NDC 51326-040 Derma-e Sensitive 3-in-1 Sunscreen Spf 30

Octocrylene, Octisalate, Avobenzone

NDC Product Code 51326-040

NDC Code: 51326-040

Proprietary Name: Derma-e Sensitive 3-in-1 Sunscreen Spf 30 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: Octocrylene, Octisalate, Avobenzone 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

  • 51326 - Topiderm Inc.
    • 51326-040 - Derma-e Sensitive 3-in-1 Sunscreen Spf 30

NDC 51326-040-00

Package Description: 118 mL in 1 TUBE

NDC Product Information

Derma-e Sensitive 3-in-1 Sunscreen Spf 30 with NDC 51326-040 is a a human over the counter drug product labeled by Topiderm Inc.. The generic name of Derma-e Sensitive 3-in-1 Sunscreen Spf 30 is octocrylene, octisalate, avobenzone. The product's dosage form is lotion and is administered via topical form.

Labeler Name: Topiderm Inc.

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.

Derma-e Sensitive 3-in-1 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.

  • OCTOCRYLENE 50 mg/mL
  • OCTISALATE 50 mg/mL
  • AVOBENZONE 30 mg/mL

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)
  • BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
  • GREEN TEA LEAF (UNII: W2ZU1RY8B0)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • CARTHAMUS TINCTORIUS SEED OLEOSOMES (UNII: 9S60Q72309)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • CETEARYL OLIVATE (UNII: 58B69Q84JO)
  • CUCUMBER (UNII: YY7C30VXJT)
  • CARROT (UNII: L56Z1JK48B)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • LICORICE (UNII: 61ZBX54883)
  • HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • SORBITAN OLIVATE (UNII: MDL271E3GR)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • CORN (UNII: 0N8672707O)
  • PROPANEDIOL (UNII: 5965N8W85T)

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: Topiderm Inc.
Labeler Code: 51326
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: 04-10-2019 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.

Derma-e Sensitive 3-in-1 Sunscreen Spf 30 Product Label Images

Derma-e Sensitive 3-in-1 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

Octocrylene 5%, Octisalate 5%,


Avobenzone 3%

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.

Do Not Use

On damaged or broken skin.

When Using This Product

Keep out of eyes. Rinse with water to remove.

Stop Use And Consult Physician

If irritation or rash develops.

Keep Out Of Reach Of Children.

If product is swallowed, get medical attention or contact poison control center immediately.

Directions

• Apply liberally 15-minutes before sun exposure.


• Reapply: At least every two-hours. Immediately after swimming, sweating or towel drying.


• 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 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-sleeve shirts, pants, hats, and sunglasses. Reapply at least every 2 hours.


• For children under 6-months, consult a physician.

Other Information

• Protect this product from excessive heat and direct sunlight.

Inactive Ingredients

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Betaglucan, Butyloctyl Salicylate, Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Carthamus Tinctorius (Safflower) Oleosomes, Cetearyl Alcohol, Cetearyl Olivate, Cucumis Sativus (Cucumber) Extract, Daucus Carota Sativa (Carrot) Extract, Dimethicone, Ethylhexylglycerin, Glycerin, Glycyrrhiza Glabra (Licorice) Extract, Helianthus Annuus (Sunflower) Oil, Hydrolyzed Oat Protein, Phenoxyethanol, Polysorbate-20, Silica, Sodium Hydroxide, Sorbitan Olivate, Stearic Acid, Styrene/Acrylates Copolymer, Xanthan Gum, Zemea (Corn) Propanediol.

* Please review the disclaimer below.

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