymer Type B1G56KV7BUJIACT
CyclomethiconeNMQ347994ZIACT
Dimethicone92RU3N3Y1OIACT
Edetate Disodium7FLD91C86KIACT
Glyceryl Monostearate230OU9XXE4IACT
Ferric Oxide YellowEX438O2MRTIACT
Ferrosoferric OxideXM0M87F357IACT
Isobutylparaben0QQJ25X58GIACT
IsopropylparabenA6EOX47QK0IACT
Lemon Balm OilMJ76269K9SIACT
Octyldodecyl NeopentanoateX8725R883TIACT
Polyoxyl 100 StearateYD01N1999RIACT
PhenoxyethanolHIE492ZZ3TIACT
Vitamin A Palmitate1D1K0N0VVCIACT
Sorbitan Monolaurate6W9PS8B71JIACT
Talc7SEV7J4R1UIACT
Alpha-TocopherolH4N855PNZ1IACT
Alpha-Tocopherol Acetate9E8X80D2L0IACT
Water059QF0KO0RIACT
Xanthan GumTTV12P4NEEIACT

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 5 · 266 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
Alpha-Tocopherol.ALPHA.-TOCOPHEROLH4N855PNZ1TABLET, FILM COATED / ORAL246 mgExact identifier — unii candidate
10 equally ranked IID candidates
Medium-Chain TriglyceridesMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UCREAM / TOPICAL3300 mgExact identifier — unii candidate
18 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KGEL / TRANSDERMAL1 mgExact identifier — unii candidate
77 equally ranked IID candidates
Ferrosoferric OxideFERROSOFERRIC OXIDEXM0M87F357POWDER, FOR SUSPENSION / ORALNAExact identifier — unii candidate
10 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KSOLUTION / ORAL432 mgExact identifier — unii candidate
77 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KINJECTION, SOLUTION / SUBCUTANEOUS2 mgExact identifier — unii candidate
77 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KOINTMENT / TOPICAL1 mgExact identifier — unii candidate
77 equally ranked IID candidates
Ferric Oxide YellowFERRIC OXIDE YELLOWEX438O2MRTSUSPENSION / ORAL6 mgExact identifier — unii candidate
20 equally ranked IID candidates
Xanthan GumXANTHAN GUMTTV12P4NEEPOWDER, FOR SUSPENSION / ORAL600 mgExact identifier — unii candidate
29 equally ranked IID candidates
ButylparabenBUTYLPARABEN3QPI1U3FV8CAPSULE, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
15 equally ranked IID candidates
Medium-Chain TriglyceridesMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UCAPSULE / ORAL4771 mgExact identifier — unii candidate
18 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KINJECTION / INTRAVASCULAR0.48 mgExact identifier — unii candidate
77 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KAEROSOL, FOAM / RECTAL2 mgExact identifier — unii candidate
77 equally ranked IID candidates
Sorbitan MonolaurateSORBITAN MONOLAURATE6W9PS8B71JTABLET, FILM COATED / ORAL800 mgExact identifier — unii candidate
12 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KGEL / TOPICAL24 mgExact identifier — unii candidate
77 equally ranked IID candidates
Butylene GlycolBUTYLENE GLYCOL3XUS85K0RASYSTEM / TOPICAL1400 mgExact identifier — unii candidate
2 equally ranked IID candidates
TalcTALC7SEV7J4R1UGRANULE, FOR SUSPENSION / ORAL296 mgExact identifier — unii candidate
35 equally ranked IID candidates
Alpha-Tocopherol.ALPHA.-TOCOPHEROLH4N855PNZ1TABLET, CHEWABLE / ORAL0.1 mgExact identifier — unii candidate
10 equally ranked IID candidates
Glyceryl MonostearateGLYCERYL MONOSTEARATE230OU9XXE4SUPPOSITORY / RECTAL35 mgExact identifier — unii candidate
21 equally ranked IID candidates
Medium-Chain TriglyceridesMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UOINTMENT / TOPICAL20 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
Medium-Chain TriglyceridesMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UAEROSOL, FOAM / TOPICAL10.87 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KPOWDER, FOR SUSPENSION / ORAL285 mgExact identifier — unii candidate
77 equally ranked IID candidates
Alpha-Tocopherol.ALPHA.-TOCOPHEROLH4N855PNZ1FILM, SOLUBLE / BUCCAL0.07 mgExact identifier — unii candidate
10 equally ranked IID candidates
Glyceryl MonostearateGLYCERYL MONOSTEARATE230OU9XXE4TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL23 mgExact identifier — unii candidate
21 equally ranked IID candidates
ButylparabenBUTYLPARABEN3QPI1U3FV8SUSPENSION / ORAL12 mgExact identifier — unii candidate
15 equally ranked IID candidates
TalcTALC7SEV7J4R1UTABLET / RECTAL32.4 mgExact identifier — unii candidate
35 equally ranked IID candidates
Ferrosoferric OxideFERROSOFERRIC OXIDEXM0M87F357CAPSULE, DELAYED RELEASE / ORAL6 mgExact identifier — unii candidate
10 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KSOLUTION / RECTAL97 mgExact identifier — unii candidate
