Karavita Face Essential with SPF 15

Dosage form: lotion
Ingredients: Octinoxate 7.5g in 59mL, Octisalate 3g in 59mL, Oxybenzone 5g in 59mL
Labeler: Kara Vita, Inc.
NDC Code: 68572-3004

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.

KARA VITA®
Face Essential
with SPF 15

Active Ingredients

Octinoxate (7.5%), Octisalate (3.0%), Oxybenzone (5.0%)

Warnings

External use only. Keep out of reach of children. Keep out of eyes. Rinse with warm water to remove.

Stop use and ask a doctor if

Rash or irritation develops and lasts.

Directions

Apply evenly before sun exposure and as needed. Children under 6 months of age, ask a doctor.

Manufactured for: Kara Vita®
St. Petersburg, FL • 727-456-7560
www.karavita.com

PRINCIPAL DISPLAY PANEL - 59 ml Label

KARA VITA®

Face Essential
with SPF 15

4

2 fl. oz. / 59ml

KARAVITA FACE ESSENTIAL WITH SPF 15 
octinoxate, octisalate, and oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68572-3004
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (Octinoxate) Octinoxate7.5 g  in 59 mL
Octisalate (Octisalate) Octisalate3 g  in 59 mL
Oxybenzone (Oxybenzone) Oxybenzone5 g  in 59 mL
Packaging
#Item CodePackage Description
1NDC:68572-3004-21 BOTTLE (BOTTLE) in 1 CARTON
159 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35201/01/2004
Labeler - Kara Vita, Inc. (140693388)
Establishment
NameAddressID/FEIOperations
Dermazone Solutions, LLC136116865MANUFACTURE

Revised: 01/2010
 
Kara Vita, Inc.

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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