Wellcare Sunstick Lip Balm Stick
FDA Label NDC 83149-000
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bamko, Llc for the product Wellcare Sunstick Lip Balm (NDC 83149-000). 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 drug facts, active ingredient, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
(Sunscreen Stick)
Avobenzone 2.5mg
Octyl Methoxycinnamate 7.5mg
Octocrylene 10mg
OctyI Salicylate 5mg
(Lip Balm)
Avobenzone 0. 5mg.
Octyl Methoxycinnamate 5mg
Octocrylene 3
OctyI Salicylate 2.2mg
Purpose
Sunscreen
Uses
Helps prevent sunburn.
Warnings
For external use ony.
Do Not Use
on damaged or broken skin.
When Using This Product
keep out of eyes, Rinse with water to remove.
Stop Use And Ask A Doctor
if rash occurs.
Keep Out Of Reach Of Children.
If product is swallowed, get medical help or contact a Poison Control Center righaway.
Directions
- Apply liberally 15 minutes before sunexposure.
- Use a water resistant sunscreen if swimming or sweating.
- Reapply at least every 2 hours.
- Children under 6 months: Ask a doctor
Other Information
Protect this product from excessive heat and direct sunlight.
Inactive Ingredients
Alpha-Tocopherol Acetate, Bis-Diglyceryl Polyacyladipate-2, Coconut Oil, Ethylhexyl Palmitate, Hydrogenated Soybean Oil, Microcrystalline Wax, Polyisobutylene(2300 MW), Olive Oil, Silicon Dioxide, Stevioside, Synthetic Wax (1200 MW).
Alpha-Tocopherol Acetate, Bis-Diglyceryl Polyacyladipate-2, Coconut Oil, Ethylhexyl Palmitate, Fragrance (3-(3,4-Methylenedioxyphenyl)-2-methylpropanal, Ethyl vanillin, Propylene glycol, Vanillin), Hydrogenated Soybean Oil, Microcrystalline Wax, Olive Oil, Polyisobutylene(2300 MW), Stevioside, Synthetic Wax (1200 MW).
Wellcare Sunstick - Lip Balm, 0.14Oz/4G (83149-000-00)
Label (Label)
Wellcare Sunstick - Sunscreen Stick, 0.07Oz/2G (83149-001-00)
P1l (Photo1)
P2l (Photo2)
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