NDC 58666-0548 Shea Moisture Gotu Kola And Raspberry Seed Oil Broad Spectrum Spf 25 Daily Sunscreen

Zinc Oxide

NDC Product Code 58666-0548

NDC Code: 58666-0548

Proprietary Name: Shea Moisture Gotu Kola And Raspberry Seed Oil Broad Spectrum Spf 25 Daily 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: 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
  • 58666 - Sundial Group Llc
    • 58666-0548 - Shea Moisture Gotu Kola And Raspberry Seed Oil Broad Spectrum Spf 25 Daily Sunscreen

NDC 58666-0548-4

Package Description: 177 mL in 1 TUBE

NDC Product Information

Shea Moisture Gotu Kola And Raspberry Seed Oil Broad Spectrum Spf 25 Daily Sunscreen with NDC 58666-0548 is a a human over the counter drug product labeled by Sundial Group Llc. The generic name of Shea Moisture Gotu Kola And Raspberry Seed Oil Broad Spectrum Spf 25 Daily Sunscreen is zinc oxide. The product's dosage form is cream and is administered via topical form.

Labeler Name: Sundial Group Llc

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.


Shea Moisture Gotu Kola And Raspberry Seed Oil Broad Spectrum Spf 25 Daily 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 18.75 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.

  • .BETA.-SITOSTEROL (UNII: S347WMO6M4)
  • GLYCERYL LINOLENATE (UNII: SGB6X4G86K)
  • SUNFLOWER OIL (UNII: 3W1JG795YI)
  • YELLOW WAX (UNII: 2ZA36H0S2V)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • RASPBERRY SEED OIL (UNII: 9S8867952A)
  • CARROT SEED OIL (UNII: 595AO13F11)
  • SQUALENE (UNII: 7QWM220FJH)
  • CENTELLA ASIATICA (UNII: 7M867G6T1U)

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: Sundial Group Llc
Labeler Code: 58666
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: 01-28-2019 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.

Shea Moisture Gotu Kola And Raspberry Seed Oil Broad Spectrum Spf 25 Daily Sunscreen Product Label Images

Shea Moisture Gotu Kola And Raspberry Seed Oil Broad Spectrum Spf 25 Daily 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

Other

Drug Facts

Active Ingredient

Zinc Oxide 18.75%

Purpose

Sunscreen

Uses

  • Helps prevent sunburnIf 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 onlySun 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 10am-2pmWear long-sleeved shirts, pants, hats, and sunglassesChildren under 6 months of age: ask a doctor.

Otc - Do Not Use

Do not use on damaged or broken skin.

Otc - Stop Use

Stop and ask a doctor if rash occurs.

Otc - When Using

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

Otc - Keep Out Of Reach Of Children

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

Directions

  • Apply generously and evenly 15 minutes before sun exposure.Apply to all skin exposed to the sun.Reapply:After swimming or sweatingImmediately after towel dryingAt least every 2 hours

Ingredients

Hellianthus Annuus (Sunflower) Seed Oil, Beeswax, Glyceryl Linolenate, Tocopherol, Beta-Sitosterol, Squalene, Daucus Carota Sativa (Carrot) Seed Oil, Daucus Carota Sativa (Carrot) Seed Oil, Rubus Idaeus (Raspberry) Seed Oil, Centella Asiatica Extract

Other Information

Protect this product from excessive heat and direct sun.

Questions?

Questions? 631-842-8800 or visit www.SheaMoisture.com

* Please review the disclaimer below.

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