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NDC 62032-0200-01 NU-DERM HEALTHY SKIN PROTECTION 75; 90 mg/mL; mg/mL Details
NU-DERM HEALTHY SKIN PROTECTION 75; 90 mg/mL; mg/mL
NU-DERM HEALTHY SKIN PROTECTION is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by OBAGI COSMECEUTICAL LLC. The primary component is OCTINOXATE; ZINC OXIDE.
Product Information
| NDC | 62032-0200 |
|---|---|
| Product ID | 62032-200_01f78b31-3956-4757-baf7-caaba26aeea1 |
| 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 HEALTHY SKIN PROTECTION |
| Proprietary Name Suffix | SPF 35 |
| Non-Proprietary Name | OCTINOXATE and ZINC OXIDE |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | CREAM |
| Route | TOPICAL |
| Active Ingredient Strength | 75; 90 |
| Active Ingredient Units | mg/mL; mg/mL |
| Substance Name | OCTINOXATE; ZINC OXIDE |
| Labeler Name | OBAGI COSMECEUTICAL 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 62032-0200-01 (62032020001)
| NDC Package Code | 62032-200-01 |
|---|---|
| Billing NDC | 62032020001 |
| Package | 1 BOTTLE, PLASTIC in 1 CARTON (62032-200-01) / 85 mL in 1 BOTTLE, PLASTIC |
| Marketing Start Date | 2020-04-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL cfb6a918-1403-4cf2-86d8-d66dd764bb6c Details
Uses
- 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
- use a water resistant sunscreen if swimming or sweating
- reapply at least every 2 hours
- 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
- children under 6 months: Ask a doctor
Other information
Inactive ingredients
butylparaben, cetearyl alcohol, citric acid, C13-14 isoparaffin, DEA-cetyl phosphate, disodium EDTA, ethylhexyl stearate, ethylparaben, isobutylparaben, isopropyl palmitate, laureth-7, methylparaben, phenoxyethanol, polyacrylamide, polyether-1, polysorbate 60, propylparaben, sodium hydroxide, triethoxycaprylylsilane, water (aqua)
PRINCIPAL DISPLAY PANEL - 85 g Bottle Label
INGREDIENTS AND APPEARANCE
| NU-DERM HEALTHY SKIN PROTECTION
SPF 35
octinoxate and zinc oxide cream |
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| Labeler - OBAGI COSMECEUTICAL LLC (790553353) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Swiss-American CDMO, LLC | 080170933 | MANUFACTURE(62032-200) | |
Revised: 9/2019
Document Id: 01f78b31-3956-4757-baf7-caaba26aeea1
Set id: cfb6a918-1403-4cf2-86d8-d66dd764bb6c
Version: 5
Effective Time: 20190903