NDC 64127-234 Gm Collin Spf 25 Uva - Uvb Urban Protection Veil Sunscreen

Zinc Oxide And Titanium Dioxide

  1. Labeler Index
  2. Laboratoires Dermo Cosmetik Inc
  3. NDC: 64127-234 Gm Collin Spf 25 Uva - Uvb Urban Protection Veil Sunscreen

NDC Product Code 64127-234

NDC CODE: 64127-234

Proprietary Name: Gm Collin Spf 25 Uva - Uvb Urban Protection Veil Sunscreen 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: Zinc Oxide And Titanium Dioxide 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.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.
  • This medication is used to treat and prevent diaper rash and other minor skin irritations (e.g., burns, cuts, scrapes). It works by forming a barrier on the skin to protect it from irritants/moisture.

NDC Code Structure

  • 64127 - Laboratoires Dermo Cosmetik Inc

NDC 64127-234-01

Package Description: 1 BOTTLE, PLASTIC in 1 BOX > 100 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Gm Collin Spf 25 Uva - Uvb Urban Protection Veil Sunscreen with NDC 64127-234 is a a human over the counter drug product labeled by Laboratoires Dermo Cosmetik Inc. The generic name of Gm Collin Spf 25 Uva - Uvb Urban Protection Veil Sunscreen is zinc oxide and titanium dioxide. The product's dosage form is cream and is administered via topical form.

Labeler Name: Laboratoires Dermo Cosmetik 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 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.

Gm Collin Spf 25 Uva - Uvb Urban Protection Veil Sunscreen 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.
  • ZINC OXIDE 14.6 mg/100mL
  • TITANIUM DIOXIDE 4.2 mg/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.
  • 1,2-HEXANEDIOL (UNII: TR046Y3K1G)
  • ALUMINUM OXIDE (UNII: LMI26O6933)
  • WATER (UNII: 059QF0KO0R)
  • ARGAN OIL (UNII: 4V59G5UW9X)
  • ASCORBYL PALMITATE (UNII: QN83US2B0N)
  • LEVOMENOL (UNII: 24WE03BX2T)
  • ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
  • FARNESOL (UNII: EB41QIU6JL)
  • ISODECYL LAURATE (UNII: 254BX4O0JU)
  • MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
  • NEOPENTYL GLYCOL DIETHYLHEXANOATE (UNII: U68ZV6W62C)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • POLYGLYCERYL-6 POLYRICINOLEATE (UNII: YPM0ZOC2HR)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • PROPANEDIOL DICAPRYLATE (UNII: C577OMC6UH)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)

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.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Laboratoires Dermo Cosmetik Inc
Labeler Code: 64127
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: 01-15-2021 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: 12-31-2022 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’.

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Gm Collin Spf 25 Uva - Uvb Urban Protection Veil Sunscreen Product Label Images

Gm Collin Spf 25 Uva - Uvb Urban Protection Veil 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

Product Facts / Drug Facts

DISTRIBUTED BY:® LABORATOIRES DERMO-COSMETIK INC.68 STINSON, MONTREAL, QUEBEC, CANADA H4N 2E7

Otc - Purpose

Active ingredients:PurposeZinc Oxide 13.3%SunscreenTitanium Dioxide 3.8%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. Shake well before each use.

Otc - Do Not Use

Do not use on damaged or broken skin.

Otc - When Using

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

Otc - Stop Use

Stop use and ask a doctor if rash occurs.

Otc - Keep Out Of Reach Of Children

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

Directions

  • Adults over 18 years old:apply liberally 15 minutes before sun exposure.reapply at least every 2 hoursuse a water-resistant sunscreen if swimming or sweatingSun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease 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.

Other Information

  • Protect this product from excessive heat and direct sun.keep at room temperature (15 - 30°C / 59 - 86°F)

Inactive Ingredients

1,2-HEXANEDIOL, ALUMINA, AQUA/WATER/EAU, ARGANIA SPINOSA KERNEL OIL, ASCORBYL PALMITATE, BISABOLOL, C12-15 ALKYL BENZOATE, FARNESOL, FRAGRANCE/PARFUM, HYDROGEN DIMETHICONE, ISODECYL LAURATE, MAGNESIUM SULFATE, NEOPENTYL GLYCOL DIETHYLHEXANOATE, PHENOXYETHANOL, POLYGLYCERYL-6 POLYHYDROXYSTEARATE, POLYGLYCERYL-6 POLYRICINOLEATE, POLYHYDROXYSTEARIC ACID, POTASSIUM SORBATE, PROPANEDIOL DICAPRYLATE, TOCOPHEROL, TOCOPHERYL ACETATE, TRIETHOXYCAPRYLYLSILANE.

Questions?

USA: 1 (800) 341-1531 / CANADA: 1 (800) 361-1263

* Please review the disclaimer below.