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©2011 Blistex Inc.,
P.O. Box 5392,
Oak Brook, IL 60522-5392
Blistex
FDA Label NDC 10157-9539
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 10157-9539). 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, warnings, directions, inactive ingredients, principal display panel - 7 g container label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
| Active ingredients | Purpose |
|---|---|
| Lanolin 13 .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
Warnings
- Stop use if skin rash occurs
Directions
- apply liberally before sun exposure and as needed
Inactive Ingredients
aloe barbadensis leaf extract, camphor, cetyl alcohol, cocoyl hydrolyzed soy protein, euphorbia cerifera (candelilla) wax, fragrance, isostearoyl hydrolyzed collagen, menthol, microcrystalline wax, olea europaea (olive) fruit oil, petrolatum, saccharin, theobroma cacao (cocoa) seed butter, thymol, tocopheryl acetate, vanillin, vitis vinifera (grape) seed oil
Principal Display Panel - 7 G Container Label
NDC 10157-9539-1
Blistex®
LIP PROTECTANT/
SUNSCREEN
SPF
15
EUROPEAN FORMULA
LIP CONDITIONER™
Moisturizes & Protects For Healthy, Beautiful Lips
Enriched with Olive & Grapeseed Oils,
Vitamin E, Cocoa Butter, Lanolin and Collagen
NET WT. .25 oz (7g)
Principal Display Panel (7 g Container Label)
* Please review the disclaimer below.
