FDA Label for Medicated Lip Balm
View Indications, Usage & Precautions
Medicated Lip Balm Product Label
The following document was submitted to the FDA by the labeler of this product Xtreme Tools International, Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredients
Dimethicone 2.0%
Oxybenzone 2.5%
2-Ethylhexyl Dimethyl PABA 6.6%
Purpose
Dimethicone 2.0% - Lip protectant
Oxybenzone 2.5%- Sunscreen
2-Ethylhexyl Dimethyl PABA 6.6%- Sunscreen
Uses
- Temporarily protects and relieve chapped or cracked lips
- Helps prevent sunburn
Warnings
Skin Cancer/Skin Aging Alert
Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.
For external use only
Otc - Do Not Use
Do not use on broken or damaged 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 swallowed, get medical help or contact a Poison Control Center right away.
Directions
- apply liberally 15 minutes before sun exposure
- reapply at least every 2 hours
- use a water resistant sunscreen if swimming or sweating
- children under 6 years of age: Ask a doctor
Inactive Ingredients
Prunus Arnygdalus Dulcis (Sweet Almond) Oil, Anthemis Nobilis Flower Extract, Hydrogenated Vegetable Oil, Beeswax, Shea Butter Ethyl Esters, Cocos Nucifera (Coconut) Oil, Argania Spinosa (Argan) Nut Oil, Tocopheryl Acetate, Organic flavors.
Other Information
- protect this product from excessive heat and direct sun.
Questions Or Comments?
Call 1-305-622-7474 Monday through Friday 9:00 AM to 5:00 PM
Package Label
5 gram in Jar ; NDC 74553-004-01
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