NDC 72872-891 Mormaii Grip Action Protector Solar

Octinoxate, Octisalate, Octocrylene, Avobenzone

NDC Product Code 72872-891

NDC Code: 72872-891

Proprietary Name: Mormaii Grip Action Protector Solar 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: Octinoxate, Octisalate, Octocrylene, Avobenzone 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
  • 72872 - Alfa Hosting Distribuicao E Importacao De Medicamentos E Alimentos Eireli
    • 72872-891 - Mormaii Grip Action Protector Solar

NDC 72872-891-40

Package Description: 100 mL in 1 TUBE

NDC Product Information

Mormaii Grip Action Protector Solar with NDC 72872-891 is a a human over the counter drug product labeled by Alfa Hosting Distribuicao E Importacao De Medicamentos E Alimentos Eireli. The generic name of Mormaii Grip Action Protector Solar is octinoxate, octisalate, octocrylene, avobenzone. The product's dosage form is cream and is administered via topical form.

Labeler Name: Alfa Hosting Distribuicao E Importacao De Medicamentos E Alimentos Eireli

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.


Mormaii Grip Action Protector Solar 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.

  • OCTINOXATE 75 mg/mL
  • OCTISALATE 50 mg/mL
  • OCTOCRYLENE 50 mg/mL
  • AVOBENZONE 30 mg/mL

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.

  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • WATER (UNII: 059QF0KO0R)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • COCONUT OIL (UNII: Q9L0O73W7L)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • PEG-100 STEARATE (UNII: YD01N1999R)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • CORN (UNII: 0N8672707O)
  • PROPANEDIOL (UNII: 5965N8W85T)

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: Alfa Hosting Distribuicao E Importacao De Medicamentos E Alimentos Eireli
Labeler Code: 72872
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: 02-01-2019 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.

Mormaii Grip Action Protector Solar Product Label Images

Mormaii Grip Action Protector Solar 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

Octinoxate 7.50%Octisalate 5.00%Octocrylene 5.00%Avobenzone 3.00%

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 Consult Physician

If irritation or rash develops.

Keep Out Of Reach Of Children.

If product is swallowed, get medical attention or contact poison control center immediately.

Directions:

* Apply liberally 15-minutes before use exposure.* Reapply: -At least every two-hours.-Immediately after swimming, sweating or towel drying.SUN PROTECTION MEASURES: Spening time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use sunscreen with broad spectrum protection and an SPF rating of 15 or higher, along with other sun protection measures including:-Limit time in the sun, especially between 10am and 2pm.-Wear long sleeve shirts, pants, hats and sunglasses.-For children under 6-months, consult a physician.

Other Ingredients:

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Cetyl Alcohol, Citric Acid, Cocos Nucifera (Coconut) Oil, Ethylhexylglycerin, Glyceryl stearate, Helianthus Annuus (Sunflower) Oil, PEG-100 stearate, Phenoxyethanol, Polysorbate-80, styrene/Acrylates Copolymer, Tocopheryl Acetate (Vitamin E), Zemea (Corn) Propanediol.

Other Information:

*Protect this product from excessive heat and direct sunlight.

* Please review the disclaimer below.

Previous Code
72868-010
Next Code
72875-0001