NDC 71909-6567 But First Water

Ethylhexyl Methoxycinnamate, Zinc Oxide, Titanium Dioxide, 4-methylbenzylidene Camphor

NDC Product Code 71909-6567

NDC Code: 71909-6567

Proprietary Name: But First Water 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: Ethylhexyl Methoxycinnamate, Zinc Oxide, Titanium Dioxide, 4-methylbenzylidene Camphor 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

  • 71909 - Cnt Dream Co.,ltd
    • 71909-6567 - But First Water

NDC 71909-6567-0

Package Description: 55 g in 1 BOTTLE, PUMP

NDC Product Information

But First Water with NDC 71909-6567 is a a human over the counter drug product labeled by Cnt Dream Co.,ltd. The generic name of But First Water is ethylhexyl methoxycinnamate, zinc oxide, titanium dioxide, 4-methylbenzylidene camphor. The product's dosage form is cream and is administered via topical form.

Labeler Name: Cnt Dream Co.,ltd

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.

But First Water 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.

  • TITANIUM DIOXIDE 1.925 g/55g
  • OCTINOXATE 2.75 g/55g
  • ZINC OXIDE 2.2 g/55g
  • ENZACAMENE .715 g/55g

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.

  • METHYLPROPANEDIOL (UNII: N8F53B3R4R)

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: Cnt Dream Co.,ltd
Labeler Code: 71909
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: 04-02-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

End Marketing Date: 04-01-2020 What is the End Marketing Date?
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.

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.

But First Water 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

Indications & Usage Section

*helps prevent sunburn

*if used as directed with other sun protection measures (see Directions),

decreases the risk fo skin cancer and early skin aging caused by the sun
Directions:

Apply a proper amount evenly for the last step of skin care.

For sunscreen use:

*apply liberally 15 minutes before sun exposure

*reapply at least every 2 hours

*use a water resistant sunscreen if swimming or sweating

*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 value of 15 or higher and other sun protection measures including:

*limit time in the sun, especially from 10a.m-2p.m

*wear long-sleeved shirts, pants, hats, and sunglasses

*children under 6 months of age: Ask a doctor

Otc -Active Ingredient Section

Ethylhexyl Methoxycinnamate 5% sunscreen
Zinc Oxide 4% sunscreenTitanium Dioxide 3.5% sunscreen4-Methylbenzylidene Camphor 1.3% sunscreen

Otc- Ask Doctor Section

Stop use and ask a doctor if rash or irration develops and lasts

Otc - Keep Out Of Reach Of Children Section

Keep out of reach of children

Otc Do Not Use Section

Do not use on damaged or broken skin

Warning Section

*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 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

Otc - Purpose Section

Water cream

Inactive Ingredient Section

Camellia Sinensis Leaf Extract, Methylpropanediol, Cyclopentasiloxane, Dimethicone/Vinyl Dimethicone Crosspolymer, Cyclopentasiloxane, PPG-14 Butyl Ether, Alcohol, Niacinamide, Hydrogenated Ethylhexyl Olivate, Hydrogenated Olive Oil Unsaponifiables, Sea Water, Polyglyceryl-3 Methylglucose Distearate, 1,2-Hexanediol, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Caprylyl Glycol, Ammonium Acryloyldimethyltaurate/VP Copolymer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Ethylhexylglycerin, Tromethamine, Adenosine, Citrus Limon (Lemon) Fruit Oil, Aniba Rosaeodora (Rosewood) Wood Oil, Disodium EDTA, 3-O-Ethyl Ascorbic Acid, Glycerin, Sodium Hyaluronate, Tocopheryl Acetate, Undaria Pinnatifida Extract, Laminaria Japonica Extract, Hizikia Fusiforme Extract, Water, Butylene Glycol,

Calendula Officinalis Flower Extract, Forsythia Suspensa Fruit Extract, Dictyopteris Polypodioides Extract

* Please review the disclaimer below.

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