Cyzone description, usages, side effects, indications, overdosage, supplying and lots more!

Cyzone

Ventura Corporation Ltd.

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
cy° cy°zone better lips balm

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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

Octinoxate, Oxybenzone, and Zinc Oxide LIPSTICK

Product Information

Product Type Human otc drug label Item Code (Source) NDC:13537-300
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 70 mg
OXYBENZONE OXYBENZONE 20 mg
Zinc Oxide Zinc oxide 10 mg

Inactive Ingredients

Ingredient Name Strength
MEDIUM-CHAIN TRIGLYCERIDES
castor oil
OCTYLDODECANOL
CANDELILLA WAX
YELLOW WAX
carnauba wax
MICA
DIPALMITOYL HYDROXYPROLINE
GLYCERYL ISOSTEARATE
ISOSTEARYL ALCOHOL
GLYCERIN
SHEA BUTTER
BRAZIL NUT OIL
BABASSU OIL
.BETA.-SITOSTEROL
saccharin sodium
cetearyl ethylhexanoate
PROPYLPARABEN
MICROCRYSTALLINE WAX
BUTYLATED HYDROXYTOLUENE
AVOBENZONE
petrolatum
CETYL ALCOHOL
HYDROGENATED COCONUT OIL
OCTISALATE
CHOLESTEROL
OLEYL ALCOHOL
TRIETHOXYCAPRYLYLSILANE
DIMETHICONE
CETEARYL GLUCOSIDE
CETOSTEARYL ALCOHOL
titanium dioxide
D&c Red No. 21
D&C RED NO. 7
D&C RED NO. 27
FD&C RED NO. 40
ALUMINUM OXIDE
ferric oxide red
FERRIC OXIDE YELLOW
SILICON DIOXIDE
FD&C YELLOW NO. 5
talc
FERROSOFERRIC OXIDE
STANNIC OXIDE
PALMITIC ACID
METHYLPARABEN
BUTYLPARABEN

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:13537-300-02 4.5 in 1 TUBE
2 NDC:13537-300-01 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2011-02-28


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