Lip Balm
FDA Label NDC 49852-202

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Tri-coastal Design Company Inc. for the product Lip Balm (NDC 49852-202). 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 ingredient, purpose, uses, warnings, directions, inactive ingredients, package label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Octyl Methoxycinnamate 6%

Oxybenzone 6%

Dimethicone 1%



Purpose

Sunscreen
Skin Protectant

Uses

  • Helps prevent sunburn
  • Temporarily protects and relieves chapped lips

Warnings

  • Keep out of eyes. Stop use if rash or irritation occurs. Keep out of reach of children. For external use only.

Directions

  • Apply liberally before sun exposure and as needed.

Inactive Ingredients

BHA, BHT, Caprylic/Capric Triglyceride, Cera Microcristallina, Flavor, Lanolin, Mineral Oil (Paraffinum Liquidum), Ozokerite, Petrolatum, Phenyl Trimethicone, Polyethylene, Propylparaben, PVP/Eicosene Copolymer, Tocopheryl Acetate

Package Label

Package Label

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