NDC 58416-003 Nelly Devuyst Mineral Spf 30 Sunscreen

Sunscreen

NDC Product Code 58416-003

NDC Code: 58416-003

Proprietary Name: Nelly Devuyst Mineral Spf 30 Sunscreen Additional informationCallout TooltipWhat 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: Sunscreen Additional informationCallout TooltipWhat 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.


Code Structure
  • 58416 - 7774672 Canada Inc
    • 58416-003 - Nelly Devuyst Mineral Spf 30 Sunscreen

NDC 58416-003-00

Package Description: 1 BOTTLE, PLASTIC in 1 BOX > 120 g in 1 BOTTLE, PLASTIC

NDC Product Information

Nelly Devuyst Mineral Spf 30 Sunscreen with NDC 58416-003 is a a human over the counter drug product labeled by 7774672 Canada Inc. The generic name of Nelly Devuyst Mineral Spf 30 Sunscreen is sunscreen. The product's dosage form is cream and is administered via topical form.

Labeler Name: 7774672 Canada 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 Additional informationCallout TooltipWhat 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.


Nelly Devuyst Mineral Spf 30 Sunscreen Active Ingredient(s)

Additional informationCallout TooltipWhat 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 18.4 g/g
  • TITANIUM DIOXIDE 2 g/g

Inactive Ingredient(s)

Additional informationCallout TooltipAbout 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.

  • TOCOPHEROL (UNII: R0ZB2556P8)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • SALICYLIC ACID (UNII: O414PZ4LPZ)
  • ALOE (UNII: V5VD430YW9)
  • C10-18 TRIGLYCERIDES (UNII: 43AGM4PHPI)
  • CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9)
  • PROPANEDIOL (UNII: 5965N8W85T)
  • COCO-CAPRYLATE (UNII: 4828G836N6)
  • POLYGLYCERYL-6 DISTEARATE (UNII: Z35I17EQOP)
  • ISOSTEARIC ACID (UNII: X33R8U0062)
  • LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)
  • POLYGLYCERYL-3 OLEATE (UNII: XRQ165498B)
  • POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
  • GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
  • SODIUM CITRATE (UNII: 1Q73Q2JULR)
  • HYALURONATE SODIUM (UNII: YSE9PPT4TH)
  • PANAX GINSENG ROOT OIL (UNII: P9T4K47OM0)
  • ACMELLA OLERACEA FLOWER (UNII: 2794N5KM0K)
  • FAGUS SYLVATICA FLOWER BUD (UNII: 6D5V13045W)
  • ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)
  • WITHANIA SOMNIFERA ROOT (UNII: V038D626IF)
  • FRUCTOSE (UNII: 6YSS42VSEV)
  • JOJOBA OIL GLYCERETH-8 ESTERS (UNII: 435WC6V33R)
  • KAOLIN (UNII: 24H4NWX5CO)
  • SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • SORBIC ACID (UNII: X045WJ989B)
  • WATER (UNII: 059QF0KO0R)
  • BENZYL ALCOHOL (UNII: LKG8494WBH)
  • BENZALDEHYDE (UNII: TA269SD04T)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • ALUMINUM OXIDE (UNII: LMI26O6933)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)

Administration Route(s)

Additional informationCallout TooltipWhat 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

Additional informationCallout TooltipWhat is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: 7774672 Canada Inc
Labeler Code: 58416
FDA Application Number: part352 Additional informationCallout TooltipWhat 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. Additional informationCallout TooltipWhat 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: 01-27-2019 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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.

Nelly Devuyst Mineral Spf 30 Sunscreen Product Label Images

Nelly Devuyst Mineral Spf 30 Sunscreen 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

Titanium Dioxide (Non-Nano) 2%Zinc Oxide 18.4%

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 ask a doctor if rash occurs.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact Poison Control Center right away.

Directions

■ apply liberally 15 minutes before exposure, reapply: after 80 minutes of swimming or sweating immediately after towel drying at least every 2 hours.■
Sun Protection Measures: spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the 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 of age: ask a doctor.

Inactive Ingredients

Aloe Barbadensis Leaf Juice*, C10-18 Triglycerides, Caprylic/Capric Triglyceride, Propanediol, Coco-Caprylate, Polyglyceryl-6 Distearate, Isostearic Acid, Lecithin, Polyglyceryl-3 Polyricinoleate, Polyhydroxystearic Acid, Glyceryl Stearate, Sodium Citrate, Sodium Hyaluronate, Panax Ginseng Root Extract*, Acmella Oleracea Extract, Fagus Sylvatica Bud Extract, Ascorbyl Glucoside, Withania Somnifera Root Extract, Fructose, Jojoba Esters, Kaolin, Sodium Stearoyl Glutamate, Xanthan Gum, Salicylic Acid, Polyglyceryl-3 Beeswax, Cetyl Alcohol, Glycerin, Tocopherol, Aroma, Benzyl Alcohol, Potassium Sorbate, Alumina, Stearic Acid, Sorbic Acid, Water (Aqua).*Certified Organic

Distributed By:

7774672 Canada IncDerme & Co4980 Chemin Bois FrancSt Laurent QC H4S 1A7CanadaMADE IN CANADA

* Please review the disclaimer below.

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