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| Product NDC Code | 81159-387 | ||||
|---|---|---|---|---|---|
| Drug Name | Dewy skin face |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LOTION | ||||
| Application Number | part352 | ||||
| Labeler Name | The Seaweed Bath Co. | ||||
| 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 Ingredient Zinc Oxide 20.8%
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 liberally and evenly as the last step in your skin care routine and 15 minutes before sun exposure. Wear alone or under makeup Reapply at least every two 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.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Aqua/Water/Eau with Fucus Vesiculosus (Bladderwrack Seaweed) and Chlorella Vulgaris (Algae) Extracts, Caprylic/Capric Triglyceride, Butyloctyl Salicylate, Polyglyceryl-6 Distearate, Glycerin, Betaine, Glyceryl Stearate, Sorbitan Sesquioleate, Caprylhydroxamic Acid, Glyceryl Caprylate, Diheptyl Succinate, Capryloyl Glycerin/Sebacic Acid Copolymer, Natural Fragrance, Polyhydroxystearic Acid, Squalane, Niacinamide, Sodium Hyaluronate, Red Algae (Gigartina Skottsbergii) Extract, Sodium PCA, Tocopheryl Acetate (Vitamin E), Xanthan Gum, Tetrahexyldecyl Ascorbate (Vitamin C), Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Sambucus Nigra (Black Elderberry) Fruit Extract, Citric Acid, Juniperus Communis Fruit Extract, Allantoin, Frangula Alnus Bark (Buckthorn) Extract, Bisabolol, Ocimum Basilicum (Basil) Flower/Leaf Extract, Sodium Stearoyl Glutamate, Betula Alba (Birch) Leaf Extract, Tocopheryl (Vitamin E).
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.Dewy Skin Face Zinc Oxide Zinc Oxide Zinc Oxide WATER FUCUS VESICULOSUS CHLORELLA VULGARIS MEDIUM-CHAIN TRIGLYCERIDES BUTYLOCTYL SALICYLATE POLYGLYCERYL-6 DISTEARATE GLYCERIN BETAINE GLYCERYL MONOSTEARATE SORBITAN SESQUIOLEATE CAPRYLHYDROXAMIC ACID GLYCERYL MONOCAPRYLATE DIHEPTYL SUCCINATE CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) POLYHYDROXYSTEARIC ACID STEARATE SQUALANE NIACINAMIDE HYALURONATE SODIUM SODIUM PYRROLIDONE CARBOXYLATE .ALPHA.-TOCOPHEROL ACETATE XANTHAN GUM TETRAHEXYLDECYL ASCORBATE ALOE VERA LEAF SAMBUCUS NIGRA FLOWERING TOP CITRIC ACID MONOHYDRATE JUNIPER BERRY ALLANTOIN FRANGULA ALNUS BARK LEVOMENOL BASIL SODIUM STEAROYL GLUTAMATE BETULA PUBESCENS LEAF TOCOPHEROL
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 - 59 mL Bottle Carton SEAWEED ® BATH CO. mineral SPF hydrate & protect DEWY SKIN FACE LOTION with squalane & hyaluronic acid SPF 30 SUNSCREEN SEA MAGIC Broad Spectrum SPF 30 2.0 fl oz (59 mL) PRINCIPAL DISPLAY PANEL - 59 mL Tube Carton
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
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 swallowed, get medical help or contact a Poison Control Center right away.
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 1-877-317-3106
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 ask 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.
Storage and handling
Information about safe storage and handling of the drug product.Other Information Protect this product from excessive heat and direct sun.
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 ask a doctor if rash occurs. Keep out of reach of children . If 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