Lip Balm With Spf 15 Pina Colada Flavored Ointment
FDA Label NDC 72449-435
12 label sections · Submitted to the FDA by Ls Promotions Inc. · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Ls Promotions Inc. for the product Lip Balm With Spf 15 Pina Colada Flavored (NDC 72449-435). 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 ingredients, purpose, uses, warnings, stop use and ask a doctor, when using this product, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients
Octinoxate 7.5%
Oxybenzone 3.5%
Purpose
Sunscreen
Uses
Helps prevent sunburn
Warnings
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.
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 months of age: Ask a doctor
Sun Protection MeasuresSpending 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 sleeved shirts, pants, hats, and sunglasses
Inactive Ingredients:
Petrolatum, Ozokerite, Mineral Oil, Flavor, Microcrystalline Wax, Copernicia Cerifera (Carnauba) Wax, Lanolin, Paraffin, Saccharin, Glycine Soja (Soybean) Oil, Methylparaben, Propylparaben, Tocopherol, Aloe Barbadensis Leaf Extract.
Questions Or Comments?
Call weekdays from 9AM to 5PM EST at 631-231-2300.
Package Labeling:
Label6 (Label6)
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