Indications and uses
Helps prevent sunburn
CYZONE
- Manufacturer
- Ventura Corporation LTD. | Bel Star S.A. (Colombia) | Yobel Supply Chain Management S.A. (Peru)
- Effective date
- 2012-07-14
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 01:46:42
Label at a glance#
ProductCYZONE CY PERLIPS Labial Hidratante con perlas de luz y FPS 20
Active ingredientOctinoxate, Oxybenzone
Label structure10 sections
Dosage and administration
Apply liberally and evenly 15 minutes before sun exposure. Children under 6 months of age: Ask a doctor. Reapply at least every 2 hours. Use a water resistant sunscreen if swimming or sweating.
Storage and handling
Protect the product in this container from excessive heat and direct sun.
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
Active Ingredients
OCTINOXATE 7.0 % , OXYBENZONE 2.5 %
Purpose
Sunscreen
Uses
- Helps prevent sunburn
Warnings
SPL UNCLASSIFIED SECTION
- Skin Cancer / Skin Aging Alert; Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.
- For external use only.
OTC - DO NOT USE SECTION
- Do not use on damage or broken skin.
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 occurs.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
- Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- Apply liberally and evenly 15 minutes before sun exposure.
- Children under 6 months of age: Ask a doctor.
- Reapply at least every 2 hours.
- Use a water resistant sunscreen if swimming or sweating.
Other information
- Protect the product in this container from excessive heat and direct sun.
Inactive ingredients
RICINUS COMMUNIS SEED OIL (RICINUS COMMUNIS (CASTOR) SEED OIL), CAPRYLIC/CAPRIC TRIGLYCERIDE, POLYETHYLENE, CERA ALBA (BEESWAX), CANDELILLA CERA (EUPHORBIA CERIFERA (CANDELILLA) WAX), HYDROGENATED VEGETABLE OIL, BUTYROSPERMUM PARKII BUTTER (BUTYROSPERMUM PARKII (SHEA) BUTTER), SILICA DIMETHYL SILYLATE, GLYCERIN, OCTYLDODECANOL, PARFUM (FRAGRANCE), GLYCERYL ISOSTEARATE, ISOSTEARYL ALCOHOL, HELIANTHUS ANNUUS SEED OIL (HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL), SODIUM SACCHARIN, PROPYLPARABEN, MICROCRISTALLINA CERA (MICROCRYSTALLINE WAX), BETA-SITOSTEROL, PETROLATUM, BHT, TOCOPHERYL ACETATE, PHOSPHOLIPIDS, CHOLESTEROL, CETEARYL ALCOHOL, CETEARYL GLUCOSIDE, COPERNICIA CERIFERA CERA (COPERNICIA CERIFERA (CARNAUBA ) WAX), POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE, GLYCOSPHINGOLIPIDS. May contain:: CI 77742 (MANGANESE VIOLET), CI 15850 (RED 7 LAKE), CI 77492 (IRON OXIDES), CI 77891 (TITANIUM DIOXIDE ), SYNTHETIC FLUORPHLOGOPITE, CI 19140 (YELLOW 5 LAKE), CI 73360 (RED 30).
SPL UNCLASSIFIED SECTION
Distributed by Ventura Corporation, Ltd., San Juan, Puerto Rico 00926.
PRINCIPAL DISPLAY PANEL - 4 g Stick Label
perlips
labial hidratante con
perlas de luz y FPS 20
cy°
cy°zone
4 g e (.14 oz.)
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 13537-432-01 | 2025-04-24 | C162847 | 48780-1 | 97449f38-d3b8-f6ea-e053-dbdaa90aa703 | CYZONE CY PERLIPS Labial Hidratante con perlas de luz y FPS 20 |
| 13537-432-01 | 2019-11-13 | C162847 | 48780-1 | 97449f38-d3b8-f6ea-e053-dbdaa90aa703 | CYZONE CY PERLIPS Labial Hidratante con perlas de luz y FPS 20 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Octinoxate | ACTIVE INGREDIENT | 4Y5P7MUD51 | 1 | |
| Oxybenzone | ACTIVE INGREDIENT | 95OOS7VE0Y | 1 | |
| Octinoxate | ACTIVE MOIETY | 4Y5P7MUD51 | 1 | |
| Oxybenzone | ACTIVE MOIETY | 95OOS7VE0Y | 1 | |
| .ALPHA.-TOCOPHEROL ACETATE | INACTIVE INGREDIENT | 9E8X80D2L0 | 1 | |
| .BETA.-SITOSTEROL | INACTIVE INGREDIENT | S347WMO6M4 | 1 | |
| ALUMINUM OXIDE | INACTIVE INGREDIENT | LMI26O6933 | 1 | |
| BUTYLATED HYDROXYTOLUENE | INACTIVE INGREDIENT | 1P9D0Z171K | 1 | |
| CANDELILLA WAX | INACTIVE INGREDIENT | WL0328HX19 | 1 | |
| CARNAUBA WAX | INACTIVE INGREDIENT | R12CBM0EIZ | 1 | |
| CASTOR OIL | INACTIVE INGREDIENT | D5340Y2I9G | 1 | |
| CETEARYL GLUCOSIDE | INACTIVE INGREDIENT | 09FUA47KNA | 1 | |
