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 Plus SPF 58
- Manufacturer
- Fallien Cosmeceuticals, LTD. | Custom Analytics LLC | Process Technologies & Packaging
- Effective date
- 2013-01-02
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 22:34:12
Label at a glance#
ProductCotz Plus SPF 58 Sunscreen
Active ingredientTitanium Dioxide, Zinc Oxide
Label structure9 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 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 ...
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
DRUG FACTS
Active Ingredients:
Titanium Dioxide 10%
Zinc Oxide 3%
Purpose
Sunscreen
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 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:
Acrylates C10-30 Alkyl Acrylates Crosspolymer, Butylene Glycol, Butyloctyl Salicylate, Butylparaben, Capric/Caprylic Triglyceride, Cetearyl Alcohol, Cetearyl Glucoside, Cyclomethicone, Dimethicone, Ethylhexyl Hydroxystearate Benzoate, Glyceryl Stearate, Iron Oxides, Isobutylparaben, Isopropylparaben, Melissa Officinalis (Balm Mint) Leaf Extract, Octyldodecyl Neopentanoate, PEG-100 Stearate, Phenoxyethanol, Retinyl Palmitate, Simethicone, Sorbitan Laurate, Styrene/Acrylates Copolymer, Talc, Tocopherol, Tocopheryl Acetate, Tricontanyl PVP, Trisodium EDTA, Water, Xanthan Gum
Other Information:
- Protect this product from excessive heat and direct sun
- May stain some fabrics
Principal Display Panel – 2.5 oz Carton Label
DERMATOLOGIST RECOMMENDED
CoTZ®
PLUS
The Healthier SunscreenTM
Balanced Mineral Complex™
#1 Rated UV Protection*
Will Not Irritate or Sting
Helps Prevent Heat Build-Up in Skin
which can Damage the Dermis
100% Free of:
Chemical Sunscreens & Oils
SPF 58 Broad
Spectrum
UVA-UVB
Blends
Translucent
Water
Resistant
(40 minutes)
Net Wt. 2.5 oz/70.0 g
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 58892-070-58 | 2019-11-27 | C162847 | 48780-1 | 9855d018-d700-cd31-e053-dbdaa90ab51a | 649dbe58-a0a1-494a-a1d7-9c6f3cd83bc6 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 58892-070-58 | Cotz Plus SPF 58 Sunscreen | 70 g in 1 TUBE | CREAM | 70 | 1 | |
| 58892-070-58 | Cotz Plus SPF 58 Sunscreen | 1 in 1 CARTON | CREAM | 1 | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Titanium Dioxide | ACTIVE INGREDIENT | 15FIX9V2JP | 1 | |
| Zinc Oxide | ACTIVE INGREDIENT | SOI2LOH54Z | 1 | |
| Titanium Dioxide | ACTIVE MOIETY | 15FIX9V2JP | 1 | |
| Zinc Oxide | ACTIVE MOIETY | SOI2LOH54Z | 1 | |
| .Alpha.-Tocopherol Acetate | INACTIVE INGREDIENT | 9E8X80D2L0 | 1 | |
| Butylene Glycol | INACTIVE INGREDIENT | 3XUS85K0RA | 1 | |
| Butylparaben | INACTIVE INGREDIENT | 3QPI1U3FV8 | 1 | |
| Carbomer Copolymer Type B (Allyl Pentaerythritol Crosslinked) | INACTIVE INGREDIENT | 809Y72KV36 | 1 | |
| Cetearyl Glucoside | INACTIVE INGREDIENT | 09FUA47KNA | 1 | |
