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NDC 71100-0001-90 Stout Daily SPF for Men 8.82 g/90mL Details
Stout Daily SPF for Men 8.82 g/90mL
Stout Daily SPF for Men is a TOPICAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Stout Face Care Inc.. The primary component is ZINC OXIDE.
Product Information
| NDC | 71100-0001 |
|---|---|
| Product ID | 71100-001_b4e2c44e-3027-45d1-969c-bd3e6596fcd5 |
| 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 | Stout Daily SPF for Men |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Sunscreen |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | LIQUID |
| Route | TOPICAL |
| Active Ingredient Strength | 8.82 |
| Active Ingredient Units | g/90mL |
| Substance Name | ZINC OXIDE |
| Labeler Name | Stout Face Care Inc. |
| 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 71100-0001-90 (71100000190)
| NDC Package Code | 71100-001-90 |
|---|---|
| Billing NDC | 71100000190 |
| Package | 90 mL in 1 TUBE (71100-001-90) |
| Marketing Start Date | 2017-03-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL cebbb3b5-4a68-4fbb-a12e-4e46a04c82dd Details
SPL UNCLASSIFIED SECTION
- apply liberally and evenly 15 minutes before sun exposure
- apply to all skin exposed to sun
- 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-sleeve shirts, pants, hats, and sunglasses
- children under 6 months of age: Ask a doctor
SPL UNCLASSIFIED SECTION
Purified water (eau), Caprylic/Capric Triglyceride, Polyhydroxystearic Acid, Polyglyceryl-3 Polyricinoleate, Isostearic Acid, Lecithin, Emulsifying Wax (Cetyl Alcohol, Stearyl Alcohol, Polysorbate 60), Glycerin, Vitis Vinifera (Grape) Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Sesamum Indicum (Sesame) Seed Oil, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Phenoxyethanol, Caprylyl Glycol, Borago Officinalis Seed Oil, Cannabis Sativa Seed Oil, Oenothera Biennis (Evening Primrose) Oil, Hippophae Rhamnoides Seed Oil, Butyrospermum Parkii (Shea) Butter, Menthol, Xanthan Gum, Citrus Aurantium Dulcis (Orange) Peel Oil, Pogostemon Cablin Oil, Evernia Prunastri (Oakmoss) Extract, Citus Aurantium Bergamie (Bergamot Fruit) Oil, Cedrus Deodara Wood Oil, Tocopherol, Euphorbia Cerifera (Candelilla) Wax, Aloe Barbadensis Leaf Powder
SPL UNCLASSIFIED SECTION
INGREDIENTS AND APPEARANCE
| STOUT DAILY SPF FOR MEN
sunscreen liquid |
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| Labeler - Stout Face Care Inc. (203411616) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Apollo Health and Beauty Care | 201901209 | manufacture(71100-001) | |