CYZONE  BETTER LIPS BALM- octinoxate, oxybenzone, and zinc oxide lipstick 
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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cy°
cy°zone
better lips balm

Active Ingredients

Octinoxate 7%, Oxybenzone 2%, Zinc Oxide 1%.

Purpose

Sunscreen.

Uses

Helps prevent sunburn.

Warnings

Stop use if skin rash occurs.

Inactive ingredients

Caprylic/capric triglyceride, diisopropyl dimer dilinoleate, ricinus communis seed oil (ricinus communis (castor) seed oil), octyldodecanol, hydrogenated polyisobutene, polyethylene, candelilla cera (euphorbia cerifera (candelilla) wax), cera alba (beeswax), copernicia cerifera cera (copernicia cerifera (carnauba) wax), CI 77019 (mica), parfum (fragrance), dipalmitoyl hydroxyproline, glyceryl isostearate, isostearyl alcohol, glycerin, butyrospermum parkii (butyrospermum parkii (shea butter), bertholletia excelsa seed oil, orbignya oleifera seed oil, tocopheryl acetate, beta-sitosterol, sodium saccharin, silica dimethyl silylate, cetearyl ethylhexanoate, propylparaben, cera microcristallina (microcrystalline wax), bht, butyl methoxydibenzoylmethane, petrolatum, cetyl alcohol, phospholipids, hydrogenated coconut oil, ethylhexyl salicylate, cholesterol, oleyl alcohol, triethoxycaprylylsilane, ozokerite, dimethicone, polyglyceryl-2 dipolyhydroxystearate, cetearyl glucoside, cetearyl alcohol, cetyl ricinoleate, glycosphingolipids, trimethylsiloxysilicate. May Contain: Calcium aluminum borosilicate, CI 77891 (titanium dioxide), CI 45380 (red 21 lake), CI 15850 (red 7 lake), CI 45410 (red 27 lake), CI 16035 (red 40 lake), CI 77491 (iron oxides), CI 77492 (iron oxides), silica, CI 19140 (yellow 5 lake), talc, CI 77499 (iron oxides), tin oxide, CI 75470 (carmine), palmitic acid, methylparaben, butylparaben.

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

PRINCIPAL DISPLAY PANEL - 4,5 g Label

better lips balm

Humectante para labios
con color FPS 18 UVA UVB

cy°

cy°zone
4,5 g e (.15 oz.)

PRINCIPAL DISPLAY PANEL - 4,5 g Label
CYZONE   BETTER LIPS BALM
octinoxate, oxybenzone, and zinc oxide lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-300
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate70 mg  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone20 mg  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
CASTOR OIL (UNII: D5340Y2I9G)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
CANDELILLA WAX (UNII: WL0328HX19)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
MICA (UNII: V8A1AW0880)  
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)  
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
GLYCERIN (UNII: PDC6A3C0OX)  
SHEA BUTTER (UNII: K49155WL9Y)  
BRAZIL NUT OIL (UNII: 0G89T29HO6)  
BABASSU OIL (UNII: 8QSB4M5477)  
.BETA.-SITOSTEROL (UNII: S347WMO6M4)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
AVOBENZONE (UNII: G63QQF2NOX)  
PETROLATUM (UNII: 4T6H12BN9U)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
HYDROGENATED COCONUT OIL (UNII: JY81OXM1OM)  
OCTISALATE (UNII: 4X49Y0596W)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
OLEYL ALCOHOL (UNII: 172F2WN8DV)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
TALC (UNII: 7SEV7J4R1U)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
STANNIC OXIDE (UNII: KM7N50LOS6)  
PALMITIC ACID (UNII: 2V16EO95H1)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-300-011 in 1 BOX
1NDC:13537-300-024.5 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35202/28/2011
Labeler - Ventura Corporation Ltd. (602751344)

Revised: 2/2011
Document Id: 383c5b05-b1ce-4915-af8d-4e7ca45adb2c
Set id: 9fea0a88-ab56-4b2e-b695-b24cd48fb1a8
Version: 1
Effective Time: 20110222
 
Ventura Corporation Ltd.