NDC 82240-223 Dermaka Broad Spectrum Spf-42 Sunscreen

Titanium Dioxide, Zinc Oxide

NDC Product Code 82240-223

NDC CODE: 82240-223

Proprietary Name: Dermaka Broad Spectrum Spf-42 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: Titanium Dioxide, Zinc Oxide 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

  • 82240 - Dermaka Skin Products
    • 82240-223 - Dermaka Broad Spectrum Spf-42 Sunscreen

NDC 82240-223-00

Package Description: 100 mL in 1 TUBE

NDC Product Information

Dermaka Broad Spectrum Spf-42 Sunscreen with NDC 82240-223 is a a human over the counter drug product labeled by Dermaka Skin Products. The generic name of Dermaka Broad Spectrum Spf-42 Sunscreen is titanium dioxide, zinc oxide. The product's dosage form is cream and is administered via topical form.

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

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.

Dermaka Broad Spectrum Spf-42 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.


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.

  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • WATER (UNII: 059QF0KO0R)
  • BROMELAINS (UNII: U182GP2CF3)
  • BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
  • GREEN TEA LEAF (UNII: W2ZU1RY8B0)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • CAPRYLYL/CAPRYL OLIGOGLUCOSIDE (UNII: E00JL9G9K0)
  • CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • CHAMOMILE (UNII: FGL3685T2X)
  • WATERMELON (UNII: 231473QB6R)
  • COCONUT OIL (UNII: Q9L0O73W7L)
  • DODECANE (UNII: 11A386X1QH)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • GLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544)
  • LICORICE (UNII: 61ZBX54883)
  • SUNFLOWER OIL (UNII: 3W1JG795YI)
  • HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • FERROSOFERRIC OXIDE (UNII: XM0M87F357)
  • FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • CORN (UNII: 0N8672707O)

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: Dermaka Skin Products
Labeler Code: 82240
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: 09-21-2021 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.

Dermaka Broad Spectrum Spf-42 Sunscreen Product Label Images

Dermaka Broad Spectrum Spf-42 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

Titanium dioxide 6.00%


Zinc Oxide 7.70%

Purpose

Sunscreen

Uses:

  • Helps prevent sunburn.higher SPF gives more sunburn protectionIf 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 not intended for ingestion.

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 or irritation develops and lasts.

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.Children under 6 months of age: ask a doctor.Reapply:afte 80 minutes of swimming or sweatingimmediately after towel dryingat least every 2 hoursSun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with broad spectrum SPF 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 the product in this container from excessive heat and direct sun.

Inactive Ingredients:

Aloe Barbadensis Leaf (Aloe Vera gel) Juice, Aqua (Deionized Water), Bromelain, Butyloctyl Salicylate, Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Caprylyl/Capryl Glucoside, Capryloyl Glycerin/Sebacic Acid Copolymer, Cetearyl Alcohol, Chamomilla Recututa (Chamomile) Extract, Citrullus Lanatus (Watermelon) Extarct, Cocos Nucifera (Coconut) Oil, Dodecane, Glycerin, Glyceryl Caprylate, Glyceryl Stearate, Glyceryl Undecylenate, Glycyrrhiza Glabra (Licorice) Extarct, Hawthorn Extract, Helianthus Annuus (Sunflower) Oil, Hydroxyethylcellulose, Iron Oxides (Black, Red, White, Yellow), Polyhydroxystearic Acid, Sambucus Nigra (Elderberry) Extarct, Sodium Polyacrylate, Stearic Acid, Tocopheryl Acetate (Vitamin E), Zemea (Corn) Propanediol.

Questions?

(772) 266-3376

* Please review the disclaimer below.