77 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KTABLET / ORAL100 mgExact identifier — unii candidate
77 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KSYSTEM / TOPICAL126 mgExact identifier — unii candidate
77 equally ranked IID candidates
Xanthan GumXANTHAN GUMTTV12P4NEESUSPENSION / TOPICAL0.11 %w/vExact identifier — unii candidate
29 equally ranked IID candidates
Medium-Chain TriglyceridesMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7USPRAY / TOPICAL540 mgExact identifier — unii candidate
18 equally ranked IID candidates
TalcTALC7SEV7J4R1USUSPENSION / ORAL234 mgExact identifier — unii candidate
35 equally ranked IID candidates
Ferrosoferric OxideFERROSOFERRIC OXIDEXM0M87F357TABLET, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
10 equally ranked IID candidates
Xanthan GumXANTHAN GUMTTV12P4NEETABLET, EXTENDED RELEASE / ORAL528 mgExact identifier — unii candidate
29 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KINJECTION / INTRAVENOUS10 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KTABLET, CHEWABLE / ORAL1 mgExact identifier — unii candidate
77 equally ranked IID candidates
Sorbitan MonolaurateSORBITAN MONOLAURATE6W9PS8B71JAEROSOL / TOPICAL4.74 %w/wExact identifier — unii candidate
12 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KINJECTION / INTRALESIONAL0.05 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
CyclomethiconeCYCLOMETHICONENMQ347994ZLOTION / TOPICAL3510 mgExact identifier — unii candidate
5 equally ranked IID candidates
ButylparabenBUTYLPARABEN3QPI1U3FV8LOTION / TOPICAL4 mgExact identifier — unii candidate
15 equally ranked IID candidates
Ferric Oxide YellowFERRIC OXIDE YELLOWEX438O2MRTTABLET / ORAL24 mgExact identifier — unii candidate
20 equally ranked IID candidates
TalcTALC7SEV7J4R1UGUM, CHEWING / BUCCALNAExact identifier — unii candidate
35 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KSUSPENSION/ DROPS / AURICULAR (OTIC)0.01 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KELIXIR / ORAL1.3 mg/5mlExact identifier — unii candidate
77 equally ranked IID candidates
Sorbitan MonolaurateSORBITAN MONOLAURATE6W9PS8B71JGEL / TOPICAL1 %w/wExact identifier — unii candidate
12 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KLIQUID / NASAL2 mg/1mlExact identifier — unii candidate
77 equally ranked IID candidates
Sorbitan MonolaurateSORBITAN MONOLAURATE6W9PS8B71JEMULSION / ORALNAExact identifier — unii candidate
12 equally ranked IID candidates
Medium-Chain TriglyceridesMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7USPRAY, METERED / SUBLINGUAL110 mgExact identifier — unii candidate
18 equally ranked IID candidates
TalcTALC7SEV7J4R1UTABLET, COATED / ORAL320.75 mgExact identifier — unii candidate
35 equally ranked IID candidates
Xanthan GumXANTHAN GUMTTV12P4NEESUSPENSION, EXTENDED RELEASE / ORAL186.8 mgExact identifier — unii candidate
29 equally ranked IID candidates
Polyoxyl 100 StearatePEG-100 MONOSTEARATEYD01N1999RCREAM / TOPICAL552 mgExact identifier — unii candidate
3 equally ranked IID candidates
Xanthan GumXANTHAN GUMTTV12P4NEETABLET, CHEWABLE, EXTENDED RELEASE / ORAL6 mgExact identifier — unii candidate
29 equally ranked IID candidates
Glyceryl MonostearateGLYCERYL MONOSTEARATE230OU9XXE4CAPSULE / ORAL13.75 mgExact identifier — unii candidate
21 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KSUSPENSION / AURICULAR (OTIC)0.01 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
Glyceryl MonostearateGLYCERYL MONOSTEARATE230OU9XXE4TABLET, CHEWABLE / ORAL1 mgExact identifier — unii candidate
21 equally ranked IID candidates
TalcTALC7SEV7J4R1UTABLET / ORAL1000 mgExact identifier — unii candidate
35 equally ranked IID candidates
Medium-Chain TriglyceridesMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UTABLET / ORAL2 mgExact identifier — unii candidate
18 equally ranked IID candidates
Medium-Chain TriglyceridesMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7USUSPENSION / ORAL10170 mgExact identifier — unii candidate
18 equally ranked IID candidates
Xanthan GumXANTHAN GUMTTV12P4NEETABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL36 mgExact identifier — unii candidate
29 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
62bf906c-ca32-4c8f-be85-a6832d1351ff5dcc7e98-e4e9-4c7f-9e0f-7aa812e7cf222010-08-04WarningsExact identifier
spl id: 62bf906c-ca32-4c8f-be85-a6832d1351ff
spl set id: 5dcc7e98-e4e9-4c7f-9e0f-7aa812e7cf22

Reported adverse events (FAERS/openFDA)#

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