| CETOSTEARYL ALCOHOL | INACTIVE INGREDIENT | 2DMT128M1S | 1 | |
| CHOLESTEROL | INACTIVE INGREDIENT | 97C5T2UQ7J | 1 | |
| D&C RED NO. 30 | INACTIVE INGREDIENT | 2S42T2808B | 1 | |
| D&C RED NO. 7 | INACTIVE INGREDIENT | ECW0LZ41X8 | 1 | |
| FD&C YELLOW NO. 5 | INACTIVE INGREDIENT | I753WB2F1M | 1 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | 1 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| GLYCERYL ISOSTEARATE | INACTIVE INGREDIENT | HYE7O27HAO | 1 | |
| HIGH DENSITY POLYETHYLENE | INACTIVE INGREDIENT | UG00KM4WR7 | 1 | |
| ISOSTEARYL ALCOHOL | INACTIVE INGREDIENT | Q613OCQ44Y | 1 | |
| MANGANESE VIOLET | INACTIVE INGREDIENT | 72M48QQV8Q | 1 | |
| MEDIUM-CHAIN TRIGLYCERIDES | INACTIVE INGREDIENT | C9H2L21V7U | 1 | |
| MICROCRYSTALLINE WAX | INACTIVE INGREDIENT | XOF597Q3KY | 1 | |
| OCTYLDODECANOL | INACTIVE INGREDIENT | 461N1O614Y | 1 | |
| PETROLATUM | INACTIVE INGREDIENT | 4T6H12BN9U | 1 | |
| POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE | INACTIVE INGREDIENT | 9229XJ4V12 | 1 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | 1 | |
| SACCHARIN SODIUM DIHYDRATE | INACTIVE INGREDIENT | SB8ZUX40TY | 1 | |
| SHEA BUTTER | INACTIVE INGREDIENT | K49155WL9Y | 1 | |
| SILICA DIMETHYL SILYLATE | INACTIVE INGREDIENT | EU2PSP0G0W | 1 | |
| SUNFLOWER OIL | INACTIVE INGREDIENT | 3W1JG795YI | 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 PERLIPS Labial Hidratante con perlas de luz y FPS 20
- Octinoxate and Oxybenzone
- Octinoxate
- Oxybenzone
- CASTOR OIL
- MEDIUM-CHAIN TRIGLYCERIDES
- HIGH DENSITY POLYETHYLENE
- YELLOW WAX
- CANDELILLA WAX
- SHEA BUTTER
- SILICA DIMETHYL SILYLATE
- GLYCERIN
- OCTYLDODECANOL
- GLYCERYL ISOSTEARATE
- ISOSTEARYL ALCOHOL
- SUNFLOWER OIL
- SACCHARIN SODIUM DIHYDRATE
- PROPYLPARABEN
- MICROCRYSTALLINE WAX
- .BETA.-SITOSTEROL
- PETROLATUM
- BUTYLATED HYDROXYTOLUENE
- .ALPHA.-TOCOPHEROL ACETATE
- CHOLESTEROL
- CETOSTEARYL ALCOHOL
- CETEARYL GLUCOSIDE
- CARNAUBA WAX
- POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE
- MANGANESE VIOLET
- D&C RED NO. 7
- ALUMINUM OXIDE
- FERRIC OXIDE YELLOW
- TITANIUM DIOXIDE
- FD&C YELLOW NO. 5
- D&C RED NO. 30
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 13537-432 | 13537-432-01 |
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 |
|---|---|---|---|---|---|---|
| YELLOW WAX | YELLOW WAX | 2ZA36H0S2V | TABLET, SUGAR COATED / ORAL | NA | ||
| OCTYLDODECANOL | OCTYLDODECANOL | 461N1O614Y | SUPPOSITORY / VAGINAL | NA | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CAPSULE, EXTENDED RELEASE / ORAL | 265 mg | ||
| CETOSTEARYL ALCOHOL | CETOSTEARYL ALCOHOL | 2DMT128M1S | TABLET, EXTENDED RELEASE / ORAL | 800 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | GRANULE, FOR SUSPENSION / ORAL | 11 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SUSPENSION / AURICULAR (OTIC) | NA | ||
| D&C RED NO. 7 | D&C RED NO. 7 | ECW0LZ41X8 | CAPSULE, DELAYED RELEASE / ORAL | NA | ||
| YELLOW WAX | YELLOW WAX | 2ZA36H0S2V | CREAM / TOPICAL | 5 %w/w | ||
| GLYCERYL ISOSTEARATE | GLYCERYL ISOSTEARATE | HYE7O27HAO | CREAM / VAGINAL | 135 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | GEL / VAGINAL | 2 mg | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | CAPSULE, EXTENDED RELEASE / ORAL | 0.03 mg | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | TABLET / ORAL | 167.8 mg | ||
| CHOLESTEROL | CHOLESTEROL | 97C5T2UQ7J | INJECTABLE, LIPOSOMAL / INFILTRATION | 0.47 %w/v | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | SUPPOSITORY / VAGINAL | NA | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | CAPSULE, EXTENDED RELEASE / ORAL | 0.07 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION / INTRADERMAL | 1.6 %w/v | ||
| MICROCRYSTALLINE WAX | MICROCRYSTALLINE WAX | XOF597Q3KY | GEL / TOPICAL | NA | ||
| OCTYLDODECANOL | OCTYLDODECANOL | 461N1O614Y | CREAM / VAGINAL | 13.5 %w/w | ||
