Otc - Active Ingredient
Active Ingredient Section (Usrx Cool Mint Lip Balm)
Sunscreen Lip Balm Spf 30 Cool Mint Stick
FDA Label NDC 70809-1235
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Usrx for the product Sunscreen Lip Balm Spf 30 Cool Mint (NDC 70809-1235). 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, otc - keep out of reach of children, dosage & administration, warnings, otc - stop use, inactive ingredient, indications & usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Sunscreen
Active Ingredient Section (Usrx Cool Mint Lip Balm)
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed get medical help or contact a poison control center immediately.
Dosage & Administration
Directions • Apply liberally and generously 15 minutes before sun exposure. • Reapply after 40 minutes of swimming or sweating, immediately after towel drying, and at least every 2 hours. • Children under 6 months: Ask a doctor.
Sun protective 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 10 am to 2 pm. • Wear long-sleeve shirts, pants, hats, and sunglasses.
Warnings
For external use only
Otc - Stop Use
Stop use and ask a doctor if rash or irritation occurs
Inactive Ingredient
Beeswax, Octyldodecanol, Butyloctyl Salicylate, Simmondsia Chinensis (Jojoba) Seed Oil, Octyldodecyl Neopentanoate, Punica Granatum Sterols, Caprylic/Capric Triglyceride, Mentha Piperita (Peppermint) Oil, Tocopheryl Acetate, Hydrogenated Castor Oil, Ricinus Communis (Castor) Seed Oil, Sodium Hyaluronate, Flavor / Aroma, Limonene
Indications & Usage
When using this product keep out of eyes. Rinse with water
Package Label.Principal Display Panel
Active Ingredient Section (Usrx Cool Mint Lip Balm)
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