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NDC 62032-0070-18 NU-DERM PHYSICAL UV 185 mg/g Details
NU-DERM PHYSICAL UV 185 mg/g
NU-DERM PHYSICAL UV is a TOPICAL LOTION in the HUMAN OTC DRUG category. It is labeled and distributed by Obagi Cosmeceuticals LLC. The primary component is ZINC OXIDE.
Product Information
| NDC | 62032-0070 |
|---|---|
| Product ID | 62032-070_2af9c0fa-9906-47c1-84af-3ed7c0a78cdc |
| 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 | NU-DERM PHYSICAL UV |
| Proprietary Name Suffix | BROAD SPECTRUM SPF 32 |
| Non-Proprietary Name | ZINC OXIDE |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | LOTION |
| Route | TOPICAL |
| Active Ingredient Strength | 185 |
| Active Ingredient Units | mg/g |
| Substance Name | ZINC OXIDE |
| Labeler Name | Obagi Cosmeceuticals LLC |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part352 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 62032-0070-18 (62032007018)
| NDC Package Code | 62032-070-18 |
|---|---|
| Billing NDC | 62032007018 |
| Package | 57 g in 1 BOTTLE, PLASTIC (62032-070-18) |
| Marketing Start Date | 2004-01-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 0960cb9d-413e-4eeb-83b8-135b75642f90 Details
Uses
- •
- helps prevent sunburn
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- 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
- •
- use a water resistant sunscreen if swimming or sweating
- •
- reapply at least every 2 hours
- •
- children under 6 months: 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-sleeved shirts, pants, hats, and sunglasses
Inactive ingredients
beeswax, butylene glycol, cetyl dimethicone, cetyl PEG/PPG-10/1 dimethicone, dimethicone, disodium EDTA, epilobium angustifolium flower/leaf/stem extract, ethylhexyl stearate, glycereth-26, hydrogenated castor oil, isopropyl palmitate, methylparaben, propylparaben, sodium chloride, tocopherol acetate, triethoxycaprylylsilane, water
Other information
SPL UNCLASSIFIED SECTION
PRINCIPAL DISPLAY PANEL - 57 g Bottle Label
INGREDIENTS AND APPEARANCE
| NU-DERM PHYSICAL UV
BROAD SPECTRUM SPF 32
zinc oxide lotion |
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| Labeler - Obagi Cosmeceuticals LLC (790553353) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Swiss- American CDMO, LLC | 080170933 | MANUFACTURE(62032-070) | |
Revised: 1/2019
Document Id: 2af9c0fa-9906-47c1-84af-3ed7c0a78cdc
Set id: 0960cb9d-413e-4eeb-83b8-135b75642f90
Version: 3
Effective Time: 20190117