NDC 52993-127 Zinka Spf 30 Clear Sunscreen

Avobenzone 3%, Homosalate 15%, Octisalate 5%, Octocrylene 8%

NDC Product Code 52993-127

NDC CODE: 52993-127

Proprietary Name: Zinka Spf 30 Clear Sunscreen 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.

Non-Proprietary Name: Avobenzone 3%, Homosalate 15%, Octisalate 5%, Octocrylene 8% 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.

NDC Code Structure

  • 52993 - Zinka, Inc

NDC 52993-127-06

Package Description: 170 g in 1 CAN

NDC Product Information

Zinka Spf 30 Clear Sunscreen with NDC 52993-127 is a a human over the counter drug product labeled by Zinka, Inc. The generic name of Zinka Spf 30 Clear Sunscreen is avobenzone 3%, homosalate 15%, octisalate 5%, octocrylene 8%. The product's dosage form is spray and is administered via topical form.

Labeler Name: Zinka, Inc

Dosage Form: Spray - A liquid minutely divided as by a jet of air or steam.

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.

Zinka Spf 30 Clear Sunscreen 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.

  • HOMOSALATE 15 g/100g
  • OCTISALATE 5 g/100g
  • AVOBENZONE 3 g/100g
  • OCTOCRYLENE 8 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.

  • ALCOHOL (UNII: 3K9958V90M)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)
  • STEAROXYTRIMETHYLSILANE (UNII: 9862TW94B2)
  • TOCOPHEROL (UNII: R0ZB2556P8)

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: Zinka, Inc
Labeler Code: 52993
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: 04-19-2021 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 - NO 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".

* Please review the disclaimer below.

Zinka Spf 30 Clear Sunscreen Product Label Images

Zinka Spf 30 Clear Sunscreen 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 Ingredients

Avobenzone 3%, Homosalate 15%, Octisalate 5%, Octocrylene 8%

Purpose

Sunscreen

Uses

  • Helps prevent sunburn

Warnings

For external use only.
Flammable: do not use while smoking or near heat or flame. Do not use on damaged or broken skin.
When using this product keep out of eyes. Rinse eyes with water to remove. Contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120 degrees F.
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.

Directions

  • Apply liberally 15 minutes before sun exposure. Reapply:after 80 minutes of swimming or sweatingimmediately after towel dryingat least every 2 hoursSun protection measures: spending time n the sun increases your risk of skin cancer and early skin aging. To decrease risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other sun protection measure including:
  • Limit time in the sun, especially from 10 am to 2 pmwear long-sleeved shirts, pants, hats, and sunglasses.Children under 6 months: ask a doctor.Hold container 4 to 6 inches from the skin to apply. Do not spray directly into face. Spray on hands then apply to face. Do no apply in windy conditions. Use in a well-ventilated area.

Inactive Ingredients

Acrylates/Octylacrylamide Copolymer, Alcohol Denat., Caprylic/Capric Triglyceride, Diethylhexyl Syringylidenemalonate, Fragrance, Glycerin, Stearoxytrimethysilane, Tocopherol.

* Please review the disclaimer below.