CYZONE CY PERLIPS LABIAL HIDRATANTE CON PERLAS DE LUZ Y FPS 20- octinoxate and oxybenzone cream

CYZONE by

Drug Labeling and Warnings

CYZONE by is a Otc medication manufactured, distributed, or labeled by Ventura Corporation LTD., Bel Star S.A. (Colombia), Yobel Supply Chain Management S.A. (Peru). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

OCTINOXATE 7.0 % , OXYBENZONE 2.5 %

Purpose

Sunscreen

Uses

• Helps prevent sunburn

Warnings

• Skin Cancer / Skin Aging Alert; Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.
• For external use only.

• Do not use on damage or broken skin.

• When using this product keep out of eyes. Rinse with water to remove.

• Stop use and ask a doctor if rash occurs.

• Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Apply liberally and evenly 15 minutes before sun exposure.
• Children under 6 months of age: Ask a doctor.
• Reapply at least every 2 hours.
• Use a water resistant sunscreen if swimming or sweating.

Other information

• Protect the product in this container from excessive heat and direct sun.

Inactive ingredients

RICINUS COMMUNIS SEED OIL (RICINUS COMMUNIS (CASTOR) SEED OIL), CAPRYLIC/CAPRIC TRIGLYCERIDE, POLYETHYLENE, CERA ALBA (BEESWAX), CANDELILLA CERA (EUPHORBIA CERIFERA (CANDELILLA) WAX), HYDROGENATED VEGETABLE OIL, BUTYROSPERMUM PARKII BUTTER (BUTYROSPERMUM PARKII (SHEA) BUTTER), SILICA DIMETHYL SILYLATE, GLYCERIN, OCTYLDODECANOL, PARFUM (FRAGRANCE), GLYCERYL ISOSTEARATE, ISOSTEARYL ALCOHOL, HELIANTHUS ANNUUS SEED OIL (HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL), SODIUM SACCHARIN, PROPYLPARABEN, MICROCRISTALLINA CERA (MICROCRYSTALLINE WAX), BETA-SITOSTEROL, PETROLATUM, BHT, TOCOPHERYL ACETATE, PHOSPHOLIPIDS, CHOLESTEROL, CETEARYL ALCOHOL, CETEARYL GLUCOSIDE, COPERNICIA CERIFERA CERA (COPERNICIA CERIFERA (CARNAUBA ) WAX), POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE, GLYCOSPHINGOLIPIDS. May contain:: CI 77742 (MANGANESE VIOLET), CI 15850 (RED 7 LAKE), CI 77492 (IRON OXIDES), CI 77891 (TITANIUM DIOXIDE ), SYNTHETIC FLUORPHLOGOPITE, CI 19140 (YELLOW 5 LAKE), CI 73360 (RED 30).

SPL UNCLASSIFIED SECTION

Distributed by Ventura Corporation, Ltd., San Juan, Puerto Rico 00926.

PRINCIPAL DISPLAY PANEL - 4 g Stick Label

perlips
labial hidratante con
perlas de luz y FPS 20

cy°

cy°zone
4 g e (.14 oz.)

INGREDIENTS AND APPEARANCE

CYZONE   CY PERLIPS LABIAL HIDRATANTE CON PERLAS DE LUZ Y FPS 20
octinoxate and oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-432
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.07 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.025 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CASTOR OIL (UNII: D5340Y2I9G)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
YELLOW WAX (UNII: 2ZA36H0S2V)
CANDELILLA WAX (UNII: WL0328HX19)
SHEA BUTTER (UNII: K49155WL9Y)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
GLYCERIN (UNII: PDC6A3C0OX)
OCTYLDODECANOL (UNII: 461N1O614Y)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
SUNFLOWER OIL (UNII: 3W1JG795YI)
SACCHARIN SODIUM DIHYDRATE (UNII: SB8ZUX40TY)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
PETROLATUM (UNII: 4T6H12BN9U)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CHOLESTEROL (UNII: 97C5T2UQ7J)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
CARNAUBA WAX (UNII: R12CBM0EIZ)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
ALUMINUM OXIDE (UNII: LMI26O6933)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 30 (UNII: 2S42T2808B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-432-01	4 g in 1 TUBE, WITH APPLICATOR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	07/13/2012

Labeler - Ventura Corporation LTD. (602751344)

Establishment
Name	Address	ID/FEI	Business Operations
Bel Star S.A. (Colombia)		880160197	MANUFACTURE(13537-432)

Establishment
Name	Address	ID/FEI	Business Operations
Yobel Supply Chain Management S.A. (Peru)		934116930	MANUFACTURE(13537-432)