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NDC 56152-5013-01 Herban Roots Sunscreen Broad Spectrum SPF 30 14.57 g/100mL Details
Herban Roots Sunscreen Broad Spectrum SPF 30 14.57 g/100mL
Herban Roots Sunscreen Broad Spectrum SPF 30 is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Cosmetic Enterprise Ltd. The primary component is ZINC OXIDE.
Product Information
| NDC | 56152-5013 |
|---|---|
| Product ID | 56152-5013_e90fb73e-f0d6-3ee3-e053-2a95a90a3268 |
| 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 | Herban Roots Sunscreen Broad Spectrum SPF 30 |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Zinc Oxide |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | CREAM |
| Route | TOPICAL |
| Active Ingredient Strength | 14.57 |
| Active Ingredient Units | g/100mL |
| Substance Name | ZINC OXIDE |
| Labeler Name | Cosmetic Enterprise Ltd |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | M020 |
| Listing Certified Through | 2023-12-31 |
Package
Package Images
NDC 56152-5013-01 (56152501301)
| NDC Package Code | 56152-5013-1 |
|---|---|
| Billing NDC | 56152501301 |
| Package | 118 mL in 1 TUBE (56152-5013-1) |
| Marketing Start Date | 2018-09-14 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL e90fb73e-f0d5-3ee3-e053-2a95a90a3268 Details
SPL UNCLASSIFIED SECTION
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Directions
- Apply liberally 15 minutes before sun exposure
- Reapply:
- after 40 minutes of swimming or sweating
- immediately after towel drying
- 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 of 15 or higher and other sun protection measures including:
- limited time in the sun, especially from 10 a.m. - 2 p.m.
- wear long-sleeve shirts, pants, hats, and sunglasses
- Children under 6 months: ask a doctor
SPL UNCLASSIFIED SECTION
PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
| HERBAN ROOTS SUNSCREEN BROAD SPECTRUM SPF 30
zinc oxide cream |
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| Labeler - Cosmetic Enterprise Ltd (017701475) |
Revised: 9/2022
Document Id: e90fb73e-f0d6-3ee3-e053-2a95a90a3268
Set id: e90fb73e-f0d5-3ee3-e053-2a95a90a3268
Version: 1
Effective Time: 20220919