CYZONE

Manufacturer
Ventura Corporation LTD. | Bel Star S.A. (Colombia) | Yobel Supply Chain Management S.A. (Peru)
Effective date
2012-07-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:46:44

Label at a glance#

ProductCYZONE CY SOLUXION desmanchadora FPS 15
Active ingredientOctinoxate, Oxybenzone
Label structure9 sections

Storage and handling

Proteja el producto del calor excesivo y del sol directo.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Información del medicamento

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Ingredientes activosPropósito
Octinoxate 7.5%Protector solar
Oxybenzone 4.5%Protector solar

Usos

INDICATIONS & USAGE SECTION

  • Ayuda a prevenir quemaduras solares

Advertencias

WARNINGS SECTION

SPL UNCLASSIFIED SECTION

  • Alerta de Cáncer en la piel / envejecimiento de la piel : Pasar tiempo bajo el sol incrementa el riesgo de cáncer y envejecimiento prematuro de la piel. Este producto ha demostrado que unicamente ayuda a prevenir las quemaduras solares pero no previene el cáncer a la piel ni el envejecimiento prematuro de la misma.

OTC - DO NOT USE SECTION

  • Sólo para uso externo.
  • No usar en piel dañada o lastimada.

OTC - WHEN USING SECTION

  • Cuando use este producto mantener alejado de los ojos. Enjuagar con agua para eliminar.

OTC - STOP USE SECTION

  • Detenga su uso y consulte al doctor si sucede enrojecimiento.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • Mantener fuera del alcance de los niños. Si es ingerido obtener ayuda médica o contactar al centro de Control de Envenenamiento inmediatamente

Instrucciones

DOSAGE & ADMINISTRATION SECTION

  • Aplicar generosamente y uniformemente 15 minutos antes de la exposición al sol.
  • Reaplicar por lo menos cada dos horas.
  • Use un protector solar resistente al agua si usted nada o suda.
  • Niños menores a 6 meses de edad: Consulte al médico

Otra información

STORAGE AND HANDLING SECTION

  • Proteja el producto del calor excesivo y del sol directo.

Ingredientes inactivos

INACTIVE INGREDIENT SECTION

Aqua (water), cyclopentasiloxane, glyceryl stearate, c12-15 alkyl benzoate, peg-100 stearate, dicaprylyl carbonate, cetyl alcohol, propylene glycol, glycerin, phenoxyethanol, dimethicone, cyclohexasiloxane, methyl methacrylate crosspolymer, methylparaben, papain, triethanolamine, acrylates/c10-30 alkyl acrylate crosspolymer, ci 77891 (titanium dioxide), propylparaben, parfum (fragrance), castoryl maleate, tetrasodium edta, calcium pantothenate, xanthan gum, caprylyl glycol, urea, butylparaben, magnesium lactate, ethylparaben, ethylhexylglycerin, potassium lactate, isobutylparaben, methylpropanediol, 4-terpineol, alanine, magnesium chloride, proline, serine, sodium citrate, salicylic acid, salix alba bark extract (salix alba (willow) bark extract), arctium majus root extract, citrus limon peel extract (citrus limon (lemon) peel extract ), gentiana lutea root extract, juniperus communis fruit extract, thymus vulgaris (thyme) flower/leaf extract.

SPL UNCLASSIFIED SECTION

Distributed by Ventura Corporation, Ltd., San Juan, Puerto Rico 00926.

PRINCIPAL DISPLAY PANEL - 50 g Jar Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CREMA

CY
SOLUXION

cy°zone

DESMANCHADORA
FPS 15

  • FAVORECE EL
    EMPAREJAMIENTO DEL
    TONO DE LA PIEL E
    IMPERFECCIONES
  • PROTEGE DE RAYOS UVB

RECOMENDADO
POR L'BEL

50 g e (1.7 oz.)

PRINCIPAL DISPLAY PANEL - 50 g Jar Carton
PRINCIPAL DISPLAY PANEL - 50 g Jar Carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
13537-433-012025-04-24C16284748780-197449f38-cf62-f6ea-e053-dbdaa90aa703CYZONE CREMA CY SOLUXION desmanchadora FPS 15
13537-433-012019-11-13C16284748780-197449f38-cf62-f6ea-e053-dbdaa90aa703CYZONE CREMA CY SOLUXION desmanchadora FPS 15

