Label: CYZONE CY SOLUXION ACLARADORA FPS 15- octinoxate and oxybenzone cream
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Contains inactivated NDC Code(s)
NDC Code(s): 13537-449-01, 13537-449-02 - Packager: Ventura Corporation LTD.
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated February 1, 2013
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Usos
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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.
- Instrucciones
- Otra información
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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.
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 50 g Bottle Carton
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INGREDIENTS AND APPEARANCE
CYZONE CY SOLUXION ACLARADORA FPS 15
octinoxate and oxybenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-449 Route of Administration TOPICAL 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)
