Indications and uses
* Helps prevent sunburn * Higher SPF gives more sunburn protection. * Provides moderate protection against sunburn
CYZONE
- Manufacturer
- Ventura Corporation Ltd. | Bel Star, S. A.(Colombia) | Yobel Supply Chain Management (Peru)
- Effective date
- 2011-11-29
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 01:50:11
Label at a glance#
ProductCYZONE CY Cover Mat
Active ingredientOctinoxate, Titanium Dioxide
Label structure12 sections
Dosage and administration
* Apply generously and evently before sun exposure and as needed
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
Active Ingredients
OCTINOXATE 6.0 %, TITANIUM DIOXIDE 0.8 %
Purpose
sunscreen
Uses
- Helps prevent sunburn
- Higher SPF gives more sunburn protection.
- Provides moderate protection against sunburn
Warnings
For external only.
OTC - WHEN USING SECTION
When using this product keep out of eyes. Rinse with water to remove.
OTC - STOP USE SECTION
Stop use and ask a doctor if rash or irritation develops and lasts
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 generously and evently before sun exposure and as needed
Inactive ingredients
WATER, CYCLOPENTASILOXANE, SILICA, CYCLOHEXASILOXANE, CETYL PEG/PPG-10/1 DIMETHICONE, POLYGLYCERYL-4 ISOSTEARATE, HEXYL LAURATE, TRIMETHYLSILOXYSILICATE, GLYCERIN, SODIUM CHLORIDE, DISTEARDIMONIUM HECTORITE, BAMBUSA ARUNDINACEA STEM POWDER, PEG/PPG-19/19 DIMETHICONE, DIAZOLIDINYL UREA, METHYLPARABEN, PROPYLENE CARBONATE, PROPYLPARABEN, SILICA DIMETHYL SILYLATE, LYCOPODIUM CLAVATUM EXINE, TOCOPHERYL ACETATE, ALUMINA, TRIETHOXYCAPRYLYLSILANE, BHA, BHT, IMPERATA CYLINDRICA ROOT EXTRACT, METHICONE. MAY CONTAIN: CI 77492 (IRON OXIDES), CI 77491 (IRON OXIDES), CI 77499 (IRON OXIDES))
SPL UNCLASSIFIED SECTION
P.R.:Dist. by Ventura Corporation, Ltd., San Juan, Puerto Rico 00926. Made in Colombia.
PRINCIPAL DISPLAY PANEL - 27 g Tube Label
cover mat
cy°
cy°zone
27 g e (.95 oz.)
PRINCIPAL DISPLAY PANEL - 27 g Tube Label
cover mat
cy°
cy°zone
27 g e (.95 oz.)
PRINCIPAL DISPLAY PANEL - 27 g Tube Label
cover mat
cy°
cy°zone
27 g e (.95 oz.)
PRINCIPAL DISPLAY PANEL - 27 g Tube Label
cover mat
cy°
cy°zone
27 g e (.95 oz.)
