KARAVITA FACE ESSENTIAL WITH SPF 15- oxybenzone, avobenzone, octinoxate, and octisalate 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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Karavita Face Essential with SPF 15

Drug Facts

Active ingredients

Benzophenone-3 6.0%
Butyl Methoxydibenzoylmethane 3.0%
Ethylhexyl Methoxycinnamate 7.5%
Ethylhexyl Salicylate 5.0%

Purpose

Sunscreen

Uses

Warnings

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 product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

Inactive ingredients

Purified Water, Potassium Cetyl Phosphate, Sorbitol, Dicapryl Maleate, Alcohol, Lecithin, Dimethicone, Cetyl Alcohol, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice, Carbomer, Methylparaben, Propylparaben, Triethanolamine

Manufactured by:
Dermazone Solutions, Inc.
2440 30th Avenue North
St. Petersburg, FL 33713 USA

Distributed by:
Kara Vita®
St. Petersburg, FL 33713

PRINCIPAL DISPLAY PANEL - 57 g Bottle Carton

KARA VITA

face
essential
with SPF15

4

Broad
Spectrum
Protection

WATER RESISTANT
(80 MINUTES)

Clinical Skin
Care with
Lyphazome®
Technology

Net Wt. 2 oz. (57 g)

PRINCIPAL DISPLAY PANEL - 57 g Bottle Carton
KARAVITA FACE ESSENTIAL WITH SPF 15 
oxybenzone, avobenzone, octinoxate, and octisalate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68572-3005
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE60 mg  in 1 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
SORBITOL (UNII: 506T60A25R)  
ALCOHOL (UNII: 3K9958V90M)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68572-3005-21 in 1 CARTON10/15/2015
157 g in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35210/15/2015
Labeler - Kara Vita, Inc. (140693388)
Establishment
NameAddressID/FEIBusiness Operations
Dermazone Solutions, LLC136116865MANUFACTURE(68572-3005)

Revised: 11/2018
Document Id: 24762826-ee69-4314-97c4-0b7cb49d6b81
Set id: 5899f72b-e5e4-4ea3-a51d-7231a4b5bd29
Version: 2
Effective Time: 20181119
 
Kara Vita, Inc.