NDC 69013-026 Orday Mild Suncream

Zinc Oxide, Titanium Dioxide

NDC Product Code 69013-026

NDC Code: 69013-026

Proprietary Name: Orday Mild Suncream 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: Zinc Oxide, Titanium Dioxide 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

  • 69013 - Elishacoy Co., Inc
    • 69013-026 - Orday Mild Suncream

NDC 69013-026-02

Package Description: 1 CONTAINER in 1 CARTON > 50 mL in 1 CONTAINER (69013-026-01)

NDC Product Information

Orday Mild Suncream with NDC 69013-026 is a a human over the counter drug product labeled by Elishacoy Co., Inc. The generic name of Orday Mild Suncream is zinc oxide, titanium dioxide. The product's dosage form is cream and is administered via topical form.

Labeler Name: Elishacoy Co., Inc

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.

Orday Mild Suncream 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 116.4 mg/mL
  • TITANIUM DIOXIDE 31.2 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.

  • WATER (UNII: 059QF0KO0R)
  • CYCLOMETHICONE (UNII: NMQ347994Z)
  • POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: RLA2U05Z4Q)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • PROPANEDIOL (UNII: 5965N8W85T)
  • DIBUTYL ADIPATE (UNII: F4K100DXP3)
  • CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
  • 1,2-HEXANEDIOL (UNII: TR046Y3K1G)
  • DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
  • CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
  • MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
  • HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
  • BETAINE (UNII: 3SCV180C9W)
  • TREHALOSE (UNII: B8WCK70T7I)
  • ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
  • SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
  • STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
  • TRANEXAMIC ACID (UNII: 6T84R30KC1)
  • INOSITOL (UNII: 4L6452S749)
  • ORANGE OIL (UNII: AKN3KSD11B)
  • PENTYLENE GLYCOL (UNII: 50C1307PZG)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • OCTYLDODECANOL (UNII: 461N1O614Y)
  • BERGAMOT OIL (UNII: 39W1PKE3JI)
  • LAVENDER OIL (UNII: ZBP1YXW0H8)
  • ROSA X DAMASCENA FLOWER OIL (UNII: 18920M3T13)
  • LITSEA OIL (UNII: 2XIW34BN6O)
  • ECHIUM PLANTAGINEUM SEED OIL (UNII: PIB7XBU8XW)
  • GERANIUM OIL, ALGERIAN TYPE (UNII: 5Q1I94P4WG)
  • BASIL OIL (UNII: Z129UMU8LE)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • CARDIOSPERMUM HALICACABUM FLOWERING TOP (UNII: MZP2508BRR)
  • METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: 657L0NC5MT)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • 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: Elishacoy Co., Inc
Labeler Code: 69013
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: 04-18-2019 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.

Orday Mild Suncream Product Label Images

Orday Mild Suncream 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

Zinc Oxide 11.64%


Titanium Dioxide 3.12%

Otc - Purpose

Sunscreen

Indications & Usage

Helps prevent sunburn

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, Cyclomethicone, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Glycerin, Calamine, Propanediol, Dibutyl Adipate, Caprylyl Methicone, 1,2-Hexanediol, Disteardimonium Hectorite, Cetyl Ethylhexanoate, Magnesium Sulfate, Hydrogen Dimethicone, Betaine, Trehalose, Aluminum Hydroxide, C30-45 Alkyl Cetearyl Dimethicone Crosspolymer, Sorbitan Sesquioleate, Styrene/Acrylates Copolymer, Stearic Acid, Dipotassium Glycyrrhizate, Tranexamic Acid, Inositol, Citrus Aurantium Dulcis (Orange) Peel Oil, Pentylene Glycol, Ethylhexylglycerin, Octyldodecanol, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Lavandula Angustifolia (Lavender) Oil, Rosa Damascena Flower Water, Litsea Cubeba Fruit Oil, Echium Plantagineum Seed Oil, Pelargonium Graveolens Oil, Ocimum Basilicum (Basil) Oil, Butylene Glycol, Cardiospermum Halicacabum Flower/Leaf/Vine Extract, Helianthus Annuus (Sunflower) Seed Oil Unsaponifiables, Methyl Methacrylate Crosspolymer, Glyceryl Stearate, Xanthan Gum, Tocopherol

* Please review the disclaimer below.

Previous Code
69013-025
Next Code
69015-100