NDC 73243-045 You-v Spf-30 Broad Spectrum Sunscreen

Titanium Dioxide, Zinc Oxide

NDC Product Code 73243-045

NDC Code: 73243-045

Proprietary Name: You-v Spf-30 Broad Spectrum 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: Titanium Dioxide, Zinc Oxide 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

  • 73243 - Youv, Llc
    • 73243-045 - You-v Spf-30 Broad Spectrum Sunscreen

NDC 73243-045-03

Package Description: 88 mL in 1 TUBE

NDC Product Information

You-v Spf-30 Broad Spectrum Sunscreen with NDC 73243-045 is a a human over the counter drug product labeled by Youv, Llc. The generic name of You-v Spf-30 Broad Spectrum Sunscreen is titanium dioxide, zinc oxide. The product's dosage form is lotion and is administered via topical form.

Labeler Name: Youv, Llc

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.

You-v Spf-30 Broad Spectrum 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.

  • TITANIUM DIOXIDE 60 mg/mL
  • ZINC OXIDE 35 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.

  • BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
  • WATER (UNII: 059QF0KO0R)
  • ASCORBYL PALMITATE (UNII: QN83US2B0N)
  • YELLOW WAX (UNII: 2ZA36H0S2V)
  • BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • CETEARYL OLIVATE (UNII: 58B69Q84JO)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • COCONUT OIL (UNII: Q9L0O73W7L)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • ETHYL VANILLIN (UNII: YC9ST449YJ)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)
  • PHYMATOLITHON CALCAREUM (UNII: 6J1M3WA0ZK)
  • LINOLEIC ACID (UNII: 9KJL21T0QJ)
  • GREEN OLIVE (UNII: 6HD2W46UEG)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • RASPBERRY (UNII: 4N14V5R27W)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • SORBITAN OLIVATE (UNII: MDL271E3GR)
  • STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

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: Youv, Llc
Labeler Code: 73243
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: 07-22-2019 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.

You-v Spf-30 Broad Spectrum Sunscreen Product Label Images

You-v Spf-30 Broad Spectrum 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

Titanium Dioxide 6.00%Zinc Oxide 3.50%

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:

Do not shine light directly into eyes. 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 immediatly.

Directions:

  • Apply liberally 15 minutes before sun exposure.Use light to reveal where sunscreen is applied.For best results, use light indoors or in shade.Reapply: At least every two-hours and Immediately after swimming, sweating or towel drying.
  • Sun Protection Measures: Spending 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:

Acrylates Copolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aluminum Hydroxide, Aqua (Deionized Water), Ascorbyl Palmitate (Vitamin C), Beeswax, Bis(glycidoxyphenyl) Propane/Aminomethyl Norbornane Copolymer, Butyloctyl Salicylate, Caprylic/Capric Triglyceride, Carica Papaya Fruit Extract, Cetearyl Olivate, Cetyl Alcohol, Cocos Nucifera (Coconut) Oil, Dimethicone, Ethyl Vanillin, Ethylhexylglycerin, Flourescent Brightener 230, Glycerin, Glyceryl Stearate, Helianthu Annuus (Sunflower) Oil, Laminaria (Algae) Extract, Linoleic Acid, Olea Europaca (Olive) Oil, Phenoxyethanol, Polysorbate-20, Rubus Idaeus (Raspberry) Extract, Sodium Hydroxide, Sorbitan Olivate, Stearyl Alcohol, Tocopheryl Acetate (Vitamin E)

Other Information:

Protect this product from excessive heat & direct sunlight

Questions?

Visit: youvsunscreen.com Manufactured by YouV LLC

* Please review the disclaimer below.

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