CYZONE  SUN BY ME- octinoxate, oxybenzone, octisalate, and titanium dioxide lotion 
Ventura Corporation Limited

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.

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sun
by me
cy°zone

Drug Facts

Active IngredientsPurpose   
Octinoxate 7.5 %sunscreen
Octisalate 5.0 %sunscreen
Oxybenzone 5.0%sunscreen
Titanium dioxide 0.948%sunscreen

Uses

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

Other information

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

PRINCIPAL DISPLAY PANEL - 120 ml Bottle Label
CYZONE   SUN BY ME
octinoxate, oxybenzone, octisalate, and titanium dioxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-110
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.075 g  in 1 mL
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.05 g  in 1 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate0.05 g  in 1 mL
Titanium dioxide (UNII: 15FIX9V2JP) (Titanium dioxide - UNII:15FIX9V2JP) Titanium dioxide0.00948 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-110-131 in 1 CARTON
1NDC:13537-110-12120 mL in 1 BOTTLE
2NDC:13537-110-061 in 1 CARTON
2NDC:13537-110-055 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35204/22/2011
Labeler - Ventura Corporation Limited (602751344)
Establishment
NameAddressID/FEIBusiness Operations
BelStar, S.A.880160197MANUFACTURE

Revised: 11/2010
Document Id: 29f0150d-79e4-4d74-862e-352c0057e84d
Set id: b12a53cd-0c00-4acd-aad7-afb5ab6ffc23
Version: 1
Effective Time: 20101108
 
Ventura Corporation Limited