Lip Balm Sunscreen Spf 4
FDA Label NDC 0363-6050

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Walgreen Co for the product Lip Balm Sunscreen Spf 4 (NDC 0363-6050). 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 ingredients, purpose, uses, warnings, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Padimate O, 1.5%

Purpose

Sunscreen

Uses

  • Helps prevent sunburn

Warnings

Skin Cancer/Skin Aging Alert:  Spending time in the sun increases your risk of skin cancer and early skin aging.  This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

For external use only

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

Other Information

  • protect this product from excessive heat and direct sunlight

Inactive Ingredients

Petrolatum, paraffinum liquidum (mineral oil), ozokerite, octyldodecanol, phenyl methicone, flavor, arachidyl propionate, cera alba (beeswax), camphor, copernicia cerifera (carnauba) wax, isopropyl lanolate, isopropyl myristate, lanolin, paraffin, cetyl alcohol, saccharin, methylparaben, propylparaben, D&C red #6 (CI 15850), FD&C yellow #5 (CI 19140)

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