Blistex
FDA Label NDC 10157-9848

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 10157-9848). 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, otc - stop use, directions, inactive ingredients, active ingredients, purpose, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Other

→ Otc - Purpose

→ Uses

→ Otc - Stop Use

→ Directions

→ Inactive Ingredients

→ Active Ingredients

→ Purpose

→ Principal Display Panel - Kit Package

Other

Drug Facts - Revive

Drug Facts - Restore

Otc - Purpose

Active ingredients	Purpose
Dimethicone 1.0%(w/w)	Skin protectant
Octinoxate 7.5%(w/w)	Sunscreen
Oxybenzone 2.5%(w/w)	Sunscreen

Uses

temporarily protects and helps relieve chapped or cracked lips
helps protect lips from the drying effects of wind and cold weather
helps prevent sunburn

temporarily protects and helps relieve chapped or cracked lips
helps protect lips from the drying effects of wind and cold weather

Otc - Stop Use

Stop use if skin rash occurs

Directions

apply liberally before sun exposure and as needed
children under six months of age:
ask a doctor

apply as needed

Inactive Ingredients

acer saccharum (sugar maple) extract, aloe barbadensis leaf extract, beeswax, bis-diglyceryl polyacyladipate-2, butyrospermum parkii (shea butter), C10-30 cholesterol/lanosterol esters, caprylic/capric triglyceride, cholesteryl/behenyl/octyldodecyl lauroyl glutamate, citrus aurantium dulcis (orange) fruit extract, citrus medica limonum (lemon) extract, flavors, menthol, microcrystalline wax, myristyl myristate, octyldodecanol, phenoxyethanol, polybutene, purified water, ricinus communis (castor) seed oil, saccharin, saccharum officinarum (sugar cane) extract, vaccinium myrtillus (bilberry) extract

beeswax, bis-diglyceryl polyacyladipate-2, brassica campestris/aleurites fordi oil copolymer, C10-30 cholesterol/lanosterol esters, flavors, hydrogenated polyisobutene, jojoba esters, microcrystalline wax, myristyl myristate, octyldodecanol, phenoxyethanol, polybutene, saccharin, simmondsia chinensis (jojoba) seed oil, squalane, theobroma cacao (cocoa) seed butter, tocopheryl acetate