NDC 69924-006 Neogen Dermalogy Day-light Protection Sun Screen Spf50

Titanium Dioxide, Zinc Oxide, Octinoxate

NDC Product Code 69924-006

NDC CODE: 69924-006

Proprietary Name: Neogen Dermalogy Day-light Protection Sun Screen Spf50 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, Octinoxate 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

  • 69924 - Outin Futures Corp.
    • 69924-006 - Neogen Dermalogy Day-light Protection Sun Screen Spf50

NDC 69924-006-02

Package Description: 1 CONTAINER in 1 CARTON > 46.78 g in 1 CONTAINER (69924-006-01)

NDC Product Information

Neogen Dermalogy Day-light Protection Sun Screen Spf50 with NDC 69924-006 is a a human over the counter drug product labeled by Outin Futures Corp.. The generic name of Neogen Dermalogy Day-light Protection Sun Screen Spf50 is titanium dioxide, zinc oxide, octinoxate. The product's dosage form is cream and is administered via topical form.

Labeler Name: Outin Futures Corp.

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.

Neogen Dermalogy Day-light Protection Sun Screen Spf50 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.

  • OCTINOXATE 3.51 g/46.78g
  • TITANIUM DIOXIDE .42 g/46.78g
  • ZINC OXIDE 1.31 g/46.78g

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.

  • WATER (UNII: 059QF0KO0R)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • BEMOTRIZINOL (UNII: PWZ1720CBH)
  • ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
  • HEXANEDIOL (UNII: ZIA319275I)
  • AMILOXATE (UNII: 376KTP06K8)
  • DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • HYALURONATE SODIUM (UNII: YSE9PPT4TH)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • PEG-100 STEARATE (UNII: YD01N1999R)
  • CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
  • PURSLANE (UNII: M6S840WXG5)
  • LAVENDER OIL (UNII: ZBP1YXW0H8)
  • PHYLLANTHUS EMBLICA FRUIT (UNII: YLX4CW2576)
  • RASPBERRY (UNII: 4N14V5R27W)
  • LOWBUSH BLUEBERRY (UNII: G90PX41VP0)
  • ACAI (UNII: 46AM2VJ0AW)
  • AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
  • CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
  • LIPPIA CITRIODORA LEAF (UNII: 9B1F4HKA9O)
  • ROSA DAMASCENA FLOWER (UNII: JWB78P295A)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • ANGELICA ARCHANGELICA ROOT (UNII: DTN01M69SN)
  • HIBISCUS SABDARIFFA FLOWER (UNII: 45TGG6IU6M)
  • WORMWOOD (UNII: F84709P2XV)
  • ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
  • POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
  • ALUMINUM OXIDE (UNII: LMI26O6933)
  • GENTIANA LUTEA ROOT (UNII: S72O3284MS)
  • ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK)
  • LITSEA OIL (UNII: 2XIW34BN6O)
  • CITRUS LIMON FRUIT OIL (UNII: 0HNC1J1YED)
  • EUCALYPTUS OIL (UNII: 2R04ONI662)
  • CEDRUS ATLANTICA BARK OIL (UNII: ZX5QRE4U60)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
  • ORANGE OIL (UNII: AKN3KSD11B)
  • ALUMINUM STEARATE (UNII: U6XF9NP8HM)

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: Outin Futures Corp.
Labeler Code: 69924
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: 12-14-2017 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.

Neogen Dermalogy Day-light Protection Sun Screen Spf50 Product Label Images

Neogen Dermalogy Day-light Protection Sun Screen Spf50 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

Otc - Active Ingredient

Titanium Dioxide 0.90%


Ethylhexyl Methoxycinnamate 7.50%


Zinc Oxide 2.80%

Otc - Purpose

Helps to prevent sunburn

Indications & Usage

Apply liberally 15 minutes before sun exposure. Reapply at least every two 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 of 15 of higher and other sun protection measures including: 1) Limited time in the sun, especially from 10 am to 2 pm. 2) Wear long-sleeve shirts, pants, hats, and sunglasses.Ask a doctor to use for children under 6 months.

Dosage & Administration

Apply liberally 15 minutes before sun exposure. Reapply at least every two hours.

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 using and ask a doctor if rash occurs.

Otc - Keep Out Of Reach Of Children

Keep out of reach of the children. If product is swallowed, get medical help or contact a poison control center right away.

Inactive Ingredient

Water, Glycerin, Butylene Glycol, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, C12-15 Alkyl Benzoate, Hexanediol, Isoamyl P-Methoxycinnamate, Dicaprylyl Carbonate, Cetearyl Alcohol, Xanthan Gum, Polysorbate 20, Sodium Hyaluronate, Glyceryl Stearate, Peg-100 Stearate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Portulaca Oleracea Extract, Lavandula Angustifolia (Lavender) Oil, Phyllanthus Emblica Fruit Extract, Rubus Idaeus(Raspberry) Fruit Extract, Vaccinium Angustifolium (Blueberry) Fruit Extract, Euterpe Oleracea Fruit Extract, Ammonium Acryloyldimethyltaurate/Vp Copolymer, Carbomer, Lippia Citriodora Leaf Extract, Rosa Damascena Flower Extract, Tocopheryl Acetate, Angelica Archangelica Root Extract, Beta-Glucan, Hibiscus Sabdariffa Flower Extract, Artemisia Absinthium Extract, Arnica Montana Flower Extract, Polyhydroxystearic Acid, Alumina, Gentiana Lutea Root Extract, Achillea Millefolium Extract, Litsea Cubeba Fruit Oil, Citrus Limon (Lomon) Fruit Oil, Eucalyptus Globulus Leaf Oil, Cedrus Atlantica Wood Oil, Disodium Edta, Potassium Hydroxide, Citrus Aurantium Dulcis(Orange) Oil, Aluminum Stearate

* Please review the disclaimer below.