FDA.reportPublic FDA data

CYZONE CY PLAY CREAMY LIP BALM HIDRATANTE EN BARRA PARA LABIOS 24H FPS 12

Manufacturer
BEL STAR S A
Effective date
2025-08-21
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:11:25

Label at a glance#

ProductCYZONE CY PLAY CREAMY LIP BALM HIDRATANTE EN BARRA PARA LABIOS 24H FPS 12 CORAL CREAMY
Active ingredientZINC OXIDE, OCTINOXATE
Label structure14 sections

Indications and uses

Helps prevent sunburn.

Dosage and administration

Apply liberally and evenly 15 minutes before sun exposure. Reapply at least every 2 hours. Use a water resistant sunscreen if swimming or sweating. Children under 6 months of age: Ask a doctor.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 2.50%

Zinc Oxide 3.92%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn.

Warnings

WARNINGS 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.

Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin.

When using this product

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

OTC - STOP USE SECTION

rash occurs.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally and evenly 15 minutes before sun exposure.
  • Reapply at least every 2 hours.
  • Use a water resistant sunscreen if swimming or sweating.
  • Children under 6 months of age: Ask a doctor.

Other information

OTHER SAFETY INFORMATION

  • Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Octyldodecanol, ricinus communis (castor) seed oil, butyrospermum parkii (shea) butter, polyethylene, helianthus annuus (sunflower) seed wax, copernicia cerifera (carnauba) wax, glycerin, dipentaerythrityl hexacaprylate/hexacaprate, vegetable oil, oryza sativa (rice) bran oil, tridecyl trimellitate, olea europaea (olive) oil unsaponifiables, phytosteryl/behenyl/octyldodecyl lauroyl glutamate, oryza sativa (rice) bran wax, rhus succedanea fruit wax, fragrance, tridecyl stearate, disteardimonium hectorite, rhus verniciflua peel wax, shorea robusta resin, neopentyl glycol dicaprylate/dicaprate, phenoxyethanol, cetyl peg/ppg-10/1 dimethicone, polyglyceryl-4 isostearate, lauroyl lysine, hexyl laurate, punica granatum seed oil, prunus avium (sweet cherry) seed oil, pyrus malus (apple) seed oil, vaccinium macrocarpon (cranberry) seed oil, triethoxycaprylylsilane, caprylyl glycol, lecithin, chlorphenesin, water, citrus paradisi (grapefruit) fruit extract, ascorbyl palmitate, tocopherol, citronellol.

May contain:

Mica, titanium dioxide, iron oxides, synthetic fluorphlogopite, red 30 lake, red 7 lake, red 40 lake, talc, red 27 lake, yellow 5 lake, hydrogenated polyisobutene, blue 1 lake, red 21 lake, palmitic acid.

Company Information

SPL UNCLASSIFIED SECTION

PUERTO RICO: Dist. by Ventura Corp, Ltd., San Juan, Puerto Rico 00926. Made in Colombia.

www.cyzone.com

Product Packaging - Fuchsia Creamy

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

Product Packaging - Pink Creamy

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

Product Packaging - Nude Creamy

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

Product Packaging - Coral Creamy

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

Product Packaging - Berry Creamy

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

Product Packaging - Cherry Creamy

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
14141-306-01CYZONE CY PLAY CREAMY LIP BALM HIDRATANTE EN BARRA PARA LABIOS 24H FPS 12 FUCHSIA CREAMY3 g in 1 TUBESTICK34
14141-306-01CYZONE CY PLAY CREAMY LIP BALM HIDRATANTE EN BARRA PARA LABIOS 24H FPS 12 FUCHSIA CREAMY1 in 1 CARTONSTICK14
14141-307-01CYZONE CY PLAY CREAMY LIP BALM HIDRATANTE EN BARRA PARA LABIOS 24H FPS 12 PINK CREAMY1 in 1 CARTONSTICK14
14141-307-01CYZONE CY PLAY CREAMY LIP BALM HIDRATANTE EN BARRA PARA LABIOS 24H FPS 12 PINK CREAMY3 g in 1 TUBESTICK34
14141-308-01CYZONE CY PLAY CREAMY LIP BALM HIDRATANTE EN BARRA PARA LABIOS 24H FPS 12 NUDE CREAMY1 in 1 CARTONSTICK14
14141-308-01CYZONE CY PLAY CREAMY LIP BALM HIDRATANTE EN BARRA PARA LABIOS 24H FPS 12 NUDE CREAMY3 g in 1 TUBESTICK34
14141-309-01CYZONE CY PLAY CREAMY LIP BALM HIDRATANTE EN BARRA PARA LABIOS 24H FPS 12 CORAL CREAMY3 g in 1 TUBESTICK34
14141-309-01CYZONE CY PLAY CREAMY LIP BALM HIDRATANTE EN BARRA PARA LABIOS 24H FPS 12 CORAL CREAMY1 in 1 CARTONSTICK14
14141-348-01CYZONE CY PLAY CREAMY LIP BALM HIDRATANTE EN BARRA PARA LABIOS 24H FPS 12 BERRY CREAMY1 in 1 CARTONSTICK14
14141-348-01CYZONE CY PLAY CREAMY LIP BALM HIDRATANTE EN BARRA PARA LABIOS 24H FPS 12 BERRY CREAMY3 g in 1 TUBESTICK34
14141-349-01CYZONE CY PLAY CREAMY LIP BALM HIDRATANTE EN BARRA PARA LABIOS 24H FPS 12 CHERRY CREAMY1 in 1 CARTONSTICK14
14141-349-01CYZONE CY PLAY CREAMY LIP BALM HIDRATANTE EN BARRA PARA LABIOS 24H FPS 12 CHERRY CREAMY3 g in 1 TUBESTICK34

