Forever Sun Lips
FDA Label NDC 11697-462

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 Vera Of America, Inc. for the product Forever Sun Lips (NDC 11697-462). 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, uses, warnings, otc - do not use, directions, inactive ingredients, other information, questions or comments?, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Otc - Active Ingredient

 Active Ingredients Purpose
 Avobenzone 3.0%.................. Sunscreen
 Homosalate 10.0%................ Sunscreen
 Octisalate 5.0%..................... Sunscreen
 Octocrylene 2.79%................ Sunscreen
 Petrolatum 38%.................... Lip Protectant

Uses

  • helps prevent and temporarily protects chapped or cracked lips
  • helps prevent and protect from the drying effects of wind and cold weather
  • helps prevent sunburn
  • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

For external use only

Otc - Do Not Use

Do not use on damaged and broken skin

Directions

  • apply liberally 15 minutes before sun exposure
  • reapply:
  •   after 80 minutes of swimming or sweating
  •   immediately after towel drying
  •   at least every 2 hours
  • Sun Protection 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 of 15 or higher and other sun protection measures including:

    •   limit time in the sun, especially from 10 a.m. - 2 p.m.
    •   wear long-sleeve shirts, pants, hats and sunglasses
    • children under 6 months: Ask a doctor

Inactive Ingredients

glycine soja (soybean) oil, ozokerite, butyloctyl salicylate, flavor, beeswax, ethylhexyl hydroxystearate, euphorbia cerifera (candelilla) wax, simmondsia chinensis (jojoba) seed oil, copernicia cerifera (carnauba) wax, menthol, menthyl lactate, aloe barbadensis leaf extract, allantoin

Other Information

  • protect this product from excessive heat and direct sun

Questions Or Comments?

Call 1-888-440-2563

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