FDA Label for Petroleum-free Lip Balm

View Indications, Usage & Precautions

Petroleum-free Lip Balm Product Label

The following document was submitted to the FDA by the labeler of this product Medline Industries, Lp. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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)


* Please review the disclaimer below.