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 13537-123-01 | 2025-04-04 | C162847 | 48780-1 | 97449f38-b570-f6ea-e053-dbdaa90aa703 | cy°zone cover mat |
| 13537-124-01 | 2025-04-04 | C162847 | 48780-1 | 97449f38-b570-f6ea-e053-dbdaa90aa703 | cy°zone cover mat |
| 13537-125-01 | 2025-04-04 | C162847 | 48780-1 | 97449f38-b570-f6ea-e053-dbdaa90aa703 | cy°zone cover mat |
| 13537-126-01 | 2025-04-04 | C162847 | 48780-1 | 97449f38-b570-f6ea-e053-dbdaa90aa703 | cy°zone cover mat |
| 13537-123-01 | 2019-11-13 | C162847 | 48780-1 | 97449f38-b570-f6ea-e053-dbdaa90aa703 | cy°zone cover mat |
| 13537-124-01 | 2019-11-13 | C162847 | 48780-1 | 97449f38-b570-f6ea-e053-dbdaa90aa703 | cy°zone cover mat |
| 13537-125-01 | 2019-11-13 | C162847 | 48780-1 | 97449f38-b570-f6ea-e053-dbdaa90aa703 | cy°zone cover mat |
| 13537-126-01 | 2019-11-13 | C162847 | 48780-1 | 97449f38-b570-f6ea-e053-dbdaa90aa703 | cy°zone cover mat |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Octinoxate | ACTIVE INGREDIENT | 4Y5P7MUD51 | 1 | |
| Titanium Dioxide | ACTIVE INGREDIENT | 15FIX9V2JP | 1 | |
| Octinoxate | ACTIVE MOIETY | 4Y5P7MUD51 | 1 | |
| Titanium Dioxide | ACTIVE MOIETY | 15FIX9V2JP | 1 | |
| ALPHA-TOCOPHEROL ACETATE | INACTIVE INGREDIENT | 9E8X80D2L0 | 1 | |
| ALUMINUM OXIDE | INACTIVE INGREDIENT | LMI26O6933 | 1 | |
| BAMBUSA ARUNDINACEA STEM | INACTIVE INGREDIENT | NRA4497HC5 | 1 | |
| BUTYLATED HYDROXYANISOLE | INACTIVE INGREDIENT | REK4960K2U | 1 | |
| BUTYLATED HYDROXYTOLUENE | INACTIVE INGREDIENT | 1P9D0Z171K | 1 | |
| CYCLOMETHICONE 5 | INACTIVE INGREDIENT | 0THT5PCI0R | 1 | |
| CYCLOMETHICONE 6 | INACTIVE INGREDIENT | XHK3U310BA | 1 | |
| DIAZOLIDINYL UREA | INACTIVE INGREDIENT | H5RIZ3MPW4 | 1 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | 1 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | 1 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | 1 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| HEXYL LAURATE | INACTIVE INGREDIENT | 4CG9F9W01Q | 1 | |
| IMPERATA CYLINDRICA ROOT | INACTIVE INGREDIENT | VYT2JA85NH | 1 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | 1 | |
| POLYGLYCERYL-4 ISOSTEARATE | INACTIVE INGREDIENT | 820DPX33S7 | 1 | |
| PROPYLENE CARBONATE | INACTIVE INGREDIENT | 8D08K3S51E | 1 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | 1 | |
| SILICA DIMETHYL SILYLATE | INACTIVE INGREDIENT | EU2PSP0G0W | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 1 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | 1 | |
| TRIETHOXYCAPRYLYLSILANE | INACTIVE INGREDIENT | LDC331P08E | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Products#
Every source-derived product name is available through these pages.
- CYZONE CY Cover Mat
- Octinoxate and Titanium Dioxide
- Octinoxate
- Titanium Dioxide
- WATER
- CYCLOMETHICONE 5
- SILICON DIOXIDE
- CYCLOMETHICONE 6
- POLYGLYCERYL-4 ISOSTEARATE
- HEXYL LAURATE
- GLYCERIN
- SODIUM CHLORIDE
- BAMBUSA ARUNDINACEA STEM
- DIAZOLIDINYL UREA
- METHYLPARABEN
- PROPYLENE CARBONATE
- PROPYLPARABEN
- SILICA DIMETHYL SILYLATE
- ALPHA-TOCOPHEROL ACETATE
- ALUMINUM OXIDE
- TRIETHOXYCAPRYLYLSILANE
- BUTYLATED HYDROXYANISOLE
- BUTYLATED HYDROXYTOLUENE
- IMPERATA CYLINDRICA ROOT
- FERRIC OXIDE YELLOW
- FERRIC OXIDE RED
- FERROSOFERRIC OXIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 13537-123 | 13537-123-01 |
| 13537-124 | 13537-124-01 |
| 13537-125 | 13537-125-01 |
| 13537-126 | 13537-126-01 |
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 |
|---|---|---|---|---|---|---|
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SOLUTION / RESPIRATORY (INHALATION) | 108 mg | ||
| DIAZOLIDINYL UREA | DIAZOLIDINYL UREA | H5RIZ3MPW4 | LOTION / TOPICAL | 3 %w/w | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | LOZENGE / ORAL | 120 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | DROPS / NASAL | 14 mg | ||
| BUTYLATED HYDROXYANISOLE | BUTYLATED HYDROXYANISOLE | REK4960K2U | TABLET / ORAL | 8 mg | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | AEROSOL, FOAM / TOPICAL | 4 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION / ORAL | 26208 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | LIQUID / ORAL | 162 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SHAMPOO / TOPICAL | 5 %w/w | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | DROPS / ORAL | NA | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | AEROSOL / TOPICAL | 3 %w/w | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SOLUTION / INTRA-ARTERIAL | 278 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | SYSTEM / TRANSDERMAL | 35 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION, SOLUTION / INTRAMUSCULAR | 15 %w/v | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | TABLET, COATED / ORAL | 0.8 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | CREAM / TOPICAL | 6 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SHAMPOO, SUSPENSION / TOPICAL | 0.15 %w/w | ||
