ESIKA  NATURAL CARE- octinoxate and oxybenzone cream 
Ventura Corporation Ltd

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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Drug Facts

Active Ingredients Purpose
OCTINOXATE 7.5%Sunscreen
OXYBENZONE 4.5%Sunscreen

Uses

  • Helps prevent sunburn.

Warnings

Skin Cancer / Skin Aging Alert

  • Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

  • For external use only.

  • Do not use on damaged or broken skin.

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

  • Stop use and ask a doctor if rash occurs.

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

Directions

  • Apply liberally and evenly 15 minutes before sun exposure.
  • Reapply at least every 2 hours
  • Use a water resistant sunscreen if swimming or sweating.
  • Children under 6 months of age: Ask a doctor

Other information

  • Protect the product in this container from excessive heat and direct sun.

Inactive ingredients

AQUA (WATER), GLYCERYL STEARATE, CYCLOPENTASILOXANE, C12-15 ALKYL BENZOATE, PEG-100 STEARATE, CETYL ALCOHOL, DICAPRYLYL CARBONATE, PROPYLENE GLYCOL, GLYCERIN, PHENOXYETHANOL, CYCLOHEXASILOXANE, DIMETHICONE, METHYLPARABEN, CI 77891 (TITANIUM DIOXIDE ), PAPAIN, TRIETHANOLAMINE, PROPYLPARABEN, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, SODIUM LACTATE, CASTORYL MALEATE, PARFUM (FRAGRANCE), BUTYLENE GLYCOL, TETRASODIUM EDTA, CALCIUM PANTOTHENATE, ARCTOSTAPHYLOS UVA URSI LEAF EXTRACT, XANTHAN GUM, BUTYLPARABEN, ETHYLPARABEN, CAPRYLYL GLYCOL, ROSA MOSCHATA SEED OIL, UREA, MAGNESIUM LACTATE, ETHYLHEXYLGLYCERIN, POTASSIUM LACTATE, ISOBUTYLPARABEN, ALANINE, MAGNESIUM CHLORIDE, PROLINE, SERINE, SODIUM CITRATE, MOTHER OF PEARL EXTRACT.

Dist. by Ventura Corporation, Ltd. San
Juan, Puerto Rico 00926.

PRINCIPAL DISPLAY PANEL - 60 g Jar Label

60 g e (2.1 oz.)

naturalcare

rosa mosqueta
& concha de nácar

crema aclaradora facial FPS 15

Principal Display Panel - 60 g Jar Label
ESIKA   NATURAL CARE
octinoxate and oxybenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-152
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (Octinoxate) Octinoxate0.075 g  in 1 g
Oxybenzone (Oxybenzone) Oxybenzone0.045 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER 
GLYCERYL MONOSTEARATE 
CYCLOMETHICONE 5 
ALKYL (C12-15) BENZOATE 
PEG-100 STEARATE 
CETYL ALCOHOL 
DICAPRYLYL CARBONATE 
PROPYLENE GLYCOL 
GLYCERIN 
PHENOXYETHANOL 
CYCLOMETHICONE 6 
DIMETHICONE 
METHYLPARABEN 
TITANIUM DIOXIDE 
PAPAIN 
TROLAMINE 
PROPYLPARABEN 
SODIUM LACTATE 
BUTYLENE GLYCOL 
EDETATE SODIUM 
CALCIUM PANTOTHENATE 
ARCTOSTAPHYLOS UVA-URSI LEAF 
XANTHAN GUM 
BUTYLPARABEN 
ETHYLPARABEN 
CAPRYLYL GLYCOL 
ROSA MOSCHATA SEED OIL 
UREA 
ETHYLHEXYLGLYCERIN 
POTASSIUM LACTATE 
ISOBUTYLPARABEN 
ALANINE 
MAGNESIUM CHLORIDE 
PROLINE 
SERINE 
SODIUM CITRATE 
Packaging
#Item CodePackage Description
1NDC:13537-152-0160 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35201/24/2012
Labeler - Ventura Corporation Ltd (602751344)
Establishment
NameAddressID/FEIBusiness Operations
Bel Star S.A. (Colombia)880160197MANUFACTURE

Revised: 01/2012
Document Id: 6ff2751d-79a6-47ef-bba3-6bc6a476f406
Set id: 340d1267-0d2a-44fb-9ea7-304ab77bcc32
Version: 1
Effective Time: 20120126
 
Ventura Corporation Ltd