CYZONE  CY- octinoxate and octocrylene ointment 
Ventura Corporation Limited

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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humectante para labios
con aroma FPS 15
cy°zone
cy°bulkyz

Active Ingredients

Octinoxate: 6.0%, Octocrylene: 4,0%.

Purpose

Sunscreen.

Uses

Helps prevent sunburn.

Warnings

Stop use if skin rash occurs.

Ingredients

Diisopropyl dimer dilinoleate, petrolatum, polybutene, butyrospermum parkii (butyrospermum parkii (shea butter)), cera alba (beeswax), silica, cera microcristallina (microcrystalline wax), parfum (fragrance), silica dimethyl silylate, bht, caprylic/capric triglyceride, diethylhexyl syringylidene malonate, glycerin, methylparaben, ozokerite, propylparaben, sodium saccharin, theobroma cacao seed butter (theobroma cacao (cocoa) seed butter), tocopheryl acetate. May contain: CI 77019 (mica), CI 45380 (red 21 lake), CI 77891 (titanium dioxide), CI 15850 (red 7 lake), CI 19140 (yellow 5 lake), CI 42090 (blue 1 lake), CI 45410 (red 27 lake).

P.R.:Dist. by Ventura Corporation, Ltd., San Juan, Puerto Rico 00926. Made in Colombia.

PRINCIPAL DISPLAY PANEL - 14 g CherryLemon Container

humectante para labios con aroma FPS 15
14 g e (.49 oz.)

cy°bulkyz

Principal Display Panel - 14 g CherryLemon Container

PRINCIPAL DISPLAY PANEL - 14 g PassionBerry Container

humectante para labios con aroma FPS 15
14 g e (.49 oz.)

cy°bulkyz

Principal Display Panel - 14 g PassionBerry Container

PRINCIPAL DISPLAY PANEL - 14 g MintGrape Container

humectante para labios con aroma FPS 15
14 g e (.49 oz.)

cy°bulkyz

Principal Display Panel - 14 g MintGrape Container

PRINCIPAL DISPLAY PANEL - 14 g CocoPine Container

humectante para labios con aroma FPS 15
14 g e (.49 oz.)

cy°bulkyz

Principal Display Panel - 14 g CocoPine Container
CYZONE   CY
octinoxate and octocrylene ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-012
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.06 g  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE0.04 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM (UNII: 4T6H12BN9U)  
SHEA BUTTER (UNII: K49155WL9Y)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
GLYCERIN (UNII: PDC6A3C0OX)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
CERESIN (UNII: Q1LS2UJO3A)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
CHOCOLATE (UNII: D9108TZ9KG)  
MICA (UNII: V8A1AW0880)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
Aluminum Oxide (UNII: LMI26O6933)  
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRY, LEMONImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-012-151 in 1 CARTON
1NDC:13537-012-1414 g in 1 CONTAINER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35201/21/2011
CYZONE   CY
octinoxate and octocrylene ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-013
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.06 g  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE0.04 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM (UNII: 4T6H12BN9U)  
SHEA BUTTER (UNII: K49155WL9Y)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
GLYCERIN (UNII: PDC6A3C0OX)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
CERESIN (UNII: Q1LS2UJO3A)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
CHOCOLATE (UNII: D9108TZ9KG)  
MICA (UNII: V8A1AW0880)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
Aluminum Oxide (UNII: LMI26O6933)  
Product Characteristics
Color    Score    
ShapeSize
FlavorBERRY (PassionBerry) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-013-151 in 1 CARTON
1NDC:13537-013-1414 g in 1 CONTAINER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35201/21/2011
CYZONE   CY
octinoxate and octocrylene ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-014
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.06 g  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE0.04 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM (UNII: 4T6H12BN9U)  
SHEA BUTTER (UNII: K49155WL9Y)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
GLYCERIN (UNII: PDC6A3C0OX)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
CERESIN (UNII: Q1LS2UJO3A)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
CHOCOLATE (UNII: D9108TZ9KG)  
MICA (UNII: V8A1AW0880)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
Aluminum Oxide (UNII: LMI26O6933)  
Product Characteristics
Color    Score    
ShapeSize
FlavorMINT, GRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-014-151 in 1 CARTON
1NDC:13537-014-1414 g in 1 CONTAINER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35201/21/2011
CYZONE   CY
octinoxate and octocrylene ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-015
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.06 g  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE0.04 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM (UNII: 4T6H12BN9U)  
SHEA BUTTER (UNII: K49155WL9Y)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
GLYCERIN (UNII: PDC6A3C0OX)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
CERESIN (UNII: Q1LS2UJO3A)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
CHOCOLATE (UNII: D9108TZ9KG)  
MICA (UNII: V8A1AW0880)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
Aluminum Oxide (UNII: LMI26O6933)  
Product Characteristics
Color    Score    
ShapeSize
FlavorCOCONUT (CocoPine) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-015-151 in 1 CARTON
1NDC:13537-015-1414 g in 1 CONTAINER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35201/21/2011
Labeler - Ventura Corporation Limited (602751344)
Establishment
NameAddressID/FEIBusiness Operations
BelStar, S.A.880160197MANUFACTURE

Revised: 11/2010
Document Id: 764bfb1d-d860-46a5-9120-9cd2b2b9d815
Set id: 1f7711ff-ca6c-4891-8eb3-808c8c7d1338
Version: 1
Effective Time: 20101110
 
Ventura Corporation Limited