Karavita Face Essential With Spf 15 (Oxybenzone, Avobenzone, Octinoxate, And Octisalate) Lotion [Kara Vita, Inc.] -

KARAVITA FACE ESSENTIAL WITH SPF 15 (OXYBENZONE, AVOBENZONE, OCTINOXATE, AND OCTISALATE) LOTION [KARA VITA, INC.]
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NDC	68572-3005-2
Set ID	5899f72b-e5e4-4ea3-a51d-7231a4b5bd29
Category	HUMAN OTC DRUG LABEL
Packager	Kara Vita, Inc.
Generic Name
Product Class
Product Number
Application Number	PART352

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SPL UNCLASSIFIED SECTION

Drug Facts
Active ingredients

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

Sunscreen
Uses
- helps prevent sunburn
- if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun
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
- apply liberally 15 minutes before sun exposure
- reapply:
  - after 80 minutes of swimming or sweating
  - immediately after towel drying
  - at least every 2 hours
- Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:
  - limit time in the sun, especially from 10 a.m. - 2 p.m.
  - wear long-sleeve shirts, pants, hats, and sunglasses
- children under 6 months: Ask a doctor
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
SPL UNCLASSIFIED SECTION

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)

INGREDIENTS AND APPEARANCE

KARAVITA FACE ESSENTIAL WITH SPF 15
oxybenzone, avobenzone, octinoxate, and octisalate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68572-3005
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	60 mg in 1 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:68572-3005-2	1 in 1 CARTON	10/15/2015
1		57 g in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	10/15/2015

Labeler - Kara Vita, Inc. (140693388)

Name	Address	ID/FEI	Business Operations
Establishment
Dermazone Solutions, LLC		136116865	MANUFACTURE(68572-3005)

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Medic

KARAVITA FACE ESSENTIAL WITH SPF 15 (OXYBENZONE, AVOBENZONE, OCTINOXATE, AND OCTISALATE) LOTION [KARA VITA, INC.]

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