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Drug Facts
Blistex
FDA Label NDC 10157-9608
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 10157-9608). 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
Otc - Purpose
| Active ingredients | Purpose |
|---|---|
| Dimethicone 2.0% (w/w) | Lip protectant |
| Oxybenzone 2.5% (w/w) | Sunscreen |
| Padimate O 6.6% (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
For external use only
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, camphor, cetyl alcohol, cetyl palmitate, euphorbia cerifera (candelilla) wax, flavors, isopropyl myristate, isopropyl palmitate, isopropyl stearate, lanolin, lanolin oil, menthol, methylparaben, mineral oil, ozokerite, paraffin, petrolatum, polybutene, propylparaben, red 6 lake, theobroma cacao (cocoa) seed butter, titanium dioxide
Other Information
- protect the product in this container from excessive heat and direct sun
Principal Display Panel - 3 Cylinder Blister Pack
Blistex® MEDICATED LIP BALM
LIP PROTECTANT/SUNSCREEN
SPF 15
Blistex® MEDICATED LIP BALM
NET WT. .15 oz (4.25g)
SPF 15
Blistex® MEDICATED LIP BALM
©2012 Blistex Inc.
P.O. Box 5392, Oak Brook, IL
60522 C36186
23012TE
DO NOT USE IF SEAL IS MISSING.
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Principal Display Panel (3 Cylinder Blister Pack)
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