| Cetostearyl Alcohol | INACTIVE INGREDIENT | 2DMT128M1S | 1 | |
| Cyclomethicone | INACTIVE INGREDIENT | NMQ347994Z | 1 | |
| Dimethicone | INACTIVE INGREDIENT | 92RU3N3Y1O | 1 | |
| Edetate Trisodium | INACTIVE INGREDIENT | 420IP921MB | 1 | |
| Ferric Oxide Yellow | INACTIVE INGREDIENT | EX438O2MRT | 1 | |
| Ferrosoferric Oxide | INACTIVE INGREDIENT | XM0M87F357 | 1 | |
| Glyceryl Monostearate | INACTIVE INGREDIENT | 230OU9XXE4 | 1 | |
| Isobutylparaben | INACTIVE INGREDIENT | 0QQJ25X58G | 1 | |
| Isopropylparaben | INACTIVE INGREDIENT | A6EOX47QK0 | 1 | |
| Medium-Chain Triglycerides | INACTIVE INGREDIENT | C9H2L21V7U | 1 | |
| Melissa Officinalis Leaf | INACTIVE INGREDIENT | 50D2ZE9219 | 1 | |
| Octyldodecyl Neopentanoate | INACTIVE INGREDIENT | X8725R883T | 1 | |
| PEG-100 Stearate | INACTIVE INGREDIENT | YD01N1999R | 1 | |
| Phenoxyethanol | INACTIVE INGREDIENT | HIE492ZZ3T | 1 | |
| Sorbitan Monolaurate | INACTIVE INGREDIENT | 6W9PS8B71J | 1 | |
| Talc | INACTIVE INGREDIENT | 7SEV7J4R1U | 1 | |
| Tocopherol | INACTIVE INGREDIENT | R0ZB2556P8 | 1 | |
| Tricontanyl Povidone (4 Tricontanyl Branches/Repeat) | INACTIVE INGREDIENT | N0SS3Q238D | 1 | |
| Vitamin A Palmitate | INACTIVE INGREDIENT | 1D1K0N0VVC | 1 | |
| Water | INACTIVE INGREDIENT | 059QF0KO0R | 1 | |
| Xanthan Gum | INACTIVE INGREDIENT | TTV12P4NEE | 1 |
Products#
Every source-derived product name is available through these pages.
- Cotz Plus SPF 58 Sunscreen
- Titanium Dioxide, Zinc Oxide
- Titanium Dioxide
- Zinc Oxide
- Butylene Glycol
- Butylparaben
- Medium-Chain Triglycerides
- Carbomer Copolymer Type B (Allyl Pentaerythritol Crosslinked)
- Cetostearyl Alcohol
- Cetearyl Glucoside
- Cyclomethicone
- Dimethicone
- Edetate Trisodium
- Glyceryl Monostearate
- Ferric Oxide Yellow
- Ferrosoferric Oxide
- Isobutylparaben
- Isopropylparaben
- Melissa Officinalis Leaf
- Octyldodecyl Neopentanoate
- PEG-100 Stearate
- Phenoxyethanol
- Vitamin A Palmitate
- Sorbitan Monolaurate
- Talc
- Tocopherol
- .Alpha.-Tocopherol Acetate
- Tricontanyl Povidone (4 Tricontanyl Branches/Repeat)
- Water
- Xanthan Gum
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 58892-070 | 58892-070-58 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| Glyceryl Monostearate | GLYCERYL MONOSTEARATE | 230OU9XXE4 | TABLET / SUBLINGUAL | 1.23 mg | ||
| Xanthan Gum | XANTHAN GUM | TTV12P4NEE | SUSPENSION / RECTAL | 452 mg | ||
| Ferric Oxide Yellow | FERRIC OXIDE YELLOW | EX438O2MRT | TABLET, FILM COATED / ORAL | 6 mg | ||
| Talc | TALC | 7SEV7J4R1U | CAPSULE, COATED, EXTENDED RELEASE / ORAL | 20 mg | ||
| Ferric Oxide Yellow | FERRIC OXIDE YELLOW | EX438O2MRT | POWDER / RESPIRATORY (INHALATION) | 0.04 mg | ||
