Indications and uses
Helps prevent sunburn.
CYZONE
- Manufacturer
- Ventura Corporation Limited | BelStar, S.A.
- Effective date
- 2010-11-10
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 01:51:52
Label at a glance#
ProductCYZONE CY
Active ingredientOCTINOXATE, OCTOCRYLENE
Label structure10 sections
Label contents#
Full prescribing information#
Active Ingredients
Octinoxate: 6.0%, Octocrylene: 4,0%.
Purpose
Sunscreen.
Uses
Helps prevent sunburn.
Warnings
OTC - STOP USE SECTION
Stop use if skin rash occurs.
Ingredients
Diisopropyl dimer dilinoleate, petrolatum, polybutene, butyrospermum parkii (butyrospermum parkii (shea butter)), cera alba (beeswax), silica, cera microcristallina (microcrystalline wax), parfum (fragrance), silica dimethyl silylate, bht, caprylic/capric triglyceride, diethylhexyl syringylidene malonate, glycerin, methylparaben, ozokerite, propylparaben, sodium saccharin, theobroma cacao seed butter (theobroma cacao (cocoa) seed butter), tocopheryl acetate. May contain: CI 77019 (mica), CI 45380 (red 21 lake), CI 77891 (titanium dioxide), CI 15850 (red 7 lake), CI 19140 (yellow 5 lake), CI 42090 (blue 1 lake), CI 45410 (red 27 lake).
SPL UNCLASSIFIED SECTION
P.R.:Dist. by Ventura Corporation, Ltd., San Juan, Puerto Rico 00926. Made in Colombia.
PRINCIPAL DISPLAY PANEL - 14 g CherryLemon Container
humectante para labios con aroma FPS 15
14 g e (.49 oz.)
cy°bulkyz
PRINCIPAL DISPLAY PANEL - 14 g PassionBerry Container
humectante para labios con aroma FPS 15
14 g e (.49 oz.)
cy°bulkyz
PRINCIPAL DISPLAY PANEL - 14 g MintGrape Container
humectante para labios con aroma FPS 15
14 g e (.49 oz.)
cy°bulkyz
PRINCIPAL DISPLAY PANEL - 14 g CocoPine Container
humectante para labios con aroma FPS 15
14 g e (.49 oz.)
cy°bulkyz
FDA-Initiated Inactive NDC Indexing#
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| OCTINOXATE | ACTIVE INGREDIENT | 4Y5P7MUD51 | 1 | |
| OCTOCRYLENE | ACTIVE INGREDIENT | 5A68WGF6WM | 1 | |
| OCTINOXATE | ACTIVE MOIETY | 4Y5P7MUD51 | 1 | |
| OCTOCRYLENE | ACTIVE MOIETY | 5A68WGF6WM | 1 | |
| Aluminum Oxide | INACTIVE INGREDIENT | LMI26O6933 | 1 | |
| BUTYLATED HYDROXYTOLUENE | INACTIVE INGREDIENT | 1P9D0Z171K | 1 | |
| CERESIN | INACTIVE INGREDIENT | Q1LS2UJO3A | 1 | |
| CHOCOLATE | INACTIVE INGREDIENT | D9108TZ9KG | 1 | |
| D&C RED NO. 21 | INACTIVE INGREDIENT | 08744Z6JNY | 1 | |
| D&C RED NO. 27 | INACTIVE INGREDIENT | 2LRS185U6K | 1 | |
| D&C RED NO. 7 | INACTIVE INGREDIENT | ECW0LZ41X8 | 1 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | 1 | |
| FD&C YELLOW NO. 5 | INACTIVE INGREDIENT | I753WB2F1M | 1 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| MEDIUM-CHAIN TRIGLYCERIDES | INACTIVE INGREDIENT | C9H2L21V7U | 1 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | 1 | |
| MICA | INACTIVE INGREDIENT | V8A1AW0880 | 1 | |
| MICROCRYSTALLINE WAX | INACTIVE INGREDIENT | XOF597Q3KY | 1 | |
| PETROLATUM | INACTIVE INGREDIENT | 4T6H12BN9U | 1 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | 1 | |
| SACCHARIN SODIUM | INACTIVE INGREDIENT | SB8ZUX40TY | 1 | |
| SHEA BUTTER | INACTIVE INGREDIENT | K49155WL9Y | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | 1 | |
| YELLOW WAX | INACTIVE INGREDIENT | 2ZA36H0S2V | 1 |
Products#
Every source-derived product name is available through these pages.
