ESIKA Perfect Sun Kids

Dosage form: cream
Ingredients: ENSULIZOLE 0.03g in 1g, OCTINOXATE 0.075g in 1g, OCTISALATE 0.05g in 1g, OCTOCRYLENE 0.07g in 1g, OXYBENZONE 0.6g in 1g, TITANIUM DIOXIDE 0.0468g in 1g
Labeler: Ventura Corporation (San Juan, P.R)
NDC Code: 13537-363

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.

─ôsika
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
  • helps prevent sunburn
  • higher SPF gives more sunburn protection

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
  • Apply smoothly every morning before sun exposure and as needed.
  • Children under 6 months of age: ask a doctor.

Other information
  • High sun protection product.
  • Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risk of skin aging, skin cancer, and other harmful effects of the sun.

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

─ôsika

80 g e (2.8 oz.)

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 AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ENSULIZOLE (ENSULIZOLE) ENSULIZOLE0.03 g  in 1 g
OCTINOXATE (OCTINOXATE) OCTINOXATE0.075 g  in 1 g
OCTISALATE (OCTISALATE) OCTISALATE0.05 g  in 1 g
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE0.07 g  in 1 g
OXYBENZONE (OXYBENZONE) OXYBENZONE0.6 g  in 1 g
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE0.0468 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER 
DICAPRYLYL CARBONATE 
PHENETHYL BENZOATE 
ARGININE 
CYCLOMETHICONE 6 
CETOSTEARYL ALCOHOL 
SORBITAN MONOSTEARATE 
DIMETHICONE 
GLYCERYL MONOSTEARATE 
POTASSIUM CETYL PHOSPHATE 
PHENOXYETHANOL 
SILICON DIOXIDE 
DISODIUM LAURIMINODIPROPIONATE TOCOPHERYL PHOSPHATES 
METHYLPARABEN 
POLYOXYL 20 CETOSTEARYL ETHER 
PROPYLPARABEN 
XANTHAN GUM 
cyclomethicone 5 
BUTYLPARABEN 
ETHYLPARABEN 
ISOBUTYLPARABEN 
Packaging
#Item CodePackage Description
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/FEIOperations
Bel Star S.A. (Colombia)880160197MANUFACTURE

Revised: 05/2011
 
Ventura Corporation (San Juan, P.R)

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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