Blistex
FDA Label NDC 10157-9826

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Blistex Inc. for the product Blistex (NDC 10157-9826). 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, skin cancer/skin aging alert, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

For external use only

Otc - Purpose

Dimethicone 2.0% (w/w)Lip protectant
Octinoxate 7.5% (w/w)Sunscreen
Oxybenzone 2.5% (w/w)Sunscreen

Uses

  • temporarily protects and helps relieve chapped or cracked lips
  • helps prevent sunburn

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.

Otc - Do Not Use

Do not use on damaged or broken skin

Otc - When Using

When using this product keep out of eyes. Rinse with water to remove.

Otc - Stop Use

Stop use and ask a doctor if rash occurs

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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

Inactive Ingredients

beeswax, euterpe oleracea (acai) fruit extract, flavor, helianthus annuus (sunflower) seed oil, hydrogenated vegetable oil, jojoba esters, lanolin alcohol, lycium barbarum (goji) fruit extract, microcrystalline wax, octyldodecanol, olea europaea (olive) fruit oil, ozokerite, petrolatum, phenoxyethanol, polybutene, ricinus communis (castor) seed oil, saccharin, saccharomyces/copper ferment, saccharomyces/magnesium ferment, saccharomyces/potassium ferment, saccharomyces/zinc ferment, sorbic acid, squalane, theobroma cacao (cocoa) seed butter, tocopheryl acetate, vitis vinifera (grape) seed oil

Other Information

  • protect the product from excessive heat and direct sun

Principal Display Panel - 4.25G Stick Carton

Exceptionally
Healthy Lips
Inside & Out

Blistex®

Principal Display Panel (4.25g Stick Carton)

Principal Display Panel (4.25g Stick Carton)

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