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NDC 10157-1171-03 Blistex 3; 2; 15; 5 g/100g; g/100g; g/100g; g/100g Details
Blistex 3; 2; 15; 5 g/100g; g/100g; g/100g; g/100g
Blistex is a TOPICAL STICK in the HUMAN OTC DRUG category. It is labeled and distributed by Blistex Inc.. The primary component is AVOBENZONE; DIMETHICONE; HOMOSALATE; OCTISALATE.
Product Information
| NDC | 10157-1171 |
|---|---|
| Product ID | 10157-1171_7f00e804-2e2b-4dbf-8ceb-9e526785046a |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | Blistex |
| Proprietary Name Suffix | Five Star Lip Protection Broad Spectrum |
| Non-Proprietary Name | Homosalate, Octisalate, Avobenzone, and Dimethicone |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | STICK |
| Route | TOPICAL |
| Active Ingredient Strength | 3; 2; 15; 5 |
| Active Ingredient Units | g/100g; g/100g; g/100g; g/100g |
| Substance Name | AVOBENZONE; DIMETHICONE; HOMOSALATE; OCTISALATE |
| Labeler Name | Blistex Inc. |
| Pharmaceutical Class | Skin Barrier Activity [PE] |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part352 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 10157-1171-03 (10157117103)
| NDC Package Code | 10157-1171-3 |
|---|---|
| Billing NDC | 10157117103 |
| Package | 3 CYLINDER in 1 BLISTER PACK (10157-1171-3) / 4.25 g in 1 CYLINDER |
| Marketing Start Date | 2020-08-22 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 47b57317-7df5-442e-a3a4-1d44fe278ac6 Details
SPL UNCLASSIFIED SECTION
Uses
- temporarily protects and helps relieve chapped or cracked lips
- helps prevent sunburn
- if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun
Warnings
Directions
- apply liberally 15 minutes before sun exposure
- reapply:
- after 80 minutes of swimming or sweating
- immediately after towel drying
- at least every 2 hours
- children under 6 months of age: Ask a doctor
-
Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
- limit time in the sun, especially from 10 a.m.-2 p.m.
- wear long sleeve shirts, pants, hats, and sunglasses
Inactive ingredients
bis-diglyceryl polyacyladipate-2, bis-stearyl dimethicone, butyloctyl salicylate, C12-15 alkyl benzoate, calendula officinalis extract, caprylic/capric triglyceride, carthamus tinctorius (safflower) seed oil, cetyl dimethicone, citric acid, euphorbia cerifera (candelilla) wax, flavor, microcrystalline wax, myristyl myristate, octyldodecanol, oryzanol, ozokerite, panthenol, phenoxyethanol, sorbic acid, stearyl behenate, sucralose, tetrahexyldecyl ascorbate, tocopheryl acetate, triticum vulgare (wheat) germ oil
PRINCIPAL DISPLAY PANEL - 4.25 g Cylinder Blister Pack
INGREDIENTS AND APPEARANCE
| BLISTEX
FIVE STAR LIP PROTECTION BROAD SPECTRUM
homosalate, octisalate, avobenzone, and dimethicone stick |
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| Labeler - Blistex Inc. (005126354) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Blistex Inc. | 005126354 | MANUFACTURE(10157-1171) | |
Revised: 8/2020
Document Id: 7f00e804-2e2b-4dbf-8ceb-9e526785046a
Set id: 47b57317-7df5-442e-a3a4-1d44fe278ac6
Version: 1
Effective Time: 20200825