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NDC 81521-0001-01 Derm Institute Daily Defense Protection Sunscreen Broad Spectrum SPF50 88.5; 19.1 mg/mL; mg/mL Details
Derm Institute Daily Defense Protection Sunscreen Broad Spectrum SPF50 88.5; 19.1 mg/mL; mg/mL
Derm Institute Daily Defense Protection Sunscreen Broad Spectrum SPF50 is a TOPICAL LOTION in the HUMAN OTC DRUG category. It is labeled and distributed by Beautcella Inc.. The primary component is TITANIUM DIOXIDE; ZINC OXIDE.
Product Information
| NDC | 81521-0001 |
|---|---|
| Product ID | 81521-001_bad942d8-04db-31d2-e053-2a95a90a9275 |
| 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 | Derm Institute Daily Defense Protection Sunscreen Broad Spectrum SPF50 |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | TITANIUM DIOXIDE, ZINC OXIDE |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | LOTION |
| Route | TOPICAL |
| Active Ingredient Strength | 88.5; 19.1 |
| Active Ingredient Units | mg/mL; mg/mL |
| Substance Name | TITANIUM DIOXIDE; ZINC OXIDE |
| Labeler Name | Beautcella Inc. |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH NOT FINAL |
| Application Number | part352 |
| Listing Certified Through | 2023-12-31 |
Package
Package Images
NDC 81521-0001-01 (81521000101)
| NDC Package Code | 81521-001-01 |
|---|---|
| Billing NDC | 81521000101 |
| Package | 1 BOTTLE, PLASTIC in 1 CARTON (81521-001-01) / 25 mL in 1 BOTTLE, PLASTIC |
| Marketing Start Date | 2021-05-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL bad942d8-04da-31d2-e053-2a95a90a9275 Details
Uses
Warnings
Directions
- Use in the a.m. after serum and before foundation or makeup
- apply liberally 15 minutes before sun exposure
- reapply at least every 2 hours
- use a water-resistant sunscreen if swimming or sweating
- children under 6 months of age: 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
Water (Aqua), Isononyl Isononanoate, Butylene Glycol, Caprylic/Capric Triglyceride, Cetyl Ethylhexanoate, Propanediol, Sodium Chloride, Diethylhexyl Carmonate, Stearic Acid, Alumina, Disteardimonium Hectorite, Polyhydroxystearic Acid, Iron Oxides (CI 77492), Phenoxyethanol, Bacopa Monnieri Extract, Lavandula Angustifolia (Lavender) Oil, Polyglyceryl-6 Polyricinoleate, Glycerin, Butyrospermum Parkii (Shea) Butter, Acetyl Tyrosine, Tocopheryl Acetate, Urea, Allantoin, o-Cymen-5-ol, Iron Oxides (CI 77491), Proline, Ethylhexylglycerin, Iron Oxides (CI 77499), Melaleuca Alternifolia (Tea Tree) Leaf Oil, Hydrolyzed Vegetable Protein, Adenosine Triphosphate, Hydroxyethylcellulose, Xanthophylls, PEG-12 Glyceryl Laurate, Rosmarinus Officininalis (Rosemary) Leaf Oil, PEG-35 Castor Oil, PVP, Lecithin, Alteromonas Ferment Extract, Magnesium Ascorbyl Phosphate, Silybum Marianum Extract, Potassium Sorbate, Caprylyl Glycol, Disodium EDTA, Tocopherol, Xanthan Gum, Ergothioneine, Chondrus Crispus Extract
INGREDIENTS AND APPEARANCE
| DERM INSTITUTE DAILY DEFENSE PROTECTION SUNSCREEN BROAD SPECTRUM SPF50
titanium dioxide, zinc oxide lotion |
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| Labeler - Beautcella Inc. (928453625) |