CYZONE- octinoxate, oxybenzone, octisalate, and titanium dioxide lotion

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]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredients	Purpose
Octinoxate 7.5 %	sunscreen
Octisalate 5.0 %	sunscreen
Oxybenzone 5.0%	sunscreen
Titanium dioxide 0.948%	sunscreen

Uses

• Helps prevent sunburn.
• Higher SPF gives more sunburn protection.
• Provides moderate protection against sunburn.
• Retains SPF after 40 minutes of activity in the water.

Warnings

For external use only.

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

Stop use and ask a doctor if rash or irritation develops and lasts

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

Directions

• Apply liberally 20 minutes before sun exposure and as needed

Other information

• Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreen may reduce the risk of skin aging, skin cancer, and other harmful effects of the sun.

Inactive ingredients

Aqua (water),dicaprylyl carbonate, c12-15 alkyl benzoate, dimethicone, cetearyl alcohol, vp/eicosene copolymer, potassium cetyl phospate, trimethylsiloxysilicate, titanium dioxide, phenoxyethanol, isopropil myristate glyceryl stearate, panthenol, peg-100 stearate, methylparaben, ceteareth-20, xanthan gum, parfum (fragance), propylparaben, propylene glycol, polysorbate 40, ci77019(mica), silica, triethanolamine, methicone, acrylates/c10-30 alkyl acrylate crosspolymer, tetrasodium edta, daucuscarotasativa root extract(daucus carota sativa (carrot) root extract), aloe barbadensis leaf juice, butylparaben, ethylparaben, isobutylparaben, ci 77491(iron oxides), ci 19140 (yellow5), ci 14700 (red4), cocos nucifera (coconut) oil, gardenia tahitensis flower, gardenia tahitensis flower extract ci42090 (blue 1).

PRINCIPAL DISPLAY PANEL - 120 ml Bottle Label

15
FPS
golden bronze

120 ml e (4 fl oz.)

sun
by me

cy°zone

INGREDIENTS AND APPEARANCE

CYZONE   SUN BY ME
octinoxate, oxybenzone, octisalate, and titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-110
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.075 g  in 1 mL
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.05 g  in 1 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	0.05 g  in 1 mL
Titanium dioxide (UNII: 15FIX9V2JP) (Titanium dioxide - UNII:15FIX9V2JP)	Titanium dioxide	0.00948 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
dicaprylyl carbonate (UNII: 609A3V1SUA)
c12-15 alkyl benzoate (UNII: A9EJ3J61HQ)
dimethicone (UNII: 92RU3N3Y1O)
cetostearyl alcohol (UNII: 2DMT128M1S)
phenoxyethanol (UNII: HIE492ZZ3T)
isopropyl myristate (UNII: 0RE8K4LNJS)
glyceryl monostearate (UNII: 230OU9XXE4)
panthenol (UNII: WV9CM0O67Z)
polyoxyl 100 stearate (UNII: YD01N1999R)
methylparaben (UNII: A2I8C7HI9T)
polyoxyl 20 cetostearyl ether (UNII: YRC528SWUY)
xanthan gum (UNII: TTV12P4NEE)
propylparaben (UNII: Z8IX2SC1OH)
propylene glycol (UNII: 6DC9Q167V3)
polysorbate 40 (UNII: STI11B5A2X)
mica (UNII: V8A1AW0880)
silicon dioxide (UNII: ETJ7Z6XBU4)
trolamine (UNII: 9O3K93S3TK)
carbomer interpolymer type a (55000 cps) (UNII: 59TL3WG5CO)
edetate sodium (UNII: MP1J8420LU)
carrot (UNII: L56Z1JK48B)
aloe vera leaf (UNII: ZY81Z83H0X)
butylparaben (UNII: 3QPI1U3FV8)
ethylparaben (UNII: 14255EXE39)
isobutylparaben (UNII: 0QQJ25X58G)
ferric oxide red (UNII: 1K09F3G675)
FD&C yellow no. 5 (UNII: I753WB2F1M)
FD&C red no. 4 (UNII: X3W0AM1JLX)
coconut oil (UNII: Q9L0O73W7L)
FD&C blue no. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-110-13	1 in 1 CARTON
1	NDC: 13537-110-12	120 mL in 1 BOTTLE
2	NDC: 13537-110-06	1 in 1 CARTON
2	NDC: 13537-110-05	5 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	04/22/2011

Labeler - Ventura Corporation Limited (602751344)

Establishment
Name	Address	ID/FEI	Business Operations
BelStar, S.A.		880160197	MANUFACTURE