NDC 72879-505 Non-nano Sunscreen Spf 40

Zinc Oxide

NDC Product Code 72879-505

NDC Code: 72879-505

Proprietary Name: Non-nano Sunscreen Spf 40 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: Zinc Oxide 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
  • 72879 - Procaps Laboratories, Inc.
    • 72879-505 - Non-nano Sunscreen

NDC 72879-505-02

Package Description: 1 TUBE in 1 BOX > 59 mL in 1 TUBE

NDC 72879-505-04

Package Description: 1 TUBE in 1 BOX > 118 mL in 1 TUBE

NDC 72879-505-06

Package Description: 1 TUBE in 1 BOX > 177 mL in 1 TUBE

NDC Product Information

Non-nano Sunscreen Spf 40 with NDC 72879-505 is a a human over the counter drug product labeled by Procaps Laboratories, Inc.. The generic name of Non-nano Sunscreen Spf 40 is zinc oxide. The product's dosage form is lotion and is administered via topical form.

Labeler Name: Procaps Laboratories, Inc.

Dosage Form: Lotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2

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.


Non-nano Sunscreen Spf 40 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 17.5 g/100mL

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.

  • WATER (UNII: 059QF0KO0R)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • JOJOBA OIL (UNII: 724GKU717M)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • COCO-GLYCERIDES (UNII: ISE9I7DNUG)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • APPLE (UNII: B423VGH5S9)
  • COCOYL PROLINE (UNII: 0IH06971TF)
  • HOPS (UNII: 01G73H6H83)
  • ISOSTEARIC ACID (UNII: X33R8U0062)
  • PHENYLPROPANOL (UNII: 0F897O3O4M)
  • POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
  • XANTHAN GUM (UNII: TTV12P4NEE)

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: Procaps Laboratories, Inc.
Labeler Code: 72879
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: 03-29-2019 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.

Non-nano Sunscreen Spf 40 Product Label Images

Non-nano Sunscreen Spf 40 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 Ingredient

Zinc Oxide 17.5%

Purpose

Sunscreen

Use

  • For external use onlyDo not use on damaged or broken skinWhen 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 a Poison Control Center right away.

Directions

  • For sunscreen useapply liberally and evenly 15minutes before sun exposurereapply at least every 2 hoursuse a water resistant sunscreen if swimming or sweatingimmediately after towel dryingat least every 2 hourschildren under 6 months of age: Ask a doctor.Sun Protection Measures: Spending time in the sun increasesyour 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 measuresincludinglimit time in the sun, especially from 10 a.m.–2 p.m.wear long-sleeved shirts, pants, hats and sunglasses.

Other Information

  • Protect the product in this container from excessive heat and direct sunmay stain some fabrics

Questions?

CALL 800.800.1200www.ProCapsLabs.com

Inactive Ingredients

Water (Aqua), Caprylic/Capric Triglyceride, Simmondsia Chinensis (Jojoba) Seed Oil, Cetearyl Alcohol, Silica, Coco-Glucoside, Microcrystalline Cellulose, Glycerin, Pyrus Malus (Apple) Fruit Extract, Cocoyl Proline, Humulus Lupulus (Hops) Extract, Isostearic Acid, Phenylpropanol, Polyhydroxystearic Acid, Xanthan Gum

* Please review the disclaimer below.

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