NDC 81159-393 Seaweed Bath Co. Clear Moisture Mineral Spf-30
Zinc Oxide Solution Topical

Product Information

What is NDC 81159-393?

The NDC code 81159-393 is assigned by the FDA to the product Seaweed Bath Co. Clear Moisture Mineral Spf-30 which is a human over the counter drug product labeled by The Seaweed Bath Co.. The generic name of Seaweed Bath Co. Clear Moisture Mineral Spf-30 is zinc oxide. The product's dosage form is solution and is administered via topical form. The product is distributed in a single package with assigned NDC code 81159-393-00 177 ml in 1 can . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.

NDC Product Code81159-393
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.		Seaweed Bath Co. Clear Moisture Mineral Spf-30
Non-Proprietary Name What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.		Zinc Oxide
Product Type What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.		Human Otc Drug
Dosage FormSolution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route(s) What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.		The Seaweed Bath Co.
Labeler Code81159
FDA Application Number What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.		part352
Marketing Category What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.		OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.		03-06-2023
Listing Expiration Date What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.		12-31-2024
Exclude Flag What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I". 		N
NDC Code Structure

What are the uses for Seaweed Bath Co. Clear Moisture Mineral Spf-30?


Product Packages

NDC Code 81159-393-00

Package Description: 177 mL in 1 CAN

Product Details

What are Seaweed Bath Co. Clear Moisture Mineral Spf-30 Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
  • ZINC OXIDE 120 mg/mL - A mild astringent and topical protectant with some antiseptic action. It is also used in bandages, pastes, ointments, dental cements, and as a sunblock.

Seaweed Bath Co. Clear Moisture Mineral Spf-30 Active Ingredients UNII Codes

Seaweed Bath Co. Clear Moisture Mineral Spf-30 Inactive Ingredients UNII Codes

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

Pharmacologic Class(es)

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

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Seaweed Bath Co. Clear Moisture Mineral Spf-30 Product Label

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Label Table of Contents



Drug Facts




Active Ingredient



Zinc Oxide 12.0%


Purpose



Sunscreen


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.


Warnings



For external use only. Flammable: Contents under pressure. Do not puncture or incinerate container. Do not expose to heat or store at temperatures above 120°F (49°C).


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.


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.

• 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.


Other Information



Protect this product from excessive heat and direct sun.


Inactive Ingredients



Algae Extract, Allantoin, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Argania Spinosa (Argan) Oil, Calendula Officinalis Extract, Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Caprylyl Glycol, Cereus Grandiflorus (Cactus) Extract, Chamomilla Matricaria (Chamomile) Extract, Citric Acid, Citrullus Lanatus (Watermelon) Extract, Cocos Nucifera (Coconut) Oil, Decyl Glucoside, Dodecane, Fucus Vesiculosus  (Seaweed) Extract, Glycerin, Glyceryl Laurate, Glyceryl Stearate, Glyceryl Stearate Citrate, Glyceryl Undecylenate, Helianthus Annuus (Sunflower) Oil, Hyaluronic Acid, Natural Fragrance, Persea Gratissima (Avocado) Oil, Polyhydroxystearic Acid, Saccharide Isomerate, Simmondsia Chinensis (Jojoba) Oil, Sorbitan Stearate, Tocopherol (Vitamin E), Tridecyl Salicylate, Water, Xanthan Gum.


Questions?



Call toll free 1-877-317-3106


Package Labeling:



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