- CYZONE CY
- OCTINOXATE and OCTOCRYLENE
- OCTINOXATE
- OCTOCRYLENE
- PETROLATUM
- SHEA BUTTER
- YELLOW WAX
- SILICON DIOXIDE
- MICROCRYSTALLINE WAX
- BUTYLATED HYDROXYTOLUENE
- MEDIUM-CHAIN TRIGLYCERIDES
- GLYCERIN
- METHYLPARABEN
- CERESIN
- PROPYLPARABEN
- SACCHARIN SODIUM
- CHOCOLATE
- MICA
- D&C RED NO. 21
- TITANIUM DIOXIDE
- D&C RED NO. 7
- FD&C YELLOW NO. 5
- FD&C BLUE NO. 1
- D&C RED NO. 27
- Aluminum Oxide
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 13537-012 | 13537-012-14, 13537-012-15 |
| 13537-013 | 13537-013-14, 13537-013-15 |
| 13537-014 | 13537-014-14, 13537-014-15 |
| 13537-015 | 13537-015-14, 13537-015-15 |
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 |
|---|---|---|---|---|---|---|
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, DELAYED RELEASE / ORAL | 1190 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | LIQUID / ORAL | 162 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | SOAP / TOPICAL | 0.85 %w/w | ||
| FD&C YELLOW NO. 5 | FD&C YELLOW NO. 5 | I753WB2F1M | TABLET, SUGAR COATED / ORAL | NA | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SOLUTION, CONCENTRATE / ORAL | 0.2 mg/1ml | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | PASTE / ORAL | 3822 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | OINTMENT / TOPICAL | NA | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | PASTE / DENTAL | 0.5 %w/w | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | TABLET / ORAL | 3 mg | ||
| FD&C YELLOW NO. 5 | FD&C YELLOW NO. 5 | I753WB2F1M | ELIXIR / ORAL | 0.15 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | ELIXIR / ORAL | 800 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | FILM, SOLUBLE / ORAL | 2 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET, DELAYED RELEASE / ORAL | 0.01 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | INJECTION, SOLUTION / INTRAVENOUS | 5 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | DOUCHE / VAGINAL | 1 %w/w | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / PARENTERAL | 18 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION / OPHTHALMIC | 58 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | TABLET, EXTENDED RELEASE / ORAL | 0.18 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | CAPSULE, EXTENDED RELEASE / ORAL | 0.22 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | PASTE / DENTAL | 20 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | EMULSION / INTRAVENOUS | 2.2 %w/v | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | POWDER, FOR SUSPENSION / ORAL | 75 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET / ORAL | 232 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SOLUTION / IRRIGATION | 2 %w/v | ||
| D&C RED NO. 27 | D&C RED NO. 27 | 2LRS185U6K | POWDER, FOR SUSPENSION / ORAL | 1.67 mg/5ml | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE, EXTENDED RELEASE / ORAL | 1 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SUSPENSION, EXTENDED RELEASE / ORAL | 40 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SYRUP / ORAL | 81 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | CAPSULE / ORAL | 1 mg | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | SUPPOSITORY / RECTAL | 1 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION, SUSPENSION / SUBCUTANEOUS | 1.6 %w/v | ||
| D&C RED NO. 7 | D&C RED NO. 7 | ECW0LZ41X8 | CAPSULE, DELAYED RELEASE / ORAL | NA | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | FILM / BUCCAL | 1 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | POWDER, FOR SUSPENSION / ORAL | 8 mg | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | CAPSULE, EXTENDED RELEASE / ORAL | 0.03 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | CONCENTRATE / ORAL | 6 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | CAPSULE / ORAL | 24 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | MOUTHWASH / BUCCAL | NA | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE, DELAYED RELEASE / ORAL | 2 mg | ||
| YELLOW WAX | YELLOW WAX | 2ZA36H0S2V | TABLET, EXTENDED RELEASE / ORAL | 0.01 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, DELAYED RELEASE / ORAL | 40 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / RESPIRATORY (INHALATION) | 5 %w/w | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | FILM, SOLUBLE / ORAL | 0.06 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION, SOLUTION / INTRAMUSCULAR | 15 %w/v | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SPRAY / TOPICAL | 0.2 %w/w | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | POWDER / RESPIRATORY (INHALATION) | NA | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | TABLET, EXTENDED RELEASE / ORAL | 1 mg | ||
| MEDIUM-CHAIN TRIGLYCERIDES | MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | OINTMENT / TOPICAL | 20 %w/w | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, COATED PELLETS / ORAL | 69 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | INJECTION / INFILTRATION | 0.35 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | SUSPENSION / ORAL | 5000 mg/5ml | ||
| FD&C YELLOW NO. 5 | FD&C YELLOW NO. 5 | I753WB2F1M | CAPSULE, EXTENDED RELEASE / ORAL | 0.26 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION / INTRAMUSCULAR | 450 mg | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | LOTION / TOPICAL | 1000 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR | 0.4 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | LOTION / TOPICAL | 25 %w/w | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | GRANULE, FOR SOLUTION / ORAL | 5.5 mg/120ml | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GEL / DENTAL | 19 %w/w | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | GEL / TOPICAL | 8 mg | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | SOAP / TOPICAL | 0.02 %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 |
|---|---|---|---|---|---|---|
| 2e80012c-a615-9d56-e063-6294a90a5e56 | 1f7711ff-ca6c-4891-8eb3-808c8c7d1338 | 2025-02-19 | Warnings | 1f7711ff-ca6c-4891-8eb3-808c8c7d1338 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.