| BUTYLATED HYDROXYANISOLE | BUTYLATED HYDROXYANISOLE | REK4960K2U | TABLET, ORALLY DISINTEGRATING / ORAL | 2 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / INTRAVITREAL | 10 %w/v | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | INJECTION / INTRA-ARTICULAR | 0.03 %w/v | ||
| FERROSOFERRIC OXIDE | FERROSOFERRIC OXIDE | XM0M87F357 | TABLET, EXTENDED RELEASE / ORAL | 8 mg | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | INJECTION, SOLUTION / INTRAVENOUS | NA | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SUSPENSION/ DROPS / OPHTHALMIC | 3 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | SUSPENSION, EXTENDED RELEASE / ORAL | 70 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION / INTRADERMAL | 1.6 %w/v | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / INTRA-ARTICULAR | 0.24 %w/v | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | DROPS / ORAL | 1 mg/1ml | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE, FOR SUSPENSION / ORAL | 200 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SUSPENSION / ORAL | 1126 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | PASTE, DENTIFRICE / DENTAL | 0.05 %w/w | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | POWDER / ORAL | 602 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SOLUTION / IRRIGATION | 2 %w/v | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | TABLET / ORAL | 0.2 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CREAM / VAGINAL | 60 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | EMULSION / OPHTHALMIC | 3 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | CAPSULE, EXTENDED RELEASE / ORAL | 41 mg | ||
| BUTYLATED HYDROXYANISOLE | BUTYLATED HYDROXYANISOLE | REK4960K2U | INJECTION, SOLUTION / INTRAVENOUS | NA | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | GRANULE, FOR SUSPENSION / ORAL | 162 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | INJECTION, SOLUTION / INTRAMUSCULAR | 5 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | ENEMA / RECTAL | 0.7 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | PASTE / DENTAL | 20 %w/w | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SUSPENSION / TOPICAL | 0.32 %w/v | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SUSPENSION / ORAL | 388 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / INFILTRATION | 648 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SOLUTION, CONCENTRATE / INTRAMUSCULAR | 0.86 %w/v | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / INTRAVASCULAR | 0.86 %w/v | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | ENEMA / RECTAL | 0.02 %w/w | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET, COATED / ORAL | 1 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SOLUTION / SUBARACHNOID | 0.9 %w/v | ||
| ALPHA-TOCOPHEROL ACETATE | .ALPHA.-TOCOPHEROL ACETATE | 9E8X80D2L0 | TABLET / ORAL | 0.5 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SOLUTION / AURICULAR (OTIC) | 18 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SOLUTION / INTRAVASCULAR | NA | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SUSPENSION, EXTENDED RELEASE / ORAL | 40 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET, EXTENDED RELEASE / ORAL | 7 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / NASAL | 25 mg/1ml | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SPRAY, METERED / NASAL | 36 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SYSTEM / IONTOPHORESIS | 3.1 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / EPIDURAL | 1 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | FILM, EXTENDED RELEASE / TRANSDERMAL | 49 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SYRUP / ORAL | 81 mg |
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 |
|---|---|---|---|---|---|---|
| 31f67282-5d37-ad2d-e063-6294a90a9431 | 66979c60-e0a4-4ca0-979b-237873b9ca1b | 2025-04-04 | Warnings | 66979c60-e0a4-4ca0-979b-237873b9ca1b |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.