Active Ingredients
AVOBENZONE (2%)
HOMOSALATE (7.5%)
OCTISALATE (5%)
OCTOCRYLENE (2.5%)
OXYBENZONE (6%)
Aloe Up Medicated Lip Balm Lipstick
FDA Label NDC 61477-224
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Aloe Care International, Llc for the product Aloe Up Medicated Lip Balm (NDC 61477-224). 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 active ingredients, purpose, uses, directions, otc - keep out of reach of children, warnings, inactive ingredients, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
SUNSCREEN
Uses
HELPS PREVENT SUNBURN.
Directions
• Apply liberally 15 minutes before sun exposure
• Use a water resistant sunscreen if swimming or sweating
• Reapply at least every 2 hours
• Children under 6 months: Ask a doctor
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.
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
Do not use on damaged or broken skin
Stop use and ask a doctor if rash occurs
When using this product keep out of eyes. Rinse with water to remove.
Inactive Ingredients
Aloe Vera Leaf Extract, Camphor Powder, Canola Oil, Castor Oil, Cetyl Alcohol, Menthol, Ozokerite Wax, Petrolatum, Titanium
Dioxide, Tocopherol, Triethoxycaprylylsilane.
Other Information
• Protect this product from excessive heat and direct sun
Questions Or Comments?
Toll Free 800-950-2563 www.aloeup.com
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