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
OctinoxateACTIVE INGREDIENT4Y5P7MUD511
OxybenzoneACTIVE INGREDIENT95OOS7VE0Y1
OctinoxateACTIVE MOIETY4Y5P7MUD511
OxybenzoneACTIVE MOIETY95OOS7VE0Y1
4-carvomenthenolINACTIVE INGREDIENTL65MV77ZG61
alanineINACTIVE INGREDIENTOF5P57N2ZX1
alkyl (c12-15) benzoateINACTIVE INGREDIENTA9EJ3J61HQ1
arctium lappa rootINACTIVE INGREDIENT597E9BI3Z31
butylparabenINACTIVE INGREDIENT3QPI1U3FV81
calcium pantothenateINACTIVE INGREDIENT568ET80C3D1
caprylyl glycolINACTIVE INGREDIENT00YIU5438U1
cetyl alcoholINACTIVE INGREDIENT936JST6JCN1
cyclomethicone 5INACTIVE INGREDIENT0THT5PCI0R1
cyclomethicone 6INACTIVE INGREDIENTXHK3U310BA1
dicaprylyl carbonateINACTIVE INGREDIENT609A3V1SUA1
dimethiconeINACTIVE INGREDIENT92RU3N3Y1O1
edetate sodiumINACTIVE INGREDIENTMP1J8420LU1
ethylhexylglycerinINACTIVE INGREDIENT147D247K3P1
ethylparabenINACTIVE INGREDIENT14255EXE391
gentiana lutea rootINACTIVE INGREDIENTS72O3284MS1
glycerinINACTIVE INGREDIENTPDC6A3C0OX1
glyceryl monostearateINACTIVE INGREDIENT230OU9XXE41
isobutylparabenINACTIVE INGREDIENT0QQJ25X58G1
juniper berryINACTIVE INGREDIENTO84B5194RL1
lemon peelINACTIVE INGREDIENT72O054U6281
magnesium chlorideINACTIVE INGREDIENT02F3473H9O1
magnesium lactateINACTIVE INGREDIENTMT6QI8324A1
methylparabenINACTIVE INGREDIENTA2I8C7HI9T1
methylpropanediolINACTIVE INGREDIENTN8F53B3R4R1
papainINACTIVE INGREDIENTA236A06Y321
peg-100 stearateINACTIVE INGREDIENTYD01N1999R1
phenoxyethanolINACTIVE INGREDIENTHIE492ZZ3T1
potassium lactateINACTIVE INGREDIENT87V1KMK4QV1
prolineINACTIVE INGREDIENT9DLQ4CIU6V1
propylene glycolINACTIVE INGREDIENT6DC9Q167V31
propylparabenINACTIVE INGREDIENTZ8IX2SC1OH1
salicylic acidINACTIVE INGREDIENTO414PZ4LPZ1
salix alba barkINACTIVE INGREDIENT205MXS71H71
serineINACTIVE INGREDIENT452VLY94021
sodium citrateINACTIVE INGREDIENT1Q73Q2JULR1
thymeINACTIVE INGREDIENTCW657OBU4N1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JP1
trolamineINACTIVE INGREDIENT9O3K93S3TK1
ureaINACTIVE INGREDIENT8W8T17847W1
waterINACTIVE INGREDIENT059QF0KO0R1
xanthan gumINACTIVE INGREDIENTTTV12P4NEE1

Products#

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

DailyMed product names page 1 of 2 · 46 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
13537-43313537-433-01

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 44 matching rows.

Source Document#

Source XML

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.

