NDC 81486-002 Wotnot Naturals Natural Sunscreen Spf 30

Zinc Oxide

NDC Product Code 81486-002

NDC 81486-002-01

Package Description: 1 TUBE in 1 BOX > 150 g in 1 TUBE

NDC Product Information

Wotnot Naturals Natural Sunscreen Spf 30 with NDC 81486-002 is a a human over the counter drug product labeled by Ecodirect Pty Ltd (trading As Wotnot Naturals). The generic name of Wotnot Naturals Natural Sunscreen Spf 30 is zinc oxide. The product's dosage form is lotion and is administered via topical form.

Labeler Name: Ecodirect Pty Ltd (trading As Wotnot Naturals)

Dosage Form: Lotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2

Product Type: Human Otc Drug 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.

Wotnot Naturals Natural Sunscreen Spf 30 Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • ZINC OXIDE 250 mg/g

Inactive Ingredient(s)

About the Inactive Ingredient(s)
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.

  • TOCOPHEROL (UNII: R0ZB2556P8)
  • JOJOBA OIL (UNII: 724GKU717M)
  • CARNAUBA WAX (UNII: R12CBM0EIZ)
  • CANDELILLA WAX (UNII: WL0328HX19)
  • GRAPE SEED OIL (UNII: 930MLC8XGG)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • WATER (UNII: 059QF0KO0R)
  • SESAME OIL (UNII: QX10HYY4QV)
  • YELLOW WAX (UNII: 2ZA36H0S2V)
  • SHEA BUTTER (UNII: K49155WL9Y)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • SAFFLOWER OIL (UNII: 65UEH262IS)

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.

Labeler Name: Ecodirect Pty Ltd (trading As Wotnot Naturals)
Labeler Code: 81486
FDA Application Number: part352 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.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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.

Start Marketing Date: 02-01-2021 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2022 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.

Exclude Flag: N 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Wotnot Naturals Natural Sunscreen Spf 30 Product Label Images

Wotnot Naturals Natural Sunscreen Spf 30 Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredient

Zinc Oxide 25%

Purpose

Sunscreen

Use

  • 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 sun.

Warnings

For external use only.

Do Not Use

On damaged or broken skin.

Stop Use And Ask A Doctor

If rash or irritation occurs.

When Using This Product

Keep out of eyes. Rinse with water to remove.

Keep Out Of Reach Of Children.

If swallowed get medical help, or contact a Poison Control Centre right away.

Directions

  • Shake well before use and apply liberally 15 minutes before sun exposure.Reapply regularly, at least every 2 hours, after swimming, towelling dry or perspiring.Use a water resistant sunscreen if swimming or perspiring.Children under 6 months: ask a doctor.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 Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
  • Limit time in the sun, especially 10am-2pm.Wear long-sleeved shirts, pants, hats and sunglasses.

Inactive Ingredients

Vitis vinifera (grape) seed oil, simmondsia chinensis (jojoba) seed oil, carthamus tinctorius (safflower) oil, sesamum indicum (sesame) seed oil, cera alba (beeswax), silica, butyrospermum parkii (shea butter), purified water, fragrance (natural), aloe barbadensis (aloe vera) extract, tocopherol (vitamin e), euphorbia cerifera (candelilla) wax, copernicia prunifera (carnauba) wax.

Other Information

  • Protect product from excessive heat and direct sun.Report serious adverse reactions to: Report Reaction, PO Box 22, Plainsboro, New Jersey 08536

Company Information

Wotnot Naturals Pty Ltd, 5/19 Rodborough Road, Frenchs Forest, NSW 2086, Australia

* Please review the disclaimer below.