![CYZONE (OCTINOXATE, OXYBENZONE, OCTISALATE, AND TITANIUM DIOXIDE) LOTION [VENTURA CORPORATION LIMITED]](https://medic.hrt.org//dailymed/images/b12a53cd-0c00-4acd-aad7-afb5ab6ffc23/cyzone-01.jpg)
| NDC | 13537-110-05, 13537-110-06, 13537-110-12, 13537-110-13 |
| Set ID | b12a53cd-0c00-4acd-aad7-afb5ab6ffc23 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Ventura Corporation Limited |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART352 |
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
- Warnings
- Directions
- Other information
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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
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INGREDIENTS AND APPEARANCE
CYZONE SUN BY ME
octinoxate, oxybenzone, octisalate, and titanium dioxide lotionProduct 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
