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Distributed by
Cyberderm Laboratories, Inc.
650-1600 Carling Avenue
Ottawa, ON K1Z 1G3
Made in Canada
Ava Isa Sun Lip Sun Whip Cream
FDA Label NDC 71644-009
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cyberderm Laboratories Inc. for the product Ava Isa Sun Lip Sun Whip (NDC 71644-009). 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, otc - active ingredient, otc - purpose, indications & usage, 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
Otc - Active Ingredient
Active ingredient
Zinc Oxide* 20%
Otc - Purpose
Purpose
Sunscreen
Indications & Usage
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
Warnings
For external use only.
Otc - Do Not Use
Do not use on damaged or broken skin.
Otc - When Using
When using this productkeep out of eyes. Rinse with water to remove.
Otc - Stop Use
Stop use and ask a doctor ifrash occurs.
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
- Adults and children over 6 months of age
- Apply liberally to face and body 15 minutes before sun exposure
- Reapply at least every 2 hours
- Use a water-resistant sunscreen if swimming or sweating
- 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 10am - 2pm
- Wear long-sleeved shirts, pants, hats and sunglasses
- Children under 6 months of age: ask a doctor
Storage And Handling
Other information
- Protect this product from excessive heat and direct sun
Inactive Ingredient
Inactive ingredients
Caprylic/capric triglyceride, Butyrospermum Parkii (Shea) Butter, Myrica Cerifera (Bayberry) Fruit Wax, Vegetable oil, Hydrogenated vegetable oil, Euphorbia Cerifera (Candelilla) Wax, Lauryl laurate, Polyhydroxystearic Acid, Behenyl behenate, Polyglyceryl-10 stearate, Sodium stearoyl lactylate, Glyceryl Isostearate, d-alpha Tocopherol.
Otc - Questions
Questions?
718-481-2628. Monday-Friday, 9 am - 5 pm
Package Label.Principal Display Panel
AVA ISA
Sun Lip
Sun Whip®
Clear Sunshine
melt-on-contact all mineral lip balm
SPF 15 Broad Spectrum
UVA/UVB Protection
made with 20% zinc oxide
10 ml (.33 fl oz)
NPN 80097041
* Please review the disclaimer below.
