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Name:All Day Sunscreen With Spf 30
Manufacturer:Kara Vita, Inc.
Category:Over-the-counter (OTC) Marketed Drugs


KARA VITA® ALL DAY SUNCARE SPF 30

ALL DAY SUNSCREEN WITH SPF 30 - oxybenzone, octinoxate, octisalate and homosalate lotion 
Kara Vita, Inc.

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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KARA VITA®
ALL DAY SUNCARE
SPF 30

Drug Facts

Active ingredients Purpose
Homosalate 5.0%,
Octinoxate 7.5%,
Octisalate 5.0%,
Oxybenzone 5.0% Sunscreen

Uses

  • Helps prevent sunburn.
  • Higher SPF gives more sunburn protection.
  • Retains SPF after 80 minutes of activity in the water, sweating, or perspiring.

Warnings

  • External use only.
  • Keep out of reach of children.

When using this product

  • 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.

Inactive ingredients

Deionized Water, Sorbitol, Dicaprylyl Maleate, Alcohol, Lecithin, DEA-Cetyl Phosphate, Aloe Barbadensis Leaf Juice, Dimethicone, Cetyl Alcohol, Carbomer, Methylparaben, Propylparaben, Triethanolamine, Tocopheryl Acetate.

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

Made in U.S.A.

PRINCIPAL DISPLAY PANEL - 118 ml carton

KARA VITA®

All Day Suncare
SPF 30

4 fl. oz. / 118ml

Principal Display Panel - 118 ml carton

ALL DAY SUNSCREEN WITH SPF 30 
oxybenzone, octinoxate, octisalate, and homosalate lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68572-6005
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Oxybenzone (Oxybenzone) Oxybenzone 8.9 g  in 118 mL
Octinoxate (Octinoxate) Octinoxate 8.9 g  in 118 mL
Octisalate (Octisalate) Octisalate 5.9 g  in 118 mL
Homosalate (Homosalate) Homosalate 5.9 g  in 118 mL
Product Characteristics
Color WHITE Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68572-6005-4 1 BOTTLE ( BOTTLE) in 1 CARTON contains a BOTTLE
1 59 mL in 1 BOTTLE This package is contained within the CARTON (68572-6005-4)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part352 01/01/2004

Labeler - Kara Vita, Inc. (140693388)
Establishment
Name Address ID/FEI Operations
Dermazone Solutions, LLC 136116865 MANUFACTURE

Revised: 01/2010 Kara Vita, Inc.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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