CYZONE- octinoxate and octocrylene ointment

CYZONE by

Drug Labeling and Warnings

CYZONE by is a Otc medication manufactured, distributed, or labeled by Ventura Corporation Limited, BelStar, S.A.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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).

SPL UNCLASSIFIED SECTION

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.)

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PRINCIPAL DISPLAY PANEL - 14 g PassionBerry Container

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

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PRINCIPAL DISPLAY PANEL - 14 g MintGrape Container

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

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PRINCIPAL DISPLAY PANEL - 14 g CocoPine Container

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

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INGREDIENTS AND APPEARANCE

CYZONE   CY
octinoxate and octocrylene ointment

Product 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 ointment

Product 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 ointment

Product 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 ointment

Product 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