| SILICA DIMETHYL SILYLATE | SILICA DIMETHYL SILYLATE | EU2PSP0G0W | TABLET, EXTENDED RELEASE / ORAL | 10 mg | ||
| CASTOR OIL | CASTOR OIL | D5340Y2I9G | TABLET / SUBLINGUAL | 1.6 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | TABLET, EXTENDED RELEASE / ORAL | 15 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | EMULSION / INTRAVENOUS | 2.2 %w/v | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | FILM, SOLUBLE / ORAL | 0.06 mg | ||
| HIGH DENSITY POLYETHYLENE | HIGH DENSITY POLYETHYLENE | UG00KM4WR7 | FILM, EXTENDED RELEASE / TRANSDERMAL | 85 mg | ||
| CASTOR OIL | CASTOR OIL | D5340Y2I9G | TABLET, EXTENDED RELEASE / ORAL | 23.27 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | AEROSOL, FOAM / TOPICAL | 0.04 %w/w | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | LOTION / TOPICAL | NA | ||
| SACCHARIN SODIUM DIHYDRATE | SACCHARIN SODIUM | SB8ZUX40TY | OINTMENT / DENTAL | NA | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION, SOLUTION / SUBCUTANEOUS | 15 %w/v | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | FILM / BUCCAL | 3 mg | ||
| CANDELILLA WAX | CANDELILLA WAX | WL0328HX19 | TABLET, EXTENDED RELEASE / ORAL | 3 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | SUPPOSITORY / VAGINAL | 27 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | LIQUID / RESPIRATORY (INHALATION) | NA | ||
| MEDIUM-CHAIN TRIGLYCERIDES | MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | TABLET, ORALLY DISINTEGRATING / ORAL | 1 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | SOAP / TOPICAL | 1 %w/w | ||
| SACCHARIN SODIUM DIHYDRATE | SACCHARIN SODIUM | SB8ZUX40TY | FILM, SOLUBLE / BUCCAL | 2 mg | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | TABLET, DELAYED RELEASE / ORAL | 230 mg | ||
| MICROCRYSTALLINE WAX | MICROCRYSTALLINE WAX | XOF597Q3KY | OINTMENT / TOPICAL | 3575 mg | ||
| MEDIUM-CHAIN TRIGLYCERIDES | MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | GEL / TOPICAL | 12 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | LOTION / TOPICAL | 3990 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CONCENTRATE / ORAL | 1800 mg | ||
| SILICA DIMETHYL SILYLATE | SILICA DIMETHYL SILYLATE | EU2PSP0G0W | CREAM / VAGINAL | 50 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | MOUTHWASH / BUCCAL | 100 mg/1ml | ||
| CASTOR OIL | CASTOR OIL | D5340Y2I9G | EMULSION / OPHTHALMIC | 32 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION, EXTENDED RELEASE / ORAL | 2000 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | CREAM / TOPICAL | 4213 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | PASTE, DENTIFRICE / DENTAL | NA | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | AEROSOL / TOPICAL | 3 %w/w | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | TABLET, CHEWABLE / ORAL | 0.14 mg | ||
| HIGH DENSITY POLYETHYLENE | HIGH DENSITY POLYETHYLENE | UG00KM4WR7 | SYSTEM / TRANSDERMAL | NA | ||
| CASTOR OIL | CASTOR OIL | D5340Y2I9G | OINTMENT / TOPICAL | 14.9 %w/w | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 140 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | FILM, SOLUBLE / BUCCAL | 1 mg | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | GUM, CHEWING / BUCCAL | 10 mg | ||
| CETOSTEARYL ALCOHOL | CETOSTEARYL ALCOHOL | 2DMT128M1S | SUPPOSITORY / VAGINAL | NA | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | OINTMENT / TOPICAL | 57 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | JELLY / VAGINAL | NA | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | INJECTION, SOLUTION / INTRAVENOUS | NA | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | NA | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 225 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 |
|---|---|---|---|---|---|---|
| 338b6895-7886-8842-e063-6394a90aabf6 | 1c4b5faa-1a80-465b-9e4b-211ffecfd701 | 2025-04-24 | Warnings | 1c4b5faa-1a80-465b-9e4b-211ffecfd701 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.