NDC 73572-001 Personalized Day Moisturizer With Spf

Homosalate, Octocrylene, Zinc Oxide

NDC Product Code 73572-001

NDC 73572-001-30

Package Description: 30 mL in 1 BOTTLE

NDC Product Information

Personalized Day Moisturizer With Spf with NDC 73572-001 is a a human over the counter drug product labeled by Proven Skincare. The generic name of Personalized Day Moisturizer With Spf is homosalate, octocrylene, zinc oxide. The product's dosage form is cream and is administered via topical form.

Labeler Name: Proven Skincare

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.

Personalized Day Moisturizer With Spf 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.

  • HOMOSALATE 150 mg/mL
  • OCTOCRYLENE 100 mg/mL
  • ZINC OXIDE 80 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)
  • AVOBENZONE (UNII: G63QQF2NOX)
  • SQUALANE (UNII: GW89575KF9)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
  • ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
  • CETEARETH-6 OLIVATE (UNII: 8834VWF9MO)
  • CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
  • MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • WATERMELON (UNII: 231473QB6R)
  • CITRULLINE (UNII: 29VT07BGDA)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • CERAMIDE 3 (UNII: 4370DF050B)
  • GLUTATHIONE (UNII: GAN16C9B8O)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • HYALURONIC ACID (UNII: S270N0TRQY)
  • PENTYLENE GLYCOL (UNII: 50C1307PZG)
  • PROPANEDIOL (UNII: 5965N8W85T)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
  • FERULIC ACID (UNII: AVM951ZWST)
  • XANTHAN GUM (UNII: TTV12P4NEE)

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: Proven Skincare
Labeler Code: 73572
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: 03-01-2020 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.

Personalized Day Moisturizer With Spf Product Label Images

Personalized Day Moisturizer With Spf 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

Homosalate 15%Octocrylene 10%Zinc Oxide 8%

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 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 Using 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. Works best on moisturized skin. Reapply: After swimming or sweating Immediately after towel drying.Children under 6 months of age: Ask a doctor. Use water resistant sunscreen if swimming or sweating.Sun Protection Measures Spending time in the sun increases your risk of skin cancer and early skin ageing. 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.

Inactive Ingredients

Water, Avobenzone, Squalane, Cetearyl Alcohol, Ceteareth-20, C12-15 Alkyl Benzoate, CETEARETH-6 OLIVATE, Butyl Methoxydibenzoylmethane, Cyclopentasiloxane, Magnesium Ascorbyl Phosphate, Glycerin, Citrullus Lanatus (Watermelon) Fruit Extract (and) Citrulline (and) Glycerin (and) Aqua (and) Phenoxyethanol (and) Sodium Benzoate (and) Potassium Sorbate, Ceramide 3, Glutathione, Dimethicone, Hyaluronic acid, Pentylene Glycol, 1,3 Propanediol, Caprylyl Glycol, Ethlhexyl Glycerin, Panax Ginseng Extract, Calendula Officinalis Flower Extract, Ferulic acid, Xanthan Gum, Essential oils blend

Other Information

  • Protect this product from excessive heat and direct sun.

* Please review the disclaimer below.