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NDC 10157-1170-01 Deep Renewal Broad Spectrum 3; 2; 9; 4.4 g/100g; g/100g; g/100g; g/100g Details
Deep Renewal Broad Spectrum 3; 2; 9; 4.4 g/100g; g/100g; g/100g; g/100g
Deep Renewal Broad Spectrum 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 | 10157-1170 |
|---|---|
| Product ID | 10157-1170_b82f3bc5-e80d-41e2-9c47-33cd74655829 |
| 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 | Deep Renewal Broad Spectrum |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | dimethicone, avobenzone, homosalate, and octisalate |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | STICK |
| Route | TOPICAL |
| Active Ingredient Strength | 3; 2; 9; 4.4 |
| 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 | part347 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 10157-1170-01 (10157117001)
| NDC Package Code | 10157-1170-1 |
|---|---|
| Billing NDC | 10157117001 |
| Package | 1 CYLINDER in 1 BLISTER PACK (10157-1170-1) / 3.69 g in 1 CYLINDER |
| Marketing Start Date | 2020-09-09 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 11c0e084-dc40-4969-a176-3af4116d6f27 Details
SPL UNCLASSIFIED SECTION
Warnings
Directions
- apply liberally 15 minutes before sun exposure
- reapply at least every 2 hours
- use a water resistant sunscreen if swimming or sweating
-
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
- children under 6 months of age: Ask a doctor.
Inactive ingredients
atelocollagen, beeswax, butylene glycol, dipalmitoyl hydroxyproline, ethylhexyl palmitate, flavors, jojoba esters, lanolin alcohol, microcrystalline wax, octyldodecanol, pentaerythrityl tetraisostearate, pentylene glycol, petrolatum, phenoxyethanol, polybutene, ricinus communis (castor) seed oil, saccharin, silica, silica dimethyl silylate, sodium chondroitin sulfate, sodium hyaluronate, sorbic acid, squalane, tetrahexyldecyl ascorbate, tocopheryl acetate, ubiquinone
PRINCIPAL DISPLAY PANEL - 3.69 g Cylinder Blister Pack
INGREDIENTS AND APPEARANCE
| DEEP RENEWAL BROAD SPECTRUM
dimethicone, avobenzone, homosalate, and octisalate stick |
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| Labeler - Blistex Inc (005126354) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Blistex Inc | 005126354 | MANUFACTURE(10157-1170) | |
Revised: 9/2020
Document Id: b82f3bc5-e80d-41e2-9c47-33cd74655829
Set id: 11c0e084-dc40-4969-a176-3af4116d6f27
Version: 1
Effective Time: 20200911