Label: CYZONE- octinoxate and octocrylene ointment
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Contains inactivated NDC Code(s)
NDC Code(s): 13537-012-14, 13537-012-15, 13537-013-14, 13537-013-15, view more13537-014-14, 13537-014-15, 13537-015-14, 13537-015-15 - Packager: Ventura Corporation Limited
- 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 November 10, 2010
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Uses
- Warnings
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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).
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 14 g CherryLemon Container
- PRINCIPAL DISPLAY PANEL - 14 g PassionBerry Container
- PRINCIPAL DISPLAY PANEL - 14 g MintGrape Container
- PRINCIPAL DISPLAY PANEL - 14 g CocoPine Container
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INGREDIENTS AND APPEARANCE
CYZONE CY
octinoxate and octocrylene ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-012 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.06 g in 1 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 0.04 g in 1 g Inactive Ingredients Ingredient Name Strength 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 Shape Size Flavor CHERRY, LEMON Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-012-15 1 in 1 CARTON 1 NDC:13537-012-14 14 g in 1 CONTAINER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 01/21/2011 CYZONE CY
octinoxate and octocrylene ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-013 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.06 g in 1 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 0.04 g in 1 g Inactive Ingredients Ingredient Name Strength 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 Shape Size Flavor BERRY (PassionBerry) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-013-15 1 in 1 CARTON 1 NDC:13537-013-14 14 g in 1 CONTAINER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 01/21/2011 CYZONE CY
octinoxate and octocrylene ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-014 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.06 g in 1 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 0.04 g in 1 g Inactive Ingredients Ingredient Name Strength 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 Shape Size Flavor MINT, GRAPE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-014-15 1 in 1 CARTON 1 NDC:13537-014-14 14 g in 1 CONTAINER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 01/21/2011 CYZONE CY
octinoxate and octocrylene ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-015 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.06 g in 1 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 0.04 g in 1 g Inactive Ingredients Ingredient Name Strength 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 Shape Size Flavor COCONUT (CocoPine) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-015-15 1 in 1 CARTON 1 NDC:13537-015-14 14 g in 1 CONTAINER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 01/21/2011 Labeler - Ventura Corporation Limited (602751344) Establishment Name Address ID/FEI Business Operations BelStar, S.A. 880160197 MANUFACTURE