Otc - Active Ingredient
Drug Facts
Active Ingredients:
Avobenzone 2.0%
Octinoxate 6.5%
Octisalate 5.0%
Octocrylene 1.5%
Apple Lip Balm With Aloe Vera Stick
FDA Label NDC 30798-418
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Durvet, Inc. for the product Apple Lip Balm With Aloe Vera (NDC 30798-418). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - when using, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Sunscreen
Indications & Usage
Uses • Helps prevent sunburn
Warnings
Drug Facts (continued)
Warnings
•For external use only.
Otc - Do Not Use
•Do not use on damaged or broken skin
Otc - Ask Doctor
•Stop use and ask doctor if •rash occurs•
Otc - When Using
When using this product keep out of eyes. Rinse with water to remove.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions: •Apply liberally 15 mintues before sun exposure. •Use a water resistant sunscreen if swimming or sweating. •Reapply at least every 2 hours. •Children under 6 months of age: Ask a doctor. 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 value of 15 or higher and other
sun protection measures including: • limit time in the sun, especially from
10a.m. - 2p.m. • wear long sleeved shirts, pants, hats, and sunglasses.
Inactive Ingredient
Inactive Ingredients: Sunflower Oil*, Beeswax, Olive Oil*,
Flavor, Tocopherol, Hemp Seed Oil*, Rosemary Extract, Aloe
Extract, Soybean Oil, Canola Oil, Sunflower Seed Oil Glycerides.
*Organic Ingredient
Other Safety Information
Other Information: Protect this product from excessive heat and direct sun.
Package Label.Principal Display Panel
Apple Lip Balm
With Aloe Vera
Durvet®
www.durvet.com
Broad Spectrum SPF 15 Sunscreen
Net Wt. .15 oz NDC 30798-418-99
Dist. by: Durvet, Inc. Blue Springs, MO 64014
816-229-9101 lSS25XB08
RES
* Please review the disclaimer below.
