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NDC 71398-0014-01 Even Tone Mineral Sunscreen Broad Spectrum SPF 36 Medium - Dark 47.43; 87.048 mg/mL; mg/mL Details
Even Tone Mineral Sunscreen Broad Spectrum SPF 36 Medium - Dark 47.43; 87.048 mg/mL; mg/mL
Even Tone Mineral Sunscreen Broad Spectrum SPF 36 Medium - Dark is a TOPICAL LOTION in the HUMAN OTC DRUG category. It is labeled and distributed by SENT�, Inc.. The primary component is TITANIUM DIOXIDE; ZINC OXIDE.
Product Information
| NDC | 71398-0014 |
|---|---|
| Product ID | 71398-014_f76262f7-e65b-4732-bd8b-7be0451f772a |
| 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 | Even Tone Mineral Sunscreen Broad Spectrum SPF 36 Medium - Dark |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Titanium Dioxide and Zinc Oxide |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | LOTION |
| Route | TOPICAL |
| Active Ingredient Strength | 47.43; 87.048 |
| Active Ingredient Units | mg/mL; mg/mL |
| Substance Name | TITANIUM DIOXIDE; ZINC OXIDE |
| Labeler Name | SENT�, Inc. |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part352 |
| Listing Certified Through | 2023-12-31 |
Package
Package Images
NDC 71398-0014-01 (71398001401)
| NDC Package Code | 71398-014-01 |
|---|---|
| Billing NDC | 71398001401 |
| Package | 1 TUBE in 1 CARTON (71398-014-01) / 50 mL in 1 TUBE |
| Marketing Start Date | 2022-06-10 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL aedde765-931f-430e-9fc3-d87bde2b78cd Details
SPL UNCLASSIFIED SECTION
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
- 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- sleeved shirts, pants, hats, and sunglasses.
- Children under 6 months of age: Ask a doctor
Inactive ingredients
Water (Aqua), Dimethicone, Cyclopentasiloxane, PEG-10 Dimethicone, Pentylene Glycol, Hexyl Laurate, Polyglyceryl-4 Isostearate, Sodium Chloride, Heparan Sulfate, Glycerin, Fructose, Tocopheryl Acetate, Tocopherol, Withania Somnifera Root Extract, Iron Oxides (CI 77491, CI 77492, CI 77499), Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Dimethicone/Polyceryin-3 Crosspolymer, Stearic Acid, Alumina, Sodium Citrate, Dimethicone/Vinyl Dimethicone Crosspolymer, PEG/PPG-18/18 Dimethicone, Triethoxycaprylylsilane, Phenoxyethanol, Ethylhexylglycerin.
PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton
INGREDIENTS AND APPEARANCE
| EVEN TONE MINERAL SUNSCREEN BROAD SPECTRUM SPF 36 MEDIUM - DARK
titanium dioxide and zinc oxide lotion |
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| Labeler - SENTÉ, Inc. (079245446) |
Revised: 4/2022
Document Id: f76262f7-e65b-4732-bd8b-7be0451f772a
Set id: aedde765-931f-430e-9fc3-d87bde2b78cd
Version: 1
Effective Time: 20220428