Label: CYZONE- octinoxate, oxybenzone, and zinc oxide lipstick
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Contains inactivated NDC Code(s)
NDC Code(s): 13537-300-01, 13537-300-02 - Packager: Ventura Corporation Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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 22, 2011
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- Active Ingredients
- Purpose
- Uses
- Warnings
- STOP USE
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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.
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 4,5 g Label
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INGREDIENTS AND APPEARANCE
CYZONE BETTER LIPS BALM
octinoxate, oxybenzone, and zinc oxide lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-300 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 70 mg in 1 g Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 20 mg in 1 g Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 10 mg in 1 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-300-01 1 in 1 BOX 1 NDC:13537-300-02 4.5 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 02/28/2011 Labeler - Ventura Corporation Ltd. (602751344)
