Karavita Face Essential With Spf 15
FDA Label NDC 68572-3005

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Kara Vita, Inc. for the product Karavita Face Essential With Spf 15 (NDC 68572-3005). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredients, purpose, uses, warnings, otc - do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

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

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

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

Otc - Do Not Use

Do not use on damaged or broken skin

Otc - When Using

When using this product keep out of eyes. Rinse with water to remove.

Otc - Stop Use

Stop use and ask a doctor if rash occurs

Otc - Keep Out Of Reach Of Children

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

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)

Principal Display Panel (57 g Bottle Carton)

* Please review the disclaimer below.