NDC 49358-563 Mineral Tinted Sunscreen Broad Spectrum Spf 30 Sunscreen Uva-uvb Suncreen

Titanium Dioxide And Zinc Oxide

NDC Product Code 49358-563

NDC Code: 49358-563

Proprietary Name: Mineral Tinted Sunscreen Broad Spectrum Spf 30 Sunscreen Uva-uvb Suncreen 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 And 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

  • 49358 - Mdsolarsciences

NDC 49358-563-01

Package Description: 1 TUBE in 1 CARTON > 17 g in 1 TUBE

NDC Product Information

Mineral Tinted Sunscreen Broad Spectrum Spf 30 Sunscreen Uva-uvb Suncreen with NDC 49358-563 is a a human over the counter drug product labeled by Mdsolarsciences. The generic name of Mineral Tinted Sunscreen Broad Spectrum Spf 30 Sunscreen Uva-uvb Suncreen is titanium dioxide and zinc oxide. The product's dosage form is stick and is administered via topical form.

Labeler Name: Mdsolarsciences

Dosage Form: Stick - A dosage form prepared in a relatively long and slender often cylindrical form.

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.

Mineral Tinted Sunscreen Broad Spectrum Spf 30 Sunscreen Uva-uvb Suncreen 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 .96 g/12g
  • ZINC OXIDE .792 g/12g

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.

  • HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • SHEA BUTTER (UNII: K49155WL9Y)
  • PETROLATUM (UNII: 4T6H12BN9U)
  • BUTYLOCTYL OLEATE (UNII: 2830Y2FNR6)
  • SALICYLIC ACID (UNII: O414PZ4LPZ)
  • ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
  • NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
  • BEHENYL OLIVATE (UNII: NGS1GGK4GW)
  • ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
  • YELLOW WAX (UNII: 2ZA36H0S2V)
  • POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
  • CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
  • BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
  • BENZYLIDENE DIMETHOXYDIMETHYLINDANONE (UNII: 75HIF3C97L)
  • TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
  • FERROSOFERRIC OXIDE (UNII: XM0M87F357)

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: 09-16-2019 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.

Mineral Tinted Sunscreen Broad Spectrum Spf 30 Sunscreen Uva-uvb Suncreen Product Label Images

Mineral Tinted Sunscreen Broad Spectrum Spf 30 Sunscreen Uva-uvb Suncreen 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 IngredientsPurposeTitanium Dioxide 8.25%SunscreenZinc Oxide 6%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

Otc - Do Not Use

Do not use on damaged or broken skin

Otc - Ask Doctor

Stop use and ask a doctor if rash occurs

Otc - When Using

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 exposureReapply:After 80 minutes of swimming or sweatingImmediately after towel dryingAt least every 2 hoursChildren under 6 months: Ask a doctorSun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with Broad Spectrum SPF of 15 or higher and other sun protection 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

Polyethylene, Dimethicone, Butyrospermum Parkii (Shea) Butter, Petrolatum, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Undecylcrylene Dimethicone, Neopentyl Glycol Diheptanoate, Acrylates/Ethylhexyl Acrylate/Dimethicone Methacrylate Copolymer, Behenyl Olivate, Aluminum Hydroxide, Stearic Acid, Glyceryl Isostearate, Beeswax, Polyhydro- xystearic Acid, Cetyl PEG/PPG10/1 Dimeth- icone, BHT, Octyldodec- anol, Iron Oxides, Sorbitan Oleate, Citric Acid Benzylidene Dimethoxydimethylindanone, Tetrahexyldecyl Ascorbate

* Please review the disclaimer below.