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| Product NDC Code | 71047-364 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Alive prebiotic balancing moisturizer spf 15 |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | LOTION | ||||||
| Application Number | part352 | ||||||
| Labeler Name | Algenist, LLC | ||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients Zinc Oxide 13.65%
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions Apply to the entire face, neck, and décolleté, avoiding the eye area, in the morning. Use only as directed. Apply liberally to the entire face in the morning or 15 minutes prior to sun exposure Reapply at least every 2 hours Use a water resistant sunscreen if swimming or sweating Children under 6 months: Ask a doctor Apply to clean face with fingertips or brush and blend well. Layer for additional coverage as needed. 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: Limit time in the sun, especially from 10 a.m. – 2 p.m. Wear long-sleeve shirts, pants, hats, and sunglasses.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Water (Aqua, Eau), Caprylic/ Capric Triglyceride, Coco-Caprylate, Glycerin, Glyceryl Behenate, Coco-Glucoside, Simmondsia Chinensis (Jojoba) Seed Oil, Cetearyl Alcohol, Glyceryl Caprylate, Sodium Stearoyl Glutamate, Parachlorella Beijerinckii Exopolysaccharides, Chlorella Vulgaris Extract, Lactococcus Ferment Lysate, Alteromonas Ferment Extract, Caesalpinia Spinosa Fruit Pod Extract, Helianthus Annuus (Sunflower) Sprout Extract, Caprylyl Glycol, Microcrystalline Cellulose, Polyglyceryl-3 Polyricinoleate, Xanthan Gum, Butylene Glycol, Isostearic Acid, Caprylhydroxamic Acid, Algin, Calcium Alginate, Propanediol, Maltodextrin, Lactic Acid, Sodium Benzoate, Sodium Chloride.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.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.
Purpose
Information about the drug product’s indications for use.Purpose Sunscreen
Spl product data elements
Usually a list of ingredients in a drug product.Alive Prebiotic Balancing Moisturizer SPF 15 ZINC OXIDE WATER MEDIUM-CHAIN TRIGLYCERIDES COCO-CAPRYLATE GLYCERIN GLYCERYL MONOBEHENATE COCO GLUCOSIDE JOJOBA OIL CETOSTEARYL ALCOHOL GLYCERYL MONOCAPRYLATE SODIUM STEAROYL GLUTAMATE CAPRYLYL GLYCOL MICROCRYSTALLINE CELLULOSE POLYGLYCERYL-3 RICINOLEATE XANTHAN GUM BUTYLENE GLYCOL ISOSTEARIC ACID CAPRYLHYDROXAMIC ACID SODIUM ALGINATE CALCIUM ALGINATE PROPANEDIOL MALTODEXTRIN CHLORELLA VULGARIS CAESALPINIA SPINOSA FRUIT POD LACTIC ACID, UNSPECIFIED FORM SODIUM BENZOATE SODIUM CHLORIDE ZINC OXIDE ZINC OXIDE
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Principal Display Panel - 10 mL Box Label ALIVE Prebiotic Balancing Moisturizer SPF 15 Soin Prébiotique Équilibrant FPS 15 Broad Spectrum Sunscreen SPF 15 Écran Solaire Large Spectre FPS 15 ALGENIST Alguronic Acid + Prebiotic Principal Display Panel
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use on damaged or broken skin
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other Information Protect this product from excessive heat and direct sun.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions Call toll free 1-877-650-1837
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and consult a doctor if rash occurs
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product keep out of eyes. Rinse with water to remove
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings For external use only Do not use on damaged or broken skin When using this product keep out of eyes. Rinse with water to remove Stop use and consult a doctor if rash occurs Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API