Products#

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

DailyMed product names page 1 of 2 · 62 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
14141-30914141-309-01
14141-30614141-306-01
14141-30714141-307-01
14141-30814141-308-01
14141-34914141-349-01
14141-34814141-348-01

Ingredients#

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

DailyMed ingredient rows page 1 of 9 · 330 matching rows.

Name, UNII, Kind table
NameUNIIKind
SHOREA ROBUSTA RESINXUK1106UBOIACT
LAUROYL LYSINE113171Q70BIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
D&C RED NO. 302S42T2808BIACT
GRAPEFRUITO82C39RR8CIACT
ASCORBYL PALMITATEQN83US2B0NIACT
TOCOPHEROLR0ZB2556P8IACT
.BETA.-CITRONELLOL, (R)-P01OUT964KIACT
MICAV8A1AW0880IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
CARNAUBA WAXR12CBM0EIZIACT
CORN OIL8470G57WFMIACT
D&C RED NO. 7ECW0LZ41X8IACT
FERROSOFERRIC OXIDEXM0M87F357IACT
ZINC OXIDESOI2LOH54ZACTIB
D&C RED NO. 272LRS185U6KIACT
FERRIC OXIDE RED1K09F3G675IACT
FD&C BLUE NO. 1 ALUMINUM LAKEJ9EQA3S2JMIACT
OCTINOXATE4Y5P7MUD51ACTIB
SWEET CHERRY SEED OIL9X3RP3RJFHIACT
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATEVLW429K27KIACT
CAPRYLYL GLYCOL00YIU5438UIACT
CHLORPHENESINI670DAL4SZIACT
WATER059QF0KO0RIACT
LECITHIN, SUNFLOWER834K0WOS5GIACT
HIGH DENSITY POLYETHYLENEUG00KM4WR7IACT
GLYCERINPDC6A3C0OXIACT
RICE BRAN OILLZO6K1506AIACT
OLEA EUROPAEA (OLIVE) OIL UNSAPONIFIABLESXO45V955LTIACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
PALMITIC ACID2V16EO95H1IACT
TALC7SEV7J4R1UIACT
HELIANTHUS ANNUUS SEED WAX42DG15CHXVIACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
CRANBERRY SEED OIL73KDS3BW5EIACT
FD&C RED NO. 40WZB9127XOAIACT
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDEYK3DC63Y5MIACT
RICE BRANR60QEP13ICIACT
PHENOXYETHANOLHIE492ZZ3TIACT
APPLE SEED OIL9ACA4K9013IACT

Source Document#

Source XML

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
CYZONE CY PLAY CREAMY LIP BALM HIDRATANTE EN BARRA PARA LABIOS 24H FPS 12 FUCHSIA CREAMYOCTINOXATE, ZINC OXIDEBEL STAR S Aea39a1c0-6b12-77ba-e053-2995a90a73142025-08-21WarningsExact identifier
ndc (package): 14141-349-01
ndc (package): 14141-307-01
ndc (package): 14141-308-01
ndc (package): 14141-348-01
ndc (package): 14141-306-01
ndc (package): 14141-309-01
ndc (product): 14141-309
ndc (product): 14141-348
ndc (product): 14141-308
ndc (product): 14141-307
ndc (product): 14141-306
ndc (product): 14141-349
ndc11 (package): 14141034901
ndc11 (package): 14141030801
ndc11 (package): 14141030601
ndc11 (package): 14141034801
ndc11 (package): 14141030901
ndc11 (package): 14141030701
spl id: 3ce46bfb-8d6d-05f6-e063-6394a90aac2f
spl set id: ea39a1c0-6b12-77ba-e053-2995a90a7314

Reported adverse events (FAERS/openFDA)#

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