Petroleum-free Lip Balm Lipstick
FDA Label NDC 53329-092

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Medline Industries, Lp for the product Petroleum-free Lip Balm (NDC 53329-092). 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, keep out of reach of children., directions, inactive ingredients, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Octinoxate (2.0%), Oxybenzone (4.5%)

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 ben shown only to help prevent sunburn, not skin cancer or early skin aging.
    • For external use only.
    • Do not use on damaged or broken skin.
    • When using this product keep out of eyes. Rinse with water to remove.
    • Stop use and ask a doctor if rash occurs.

Keep Out Of Reach Of Children.

If swallowed, get medical help of contact a Poison Control Center right away.

Directions

  • apply liberally 15 minutes before sun exposure
  • use a water resistant sunscreen if swimming or sweating
  • reapply at least every 2 hours
  • children under 6 months: ask a doctor

Inactive Ingredients

Beeswax, Helianthus Annuus (Sunflower) Seed Oil, Ricinus Communis (Castor) Seed Oil, Lanolin, Cocos-Nucifera (Coconut) Oil, Flavor, Zea Mays (Corn) Oil (and) BHT, Tocopheryl Acetate, Melaleuca Alterifolia (Tea Tree) Leaf Oil.

Package/Label Principal Display Panel

NDC: 53329-092-83

Curad®

WE HELP HEAL

SPF 15

Sunscreen

CUR04015

Petroleum-Free Lip Balm

Moisturizing • Natural Beeswax

Mint Flavor

NET WT. .15 oz. (4.2g)

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