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Product NDC Code | 81159-394 | ||||
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Drug Name | Seaweed bath co. sheer mineral sensitive spf-50 |
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Type | Brand | ||||
Pharm Class | Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE] |
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Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | SOLUTION | ||||
Application Number | M020 | ||||
Labeler Name | The Seaweed Bath Co. | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Zinc Oxide 17.0% Purpose Sunscreen
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 15 minutes before sun exposure and as needed. • Children under 6 months: ask a doctor. • Reapply: • After 80 minutes of swimming or sweating • Immediately after towel drying • At least every two hours. • 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. Sun Protection Measures:
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Algae Extract, Allantoin, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, a-Bisabalol, Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Butter, Calendula Officinalis Extract, Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Caprylyl Glycol, l-Carnosine, Cetearyl Alcohol, Cetearyl Glucoside, Chamomilla Matricaria (Chamomile) Extract, Citric Acid, Citrullus Lanatus (Watermelon) Extract, Cocos Nucifera (Coconut) Oil, Fucus Vesiculosus (Seaweed) Extract, Glycerin, Glyceryl Laurate, Glyceryl Oleate, Glyceryl Stearate, Glyceryl Undecylenate, Methyl Abietate, Polyhydroxystearic Acid, Polysorbate-20, SD Alcohol, Silica, Sorbitan Stearate, Squalane, Tocopherol (Vitamin E), Ulva Lactuca (Sea Lettuce) Extract, Water, Xanthan Gum.
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 ), decreases the risk of skin cancer and early skin aging caused by the sun. Directions
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.SEAWEED BATH CO. Sheer Mineral Sensitive SPF-50 ZINC OXIDE ALLANTOIN ALOE VERA LEAF BUTYLOCTYL SALICYLATE SHEA BUTTER CALENDULA OFFICINALIS FLOWER GREEN TEA LEAF MEDIUM-CHAIN TRIGLYCERIDES CAPRYLYL GLYCOL CARNOSINE CETOSTEARYL ALCOHOL CETEARYL GLUCOSIDE CHAMOMILE WATERMELON COCONUT OIL FUCUS VESICULOSUS GLYCERIN GLYCERYL LAURATE GLYCERYL OLEATE GLYCERYL MONOSTEARATE METHYL ABIETATE POLYSORBATE 20 SILICON DIOXIDE SORBITAN MONOSTEARATE SQUALANE TOCOPHEROL ULVA LACTUCA WATER XANTHAN GUM ZINC OXIDE ZINC CATION
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.Package Labeling: Label2
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
Other Information Protect this product from excessive heat and direct sun.
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 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
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. Stop use and ask a doctor if rash occurs.
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 Contents under pressure. Do not puncture or incinerate container. Do not expose to heat or store at temperatures above 120°F (49°C). For external use only. Flammable: 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 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