NDC 41250-883 7-in-1 Anti-aging Vitamin Moisturizer Broad Spectrum Spf15 Sunscreen

Avobenzone, Homosalate, Octisalate, Octocrylene

NDC Product Code 41250-883

NDC Code: 41250-883

Proprietary Name: 7-in-1 Anti-aging Vitamin Moisturizer Broad Spectrum Spf15 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: Avobenzone, Homosalate, Octisalate, Octocrylene 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

  • 41250 - Meijer Distribution Inc
    • 41250-883 - 7-in-1 Anti-aging Vitamin Moisturizer Broad Spectrum Spf15 Sunscreen

NDC 41250-883-50

Package Description: 50 mL in 1 BOTTLE

NDC Product Information

7-in-1 Anti-aging Vitamin Moisturizer Broad Spectrum Spf15 Sunscreen with NDC 41250-883 is a a human over the counter drug product labeled by Meijer Distribution Inc. The generic name of 7-in-1 Anti-aging Vitamin Moisturizer Broad Spectrum Spf15 Sunscreen is avobenzone, homosalate, octisalate, octocrylene. The product's dosage form is cream and is administered via topical form.

Labeler Name: Meijer Distribution 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.

7-in-1 Anti-aging Vitamin Moisturizer Broad Spectrum Spf15 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.

  • AVOBENZONE 30 mg/mL
  • HOMOSALATE 40 mg/mL
  • OCTISALATE 45 mg/mL
  • OCTOCRYLENE 26 mg/mL

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)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • ISOPROPYL ISOSTEARATE (UNII: C67IXB9Y7T)
  • NIACINAMIDE (UNII: 25X51I8RD4)
  • POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
  • STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • DOCOSANOL (UNII: 9G1OE216XY)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
  • PANTHENOL (UNII: WV9CM0O67Z)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • BENZYL ALCOHOL (UNII: LKG8494WBH)
  • CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • ZINC OXIDE (UNII: SOI2LOH54Z)
  • TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
  • EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
  • PEG-100 STEARATE (UNII: YD01N1999R)
  • BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • GREEN TEA LEAF (UNII: W2ZU1RY8B0)

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: Meijer Distribution Inc
Labeler Code: 41250
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: 06-18-2019 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: 12-31-2020 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.

7-in-1 Anti-aging Vitamin Moisturizer Broad Spectrum Spf15 Sunscreen Product Label Images

7-in-1 Anti-aging Vitamin Moisturizer Broad Spectrum Spf15 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

Active Ingredients

Avobenzone, 3.0%Homosalate, 4.0%Octisalate, 4.5%Octocrylene, 2.6 %

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 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

• apply liberally 15 minutes before sun exposure


• reapply at least every 2 hours


• use water resistant sunscreen if swimming or sweating


• children under 6 months of age: ask a doctor





Sun 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 10 a.m. – 2 p.m.


• wear long-sleeved shirts, pants, hats and sunglasses.

Other Information

• protect the product in this container from excessive hear and direct sun

Inactive Ingredients

Water, Glycerin, Isopropyl Isostearate, Niacinamide, PTFE, Cetearyl Alcohol, Cetearyl Glucoside, Stearyl Alcohol, Dimethicone, Phenoxyethanol, Ethylhexylglycerin, Dimethiconol, Behenyl Alcohol, Cetyl Alcohol, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Panthenol (ProVitamin B5), Tocopheryl Acetate (Vitamin E), Stearic Acid, Benzyl Alcohol, Carbomer, Silica, Stearic Acid, Titanium Dioxide, Zinc Oxide, Triethoxycaprylylsilane, Disodium EDTA, PEG-100 Stearate, BHT, Sodium Hydroxide, Camellia Sinensis Leaf Extract.

* Please review the disclaimer below.