CYZONE  CY SOLUXION ACLARADORA FPS 15- octinoxate and oxybenzone cream 
Ventura Corporation LTD.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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CYZONE CREMA CY SOLUXION Aclaradora FPS 15

Información del medicamento

Ingredientes activos Propósito
Octinoxate 7.5% Protector solar
Oxybenzone 4.5% Protector solar

Usos

Advertencias

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.
  • Sólo para uso externo.

  • No usar en piel dañada o lastimada.

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

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

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

Instrucciones

Otra información

Ingredientes inactivos

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.

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

PRINCIPAL DISPLAY PANEL - 50 g Bottle Carton

CREMA

CY
SOLUXION
cy°zone

ACLARADORA
FPS 15

FAVORECE EL
EMPAREJAMIENTO DEL
TONO DE LA PIEL E
IMPERFECCIONES
AYUDA A PROTEGER DEL
MEDIO AMBIENTE

RECOMENDADO
POR L'BEL

50 g e (1.7 oz.)

Principal Display Panel - 50 g Bottle Carton
CYZONE   CY SOLUXION ACLARADORA FPS 15
octinoxate and oxybenzone cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-449
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.075 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 0.045 g  in 1 g
Inactive Ingredients
Ingredient Name Strength
water (UNII: 059QF0KO0R)  
cyclomethicone 5 (UNII: 0THT5PCI0R)  
glyceryl monostearate (UNII: 230OU9XXE4)  
alkyl (c12-15) benzoate (UNII: A9EJ3J61HQ)  
peg-100 stearate (UNII: YD01N1999R)  
dicaprylyl carbonate (UNII: 609A3V1SUA)  
cetyl alcohol (UNII: 936JST6JCN)  
propylene glycol (UNII: 6DC9Q167V3)  
glycerin (UNII: PDC6A3C0OX)  
phenoxyethanol (UNII: HIE492ZZ3T)  
dimethicone (UNII: 92RU3N3Y1O)  
cyclomethicone 6 (UNII: XHK3U310BA)  
methylparaben (UNII: A2I8C7HI9T)  
papain (UNII: A236A06Y32)  
trolamine (UNII: 9O3K93S3TK)  
titanium dioxide (UNII: 15FIX9V2JP)  
propylparaben (UNII: Z8IX2SC1OH)  
edetate sodium (UNII: MP1J8420LU)  
calcium pantothenate (UNII: 568ET80C3D)  
xanthan gum (UNII: TTV12P4NEE)  
caprylyl glycol (UNII: 00YIU5438U)  
urea (UNII: 8W8T17847W)  
butylparaben (UNII: 3QPI1U3FV8)  
magnesium lactate (UNII: MT6QI8324A)  
ethylparaben (UNII: 14255EXE39)  
ethylhexylglycerin (UNII: 147D247K3P)  
potassium lactate (UNII: 87V1KMK4QV)  
isobutylparaben (UNII: 0QQJ25X58G)  
methylpropanediol (UNII: N8F53B3R4R)  
4-carvomenthenol (UNII: L65MV77ZG6)  
alanine (UNII: OF5P57N2ZX)  
magnesium chloride (UNII: 02F3473H9O)  
proline (UNII: 9DLQ4CIU6V)  
serine (UNII: 452VLY9402)  
sodium citrate (UNII: 1Q73Q2JULR)  
salicylic acid (UNII: O414PZ4LPZ)  
willow bark (UNII: S883J9JDYX)  
arctium lappa root (UNII: 597E9BI3Z3)  
lemon peel (UNII: 72O054U628)  
gentiana lutea root (UNII: S72O3284MS)  
juniper berry (UNII: O84B5194RL)  
thyme (UNII: CW657OBU4N)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:13537-449-02 1 in 1 CARTON
1 NDC:13537-449-01 50 g in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part352 02/01/2013
Labeler - Ventura Corporation LTD. (602751344)
Establishment
Name Address ID/FEI Business Operations
Bel Star S.A. (Colombia) 880160197 MANUFACTURE(13537-449)
Establishment
Name Address ID/FEI Business Operations
Yobel Supply Chain Management S.A. (Peru) 934116930 MANUFACTURE(13537-449)

Revised: 2/2013
Document Id: c0d42f77-a9ac-4d0b-967a-91b8d868ed4e
Set id: 8fbeca28-99fd-4899-a9a9-bd9c6b8a6e8c
Version: 1
Effective Time: 20130201
 
Ventura Corporation LTD.