NDC 72894-003 Nuori Mineral Defence Sunscreen Spf 30

Zinc Oxide

NDC Product Code 72894-003

NDC Code: 72894-003

Proprietary Name: Nuori Mineral Defence 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: 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

  • 72894 - Nuori Aps
    • 72894-003 - Nuori Mineral Defence Sunscreen Spf 30

NDC 72894-003-01

Package Description: 1 TUBE in 1 CARTON > 50 mL in 1 TUBE

NDC Product Information

Nuori Mineral Defence Sunscreen Spf 30 with NDC 72894-003 is a a human over the counter drug product labeled by Nuori Aps. The generic name of Nuori Mineral Defence Sunscreen Spf 30 is zinc oxide. The product's dosage form is cream and is administered via topical form.

Labeler Name: Nuori Aps

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.

Nuori Mineral Defence 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.

  • ZINC OXIDE 230 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.

  • BETA CAROTENE (UNII: 01YAE03M7J)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • ISOSTEARIC ACID (UNII: X33R8U0062)
  • ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • KARUM SEED OIL (UNII: 62160PU6FJ)
  • SORBITAN OLIVATE (UNII: MDL271E3GR)
  • DOCOSANOL (UNII: 9G1OE216XY)
  • ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
  • SUNFLOWER OIL (UNII: 3W1JG795YI)
  • CARROT SEED OIL (UNII: 595AO13F11)
  • MARITIME PINE (UNII: 50JZ5Z98QY)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • WATER (UNII: 059QF0KO0R)
  • CAPRYLYL CAPRYLATE/CAPRATE (UNII: 22MCG4RSMR)
  • ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
  • CARROT (UNII: L56Z1JK48B)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • CETEARYL OLIVATE (UNII: 58B69Q84JO)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • COCO GLUCOSIDE (UNII: ICS790225B)
  • POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
  • ASCORBYL PALMITATE (UNII: QN83US2B0N)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • GLYCERYL MONOOLEATE (UNII: C4YAD5F5G6)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
  • BENZYL ALCOHOL (UNII: LKG8494WBH)
  • 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: Nuori Aps
Labeler Code: 72894
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: 06-01-2019 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.

Nuori Mineral Defence Sunscreen Spf 30 Product Label Images

Nuori Mineral Defence 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 Ingredients

Zinc Oxide 23%Purpose: Sunscreen

Uses

  • Helps prevent sunburnHigher 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

Otc - Do Not Use

Do not use on damaged or broken skin.

Otc - Keep Out Of Reach Of Children

Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Otc - When Using

When using this product keep out of eyes. Rinse with water to remove.

Otc - Stop Use

Stop use and ask a doctor if rash occurs.

Directions

  • Apply liberally on clean, moisturized skin 15 minutes before sun exposure.Reapply at least every 2 hours.For daily use, allow product to absorb completely before applying makeup.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 10 a.m.-2 p.m.Wear long-sleeved shirts, pants, hats and sunglasses.Children under 6 months: Ask a doctor.

Inactive Ingredients

Aqua (water), caprylic/capric triglyceride, caprylyl caprylate/caprate, glycerin, silica, arachidyl alcohol, cetearyl alcohol, pongamia glabra (karanja) seed oil, helianthus annuus (sunflower) seed oil, daucus carota sativa (carrot) seed oil, daucus carota sativa (carrot) root extract, pinus pinaster (french maritime pine) bark extract, cetearyl olivate, sorbitan olivate, glyceryl oleate, microcrystalline cellulose, behenyl alcohol, arachidyl glucoside, coco-glucoside, lecithin, polyglyceryl-3 polyricinoleate, hydrogenated palm glycerides citrate, polyhydroxystearic acid, isostearic acid, tocopheryl acetate (vitamin e), ascorbyl palmitate, tocopherol (vitamin e), beta-carotene¹, glucose, xanthan gum, cellulose gum, citric acid, sodium chloride, hydroxyacetophenone, benzyl alcohol.¹ PLANT ORIGIN

Other Information

  • Protect the product in this container from excessive heat and direct sunYou may report a serious adverse reaction to: NUORI Inc., 228 Park Ave S, Ste 300, New York, NY 10003

Questions?

Send them to info@nuori.com

Company Information

MANUFACTURED IN DENMARK FOR NUORI ApSSTORMGADE 35/ DK-1555 COPENHAGENNUORI.COM/ @NUORISKINCARE

Product Packaging

NUORISUNMINERAL DEFENCESUNSCREENHIGH PROTECTIONBROAD SPECTRUM SPF 30UVA & UVBFRESH SKINCARE50ml 1.7fl oz

* Please review the disclaimer below.

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