Inactive ingredient links page 1 of 9 · 496 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
methylparabenMETHYLPARABENA2I8C7HI9TSUPPOSITORY / VAGINALNAExact identifier — unii candidate
79 equally ranked IID candidates
glyceryl monostearateGLYCERYL MONOSTEARATE230OU9XXE4CAPSULE, EXTENDED RELEASE / ORAL32.4 mgExact identifier — unii candidate
21 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPCAPSULE, DELAYED RELEASE PELLETS / ORAL24 mgExact identifier — unii candidate
40 equally ranked IID candidates
glyceryl monostearateGLYCERYL MONOSTEARATE230OU9XXE4TABLET / ORAL33.34 mgExact identifier — unii candidate
21 equally ranked IID candidates
phenoxyethanolPHENOXYETHANOLHIE492ZZ3TCREAM, AUGMENTED / TOPICAL10 mgExact identifier — unii candidate
6 equally ranked IID candidates
phenoxyethanolPHENOXYETHANOLHIE492ZZ3TAEROSOL, FOAM / TOPICAL72 mgExact identifier — unii candidate
6 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SOLUTION/ DROPS / AURICULAR (OTIC)ADJ PHExact identifier — unii candidate
81 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXGEL / TRANSDERMAL500 mgExact identifier — unii candidate
75 equally ranked IID candidates
xanthan gumXANTHAN GUMTTV12P4NEESUSPENSION / RECTAL452 mgExact identifier — unii candidate
29 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SUSPENSION, EXTENDED RELEASE / ORAL1000 mgExact identifier — unii candidate
81 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TLOTION / TOPICAL351 mgExact identifier — unii candidate
79 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHPOWDER, FOR SUSPENSION / ORAL8 mgExact identifier — unii candidate
68 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TSOLUTION / RESPIRATORY (INHALATION)0.03 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TTABLET, EXTENDED RELEASE / ORAL0.17 mgExact identifier — unii candidate
79 equally ranked IID candidates
edetate sodiumEDETATE SODIUMMP1J8420LUINJECTION / INTRAMUSCULAR0.01 %w/vExact identifier — unii candidate
12 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3TABLET, DELAYED RELEASE / ORAL36 mgExact identifier — unii candidate
81 equally ranked IID candidates
edetate sodiumEDETATE SODIUMMP1J8420LUTABLET / ORAL5 mgExact identifier — unii candidate
12 equally ranked IID candidates
magnesium chlorideMAGNESIUM CHLORIDE02F3473H9OSUSPENSION / AURICULAR (OTIC)0.06 %w/wExact identifier — unii candidate
7 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3TABLET, COATED / ORAL16 mgExact identifier — unii candidate
81 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SOLUTION, CONCENTRATE / ORAL2590 mgExact identifier — unii candidate
81 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHINJECTION / SOFT TISSUE0.02 %w/vExact identifier — unii candidate
68 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXGUM, CHEWING / BUCCAL230 mgExact identifier — unii candidate
75 equally ranked IID candidates
glyceryl monostearateGLYCERYL MONOSTEARATE230OU9XXE4SUSPENSION / AURICULAR (OTIC)0.5 %w/vExact identifier — unii candidate
21 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXGEL / TOPICAL500 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSOLUTION / OPHTHALMIC6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSOLUTION / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
cetyl alcoholCETYL ALCOHOL936JST6JCNTABLET, COATED / ORAL0.25 mgExact identifier — unii candidate
20 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SOLUTION / DENTAL2 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKCREAM / VAGINAL56 mgExact identifier — unii candidate
22 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHCREAM / TOPICAL6 mgExact identifier — unii candidate
68 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TINJECTION / INTRA-ARTICULAR0.24 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
phenoxyethanolPHENOXYETHANOLHIE492ZZ3TCREAM / TOPICAL57 mgExact identifier — unii candidate
6 equally ranked IID candidates
cyclomethicone 5CYCLOMETHICONE 50THT5PCI0RCREAM, AUGMENTED / TOPICAL260 mgExact identifier — unii candidate
3 equally ranked IID candidates
cetyl alcoholCETYL ALCOHOL936JST6JCNAEROSOL, FOAM / VAGINAL0.75 %w/wExact identifier — unii candidate
20 equally ranked IID candidates
xanthan gumXANTHAN GUMTTV12P4NEETABLET / ORAL56 mgExact identifier — unii candidate
29 equally ranked IID candidates
butylparabenBUTYLPARABEN3QPI1U3FV8SOLUTION / RECTAL0.01 %w/vExact identifier — unii candidate
15 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPOINTMENT / TOPICAL5 %w/wExact identifier — unii candidate
40 equally ranked IID candidates
glyceryl monostearateGLYCERYL MONOSTEARATE230OU9XXE4SUSPENSION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
21 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3TABLET, FILM COATED, EXTENDED RELEASE / ORAL19 mgExact identifier — unii candidate
81 equally ranked IID candidates
xanthan gumXANTHAN GUMTTV12P4NEESUSPENSION/ DROPS / ORAL22 mgExact identifier — unii candidate
29 equally ranked IID candidates
cetyl alcoholCETYL ALCOHOL936JST6JCNSUSPENSION / AURICULAR (OTIC)1 %w/vExact identifier — unii candidate
20 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TGEL / VAGINAL8 mgExact identifier — unii candidate
79 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TINJECTION / EPIDURAL1 mgExact identifier — unii candidate
79 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3EMULSION / OPHTHALMIC1.5 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TSUSPENSION / TOPICAL0.24 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
serineSERINE452VLY9402INJECTION / INTRAVENOUS0.5 %w/vExact identifier — unii candidate
2 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TAEROSOL, FOAM / VAGINAL0.1 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSOLUTION/ DROPS / OPHTHALMIC12 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXJELLY / VAGINALNAExact identifier — unii candidate
75 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TINJECTION / INFILTRATION80 mgExact identifier — unii candidate
79 equally ranked IID candidates
glyceryl monostearateGLYCERYL MONOSTEARATE230OU9XXE4TABLET, CHEWABLE / ORAL1 mgExact identifier — unii candidate
21 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TSUSPENSION / AURICULAR (OTIC)NAExact identifier — unii candidate
79 equally ranked IID candidates
magnesium chlorideMAGNESIUM CHLORIDE02F3473H9OSOLUTION / INTRAPERITONEAL0.01 %w/vExact identifier — unii candidate
7 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHSOLUTION/ DROPS / OPHTHALMIC0.01 %w/vExact identifier — unii candidate
68 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHFILM, SOLUBLE / BUCCAL1 mgExact identifier — unii candidate
68 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHLIQUID / TOPICAL0.1 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
magnesium chlorideMAGNESIUM CHLORIDE02F3473H9OSOLUTION/ DROPS / OPHTHALMIC0.03 %w/vExact identifier — unii candidate
7 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSOLUTION, CONCENTRATE / ORAL200 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXTABLET, FILM COATED / ORAL1.55 mgExact identifier — unii candidate
75 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TDROPS / NASAL26 mgExact identifier — unii candidate
79 equally ranked IID candidates

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
338b6895-7897-8842-e063-6394a90aabf6b0556d02-2c6c-4857-b4ed-fed27e209d582025-04-24WarningsExact identifier
spl set id: b0556d02-2c6c-4857-b4ed-fed27e209d58

Reported adverse events (FAERS/openFDA)#

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