| Carbomer Copolymer Type B (Allyl Pentaerythritol Crosslinked) | CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) | 809Y72KV36 | GEL / TOPICAL | 150 mg | ||
| Talc | TALC | 7SEV7J4R1U | GRANULE, DELAYED RELEASE / ORAL | 525 mg | ||
| Tocopherol | TOCOPHEROL | R0ZB2556P8 | CAPSULE, COATED / ORAL | 0.25 mg | ||
| Xanthan Gum | XANTHAN GUM | TTV12P4NEE | SUSPENSION / TOPICAL | 0.11 %w/v | ||
| Xanthan Gum | XANTHAN GUM | TTV12P4NEE | FILM, SOLUBLE / ORAL | 1 mg | ||
| Glyceryl Monostearate | GLYCERYL MONOSTEARATE | 230OU9XXE4 | LOTION / TOPICAL | 177 mg | ||
| Talc | TALC | 7SEV7J4R1U | CAPSULE, COATED / ORAL | 87 mg | ||
| Medium-Chain Triglycerides | MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | AEROSOL, FOAM / TOPICAL | 10.87 %w/w | ||
| Glyceryl Monostearate | GLYCERYL MONOSTEARATE | 230OU9XXE4 | AEROSOL, FOAM / TOPICAL | 3.27 %w/w | ||
| Butylene Glycol | BUTYLENE GLYCOL | 3XUS85K0RA | SYSTEM / TOPICAL | 1400 mg | ||
| Medium-Chain Triglycerides | MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | INJECTION, SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS | 990.3 mg | ||
| Talc | TALC | 7SEV7J4R1U | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 60 mg | ||
| PEG-100 Stearate | PEG-100 MONOSTEARATE | YD01N1999R | LOTION / TOPICAL | 1 %w/w | ||
| Medium-Chain Triglycerides | MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | OINTMENT / TOPICAL | 20 %w/w | ||
| Butylene Glycol | BUTYLENE GLYCOL | 3XUS85K0RA | SYSTEM / TRANSDERMAL | 8.12 mg | ||
| Xanthan Gum | XANTHAN GUM | TTV12P4NEE | TABLET / ORAL | 56 mg | ||
| Ferric Oxide Yellow | FERRIC OXIDE YELLOW | EX438O2MRT | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| Butylparaben | BUTYLPARABEN | 3QPI1U3FV8 | CAPSULE / ORAL | NA | ||
| Talc | TALC | 7SEV7J4R1U | PELLET / ORAL | 69 mg | ||
| Talc | TALC | 7SEV7J4R1U | TABLET, FOR SUSPENSION / ORAL | 24 mg | ||
| Ferric Oxide Yellow | FERRIC OXIDE YELLOW | EX438O2MRT | TABLET, DELAYED RELEASE / ORAL | 7 mg | ||
| Butylparaben | BUTYLPARABEN | 3QPI1U3FV8 | SUSPENSION / ORAL | 12 mg | ||
| Ferrosoferric Oxide | FERROSOFERRIC OXIDE | XM0M87F357 | TABLET, DELAYED RELEASE / ORAL | 6 mg | ||
| Glyceryl Monostearate | GLYCERYL MONOSTEARATE | 230OU9XXE4 | CAPSULE, EXTENDED RELEASE / ORAL | 32.4 mg | ||
| Butylparaben | BUTYLPARABEN | 3QPI1U3FV8 | OINTMENT / TOPICAL | 0.18 %w/w | ||
| Talc | TALC | 7SEV7J4R1U | POWDER / TOPICAL | 9235 mg | ||
| Carbomer Copolymer Type B (Allyl Pentaerythritol Crosslinked) | CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) | 809Y72KV36 | GEL / TRANSDERMAL | 30 mg | ||
| Talc | TALC | 7SEV7J4R1U | ELIXIR / ORAL | 4.5 mg/5ml | ||
| Talc | TALC | 7SEV7J4R1U | TABLET, CHEWABLE / ORAL | 202 mg | ||
| Talc | TALC | 7SEV7J4R1U | CAPSULE, COATED PELLETS / ORAL | 14 mg | ||
| .Alpha.-Tocopherol Acetate | .ALPHA.-TOCOPHEROL ACETATE | 9E8X80D2L0 | TABLET / ORAL | 0.5 mg | ||
