ESIKA  PERFECT SUN KIDS- ensulizole, octinoxate, octisalate, octocrylene, oxybenzone, and titanium dioxide cream 
Ventura Corporation (San Juan, P.R)

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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ēsika
Perfect
sun
kids

Drug Facts

Active Ingredients

Ensulizole (3%), Octinoxate (7.5%), Octisalate (5%), Octocrylene (7%), Oxybenzone (6%),Titanium Dioxide (4.68%)

Purpose

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 and 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, vp/eicosene copolymer, phenethyl benzoate, arginine, cyclohexasiloxane, cetearyl alcohol, sorbitan stearate, dimethicone, glyceryl stearate, potassium cetyl phosphate, phenoxyethanol, trimethylsiloxysilicate, silica, disodium lauriminodipropionate tocopheryl phosphates, methyl methacrylate crosspolymer, methicone, methylparaben, ceteareth-20, propylparaben, xanthan gum, parfum (fragrance), cyclopentasiloxane, butylparaben, ethylparaben, isobutylparaben.

PRINCIPAL DISPLAY PANEL - 82 g Bottle Label

UVB SPF
50
High Protection
UVA

Perfect
sun
kids

protector against solar
rays for children, face and
body SPF 50

ēsika

80 g e (2.8 oz.)

PRINCIPAL DISPLAY PANEL - 82 g Bottle Label
ESIKA   PERFECT SUN KIDS
ensulizole, octinoxate, octisalate, octocrylene, oxybenzone, and titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-363
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE0.03 g  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.075 g  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE0.05 g  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE0.07 g  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.6 g  in 1 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.0468 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
PHENETHYL BENZOATE (UNII: 0C143929GK)  
ARGININE (UNII: 94ZLA3W45F)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
DISODIUM LAURIMINODIPROPIONATE TOCOPHERYL PHOSPHATES (UNII: 0K5Y9U1P6M)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
XANTHAN GUM (UNII: TTV12P4NEE)  
cyclomethicone 5 (UNII: 0THT5PCI0R)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
ETHYLPARABEN (UNII: 14255EXE39)  
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-363-0180 g in 1 BOTTLE
2NDC:13537-363-021 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35205/30/2011
Labeler - Ventura Corporation (San Juan, P.R) (602751344)
Establishment
NameAddressID/FEIBusiness Operations
Bel Star S.A. (Colombia)880160197MANUFACTURE

Revised: 5/2011
Document Id: cb0de263-166f-4688-a85d-8f7f1418cf95
Set id: 9163b23a-db5b-4881-9ecb-5819b60b2464
Version: 1
Effective Time: 20110527
 
Ventura Corporation (San Juan, P.R)