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

Karavita Face Essential with SPF 15 by

Drug Labeling and Warnings

Karavita Face Essential with SPF 15 by is a Otc medication manufactured, distributed, or labeled by Kara Vita, Inc., Dermazone Solutions, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	10/15/2015

Labeler - Kara Vita, Inc. (140693388)

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