| Xanthan Gum | XANTHAN GUM | TTV12P4NEE | ENEMA / RECTAL | 150 mg | ||
| Phenoxyethanol | PHENOXYETHANOL | HIE492ZZ3T | AEROSOL / TOPICAL | 1.05 %w/w | ||
| Phenoxyethanol | PHENOXYETHANOL | HIE492ZZ3T | AEROSOL, FOAM / TOPICAL | 72 mg | ||
| Carbomer Copolymer Type B (Allyl Pentaerythritol Crosslinked) | CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) | 809Y72KV36 | EMULSION / OPHTHALMIC | 0.05 %w/w | ||
| Xanthan Gum | XANTHAN GUM | TTV12P4NEE | TABLET, EXTENDED RELEASE / ORAL | 528 mg | ||
| Xanthan Gum | XANTHAN GUM | TTV12P4NEE | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 36 mg | ||
| Medium-Chain Triglycerides | MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | CAPSULE / ORAL | 4771 mg | ||
| Xanthan Gum | XANTHAN GUM | TTV12P4NEE | SUSPENSION, EXTENDED RELEASE / ORAL | 186.8 mg | ||
| .Alpha.-Tocopherol Acetate | .ALPHA.-TOCOPHEROL ACETATE | 9E8X80D2L0 | FILM / BUCCAL | 0.09 mg | ||
| Sorbitan Monolaurate | SORBITAN MONOLAURATE | 6W9PS8B71J | TABLET / ORAL | 800 mg | ||
| Xanthan Gum | XANTHAN GUM | TTV12P4NEE | TABLET, ORALLY DISINTEGRATING / ORAL | 0.15 mg | ||
| Cyclomethicone | CYCLOMETHICONE | NMQ347994Z | LOTION / TOPICAL | 3510 mg | ||
| Ferrosoferric Oxide | FERROSOFERRIC OXIDE | XM0M87F357 | POWDER, FOR SUSPENSION / ORAL | NA | ||
| Ferrosoferric Oxide | FERROSOFERRIC OXIDE | XM0M87F357 | TABLET / ORAL | 2 mg | ||
| Tocopherol | TOCOPHEROL | R0ZB2556P8 | CAPSULE / ORAL | NA | ||
| Carbomer Copolymer Type B (Allyl Pentaerythritol Crosslinked) | CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) | 809Y72KV36 | LOTION / TOPICAL | 29 mg | ||
| Cetostearyl Alcohol | CETOSTEARYL ALCOHOL | 2DMT128M1S | TABLET, EXTENDED RELEASE / ORAL | 800 mg | ||
| Carbomer Copolymer Type B (Allyl Pentaerythritol Crosslinked) | CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) | 809Y72KV36 | FILM, EXTENDED RELEASE / TRANSDERMAL | 38.9 mg | ||
| Talc | TALC | 7SEV7J4R1U | OINTMENT / TOPICAL | 74.6 %w/w | ||
| Sorbitan Monolaurate | SORBITAN MONOLAURATE | 6W9PS8B71J | SPRAY, METERED / NASAL | 1 mg | ||
| Medium-Chain Triglycerides | MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | SOLUTION / ORAL | 5566 mg | ||
| Medium-Chain Triglycerides | MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | SUSPENSION / ORAL | 10170 mg | ||
| Xanthan Gum | XANTHAN GUM | TTV12P4NEE | SOLUTION / ORAL | 84 mg | ||
| Glyceryl Monostearate | GLYCERYL MONOSTEARATE | 230OU9XXE4 | LIQUID / TOPICAL | 1 %w/w |
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 |
|---|---|---|---|---|---|---|
| ef82223e-f4df-4917-baae-d305ad052fb6 | 649dbe58-a0a1-494a-a1d7-9c6f3cd83bc6 | 2013-01-02 | Warnings | ef82223e-f4df-4917-baae-d305ad052fb6 649dbe58-a0a1-494a-a1d7-9c6f3cd83bc6 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.