Hydrating Sheer Lip Balm Trio The Neutrals Kit
FDA Label NDC 49358-002

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Mdsolarsciences for the product Hydrating Sheer Lip Balm Trio The Neutrals (NDC 49358-002). 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 other, otc - purpose, uses, warnings, otc - do not use, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Otc - Purpose

Active ingredientsPurpose
Avobenzone 3%Sunscreen
Octisalate 5%Sunscreen
Homosalate 10%Sunscreen

Uses

  • 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.

Directions

  • Apply liberally 15 minutes before sun exposure
  • Reapply:
    • use a water resistant sunscreen if swimming or sweating
    • at least every 2 hours
    • Children under 6 months: Ask a doctor
    • Sun Protection Measures :Spending time in the sun increases your risk of skin cancer and early skin aging.
      To decrease the risk, regularly use a sunscreen with Broad Spectrum SPF of 15 or higher and other sun protection measures including:
      • Limit time in the sun, especially from 10a.m.- 2p.m.
      • Wear long-sleeved shirts, pants, hats and sunglasses

Other Information

  • Protect the product in this container from excessive heat and direct sunlight
  • You may report serious adverse reactions to: Report Reaction, LLC., PO Box 22, Plainsboro, NJ 08536-0222

* Please review the disclaimer below.