NDC 49358-566 Hydrating Sheer Lip Balm Spf 30 - Nude Broad Spectrum Spf 30 Uva-uvb Sunscreen

Avobenzone, Octisalate, And Homosalate

NDC Product Code 49358-566

NDC Code: 49358-566

Proprietary Name: Hydrating Sheer Lip Balm Spf 30 - Nude Broad Spectrum Spf 30 Uva-uvb 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, Octisalate, And Homosalate 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

  • 49358 - Mdsolarsciences
    • 49358-566 - Hydrating Sheer Lip Balm Spf 30 - Nude

NDC 49358-566-01

Package Description: 1 APPLICATOR in 1 CARTON > 4.2 g in 1 APPLICATOR

NDC Product Information

Hydrating Sheer Lip Balm Spf 30 - Nude Broad Spectrum Spf 30 Uva-uvb Sunscreen with NDC 49358-566 is a a human over the counter drug product labeled by Mdsolarsciences. The generic name of Hydrating Sheer Lip Balm Spf 30 - Nude Broad Spectrum Spf 30 Uva-uvb Sunscreen is avobenzone, octisalate, and homosalate. The product's dosage form is lipstick and is administered via topical form.

Labeler Name: Mdsolarsciences

Dosage Form: Lipstick - A waxy solid, usually colored cosmetic, in stick form for the lips.

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.

Hydrating Sheer Lip Balm Spf 30 - Nude Broad Spectrum Spf 30 Uva-uvb 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/g
  • OCTISALATE 50 mg/g
  • HOMOSALATE 100 mg/g

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: Mdsolarsciences
Labeler Code: 49358
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 FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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: 10-01-2019 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.

Hydrating Sheer Lip Balm Spf 30 - Nude Broad Spectrum Spf 30 Uva-uvb Sunscreen Product Label Images

Hydrating Sheer Lip Balm Spf 30 - Nude Broad Spectrum Spf 30 Uva-uvb 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

Drug Facts

Distributed by: MDSolarSciences Corp, Stamford, CT 06902

Otc - Purpose

Active IngredientsPurposeAvobenzone 2%SunscreenOctisalate 5%SunscreenHomosalate 10%Sunscreen

Uses

  • Helps prevent sunburnIf 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. Stop use and ask a doctor if rash occurs. When using this product keep out of eyes. Rinse with water to remove.

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

  • Apply liberally 15 minutes before sun exposure & again after swimming or sweating.Reapply at least every 2 hours.Children under 6 months: Ask a doctorSun Protection Measures: To decrease your risk of skin cancer and early skin aging, regularly use a sunscreen of SPF15 or higher and other sun protective measures including:Limit time in the sun, especially from 10a.m.-2p.m.Wear long-sleeved shirts, pants, hats and sunglasses

Other Information

  • Protect the product in this container from excessive heat and direct sunlightYou may report serious adverse reactions to: Report Reaction, LLC. PO Box 22, Plainsboro, NJ 08536-0222

Inactive Ingredients

Persea Gratissima (Avocado) Oil, Butyrospermum Parkii (Shea) Butter, Paraffin Wax, Hydrogenated Soybean Oil, Ricinus Communis (Castor) Seed Oil, Octyldodecanol, Olea Europaea (Olive) Fruit Oil, Jojoba Esters, Hydrogenated Vegetable Oil, Microcrystalline Wax, Stearic Acid, Helianthus Annuus (Sunflower) Seed Oil, Squalane, Acacia Decurrens Flower Wax, Polyglycerin-3, Rhus Verniciflua Peel Wax, Sorbitan Oleate, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Ascorbyl Palmitate, Tocopherol. May contain: Titanium Dioxide (CI 77891), Iron Oxides (CI 77491- Red), Iron Oxides (CI 77492 - Yellow), Iron Oxides (CI 77499 - Black) CI 19140 - Yellow 5, Red 28 Lake (CI 45410)

* Please review the disclaimer below.