NDC 58331-050 Croc Bloc Broad Spectrum Spf 50 Fps Ecran Solaire

Homosalate, Octisalate, Octocrylene, Oxybenzone, And Avobenzone

NDC Product Code 58331-050

NDC CODE: 58331-050

Proprietary Name: Croc Bloc Broad Spectrum Spf 50 Fps Ecran Solaire 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: Homosalate, Octisalate, Octocrylene, Oxybenzone, And Avobenzone 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

NDC 58331-050-01

Package Description: 120 mL in 1 BOTTLE, PLASTIC

NDC 58331-050-02

Package Description: 10 mL in 1 PACKET

NDC 58331-050-03

Package Description: 750 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Croc Bloc Broad Spectrum Spf 50 Fps Ecran Solaire with NDC 58331-050 is a a human over the counter drug product labeled by Degil Safety Products (1989) Inc.. The generic name of Croc Bloc Broad Spectrum Spf 50 Fps Ecran Solaire is homosalate, octisalate, octocrylene, oxybenzone, and avobenzone. The product's dosage form is lotion and is administered via topical form.

Labeler Name: Degil Safety Products (1989) 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 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.

Croc Bloc Broad Spectrum Spf 50 Fps Ecran Solaire 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.

  • OCTOCRYLENE 7 g/100mL
  • AVOBENZONE 3 g/100mL
  • OXYBENZONE 4 g/100mL
  • OCTISALATE 5 g/100mL
  • HOMOSALATE 13 g/100mL

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.

  • WATER (UNII: 059QF0KO0R)
  • SORBITOL (UNII: 506T60A25R)
  • ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
  • POLYGLYCERYL-3 DISTEARATE (UNII: ZI1LK470XV)
  • BENZYL ALCOHOL (UNII: LKG8494WBH)
  • DIMETHICONE 1000 (UNII: MCU2324216)
  • CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)

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.
  • 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: Degil Safety Products (1989) Inc.
Labeler Code: 58331
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: 02-18-2020 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: 12-31-2021 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.

Croc Bloc Broad Spectrum Spf 50 Fps Ecran Solaire Product Label Images

Croc Bloc Broad Spectrum Spf 50 Fps Ecran Solaire 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

  • May stain or damage some fabrics or surfaces.

Otc - Purpose

ActiveIngredientsPurposesHomosalate13.0 % w/wSunscreenOctocrylene  7.0 % w/wSunscreenOctisalate  5.0 % w/wSunscreenOxybenzone  4.0 % w/wSunscreenAvobenzone  3.0 % w/wSunscreen

Uses

  • Helps prevent sunburn

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 reach of children

When Using This Product

  • Avoid contact with eyes. Rinse with water to remove.

Stop Use And Ask Doctor If

  • Rash or irritation develops and lasts

Directions

  • Apply liberally and evenly to dry skin 15 minutes before exposure to the sun. Reapply every 2 hours to insure adequate UV protection or 80 minutes after swimming, perspiring heavily, or immediately after washing and towel drying.For children under 6 months of age: Ask a doctor

Other Information

  • Protect the product from excessive heat and direct sun

Inactive Ingredients

Aqua, Sorbitol, Aluminum Starch Octenylsuccinate VP/Eicosene Copolymer, Stearic Acid, Triethanolamine, Sorbitan Isostearate, Benzyl Alcohol, Dimethicone, Tocopherol, Polyglyceryl-3 Distearate, Methylparaben, Carbomer, Propylparaben, Disodium EDTA.

* Please review the disclaimer below.