NDC 60396-202 Zinc Five-o Spf-50

Zinc Oxide

NDC Product Code 60396-202

NDC 60396-202-11

Package Description: 100 g in 1 TUBE

NDC Product Information

Zinc Five-o Spf-50 with NDC 60396-202 is a a human over the counter drug product labeled by Antaria Pty Ltd. The generic name of Zinc Five-o Spf-50 is zinc oxide. The product's dosage form is lotion and is administered via topical form.

Labeler Name: Antaria Pty Ltd

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.

Zinc Five-o Spf-50 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 25 g/100g

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.

  • COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • COCONUT ALKANES (UNII: 1E5KJY107T)
  • JOJOBA OIL (UNII: 724GKU717M)
  • POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)
  • YELLOW WAX (UNII: 2ZA36H0S2V)
  • ISOSTEARIC ACID (UNII: X33R8U0062)
  • POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
  • MALTODEXTRIN (UNII: 7CVR7L4A2D)
  • PHENYLPROPANOL (UNII: 0F897O3O4M)
  • PROPANEDIOL (UNII: 5965N8W85T)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • CETYL PHOSPHATE (UNII: VT07D6X67O)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)

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: Antaria Pty Ltd
Labeler Code: 60396
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: 05-26-2019 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: 12-31-2020 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.

Zinc Five-o Spf-50 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

Uses

  • Helps prevent sunburnIf used as directed with other sun protection measures (see Directions), decreased the risk of skin cancer and early skin aging caused by the sun

Warnings

For external use onlyDo not use on damaged or broken skin.When using this product keep out of eyes. Rinse with water to remove.Stop use and ask doctor if rash occurs.

Directions:

Apply liberally and evenly 15 minutes before sun exposure. Reapply: • After 40 minutes of swimming or sweating • Immediately after towel drying • At least every 2 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•Children under 6 months of age: ask a doctor.

Other Information

Store at temperatures below 90°F.

Inactive Ingredients

Coco-caprylate/caprate, glycerine, coconut alkane, simmondsia chinensis (jojoba) seed oil, polyglyceryl-3-polyricinoleate, cera alba (beeswax), isostearic acid, polyhydroxy stearic acid, maltodextrin, phenylpropanol, propanediol, caprylyl glycol, tocopherol, ethylhexylglycerin, cetyl phosphate, sodium chloride, disodium EDTA

* Please review the disclaimer below.

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