NDC 73291-0002 Sunbetter Broad Spectrum Spf 56 Sunscreen Stick Sheer

Zinc Oxide, Titanium Dioxide

NDC Product Code 73291-0002

NDC Code: 73291-0002

Proprietary Name: Sunbetter Broad Spectrum Spf 56 Sunscreen Stick Sheer 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: Zinc Oxide, Titanium Dioxide 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

  • 73291 - Skinbetter Science Llc

NDC 73291-0002-1

Package Description: 20 g in 1 CONTAINER

NDC 73291-0002-2

Package Description: 6 g in 1 CONTAINER

NDC Product Information

Sunbetter Broad Spectrum Spf 56 Sunscreen Stick Sheer with NDC 73291-0002 is a a human over the counter drug product labeled by Skinbetter Science Llc. The generic name of Sunbetter Broad Spectrum Spf 56 Sunscreen Stick Sheer is zinc oxide, titanium dioxide. The product's dosage form is stick and is administered via topical form.

Labeler Name: Skinbetter Science Llc

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.

Sunbetter Broad Spectrum Spf 56 Sunscreen Stick Sheer 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 50 mg/g
  • ZINC OXIDE 100 mg/g

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.

  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • CERIC OXIDE (UNII: 619G5K328Y)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • HEXYLDECANOL (UNII: 151Z7P1317)
  • DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
  • OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
  • DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
  • ALUMINUM OXIDE (UNII: LMI26O6933)
  • RAPESEED STEROL (UNII: B46B6DD20U)
  • BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
  • CETYLHYDROXYPROLINE PALMITAMIDE (UNII: 74ONU0S62G)
  • LAURETH-25 (UNII: RPD53041LR)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
  • PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
  • HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • .ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)
  • VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)
  • 1,2-HEXANEDIOL (UNII: TR046Y3K1G)
  • DIMETHICONE METHACRYLATE (3000 MW) (UNII: LO1KC6D3D5)
  • HIMANTHALIA ELONGATA (UNII: 21RND18XRR)
  • CORN OIL (UNII: 8470G57WFM)
  • LAURETH-3 (UNII: F32E4CB0UJ)
  • CERESIN (UNII: Q1LS2UJO3A)
  • PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)
  • POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
  • APRICOT KERNEL OIL (UNII: 54JB35T06A)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • TRIBEHENIN (UNII: 8OC9U7TQZ0)
  • WATER (UNII: 059QF0KO0R)
  • GINGER (UNII: C5529G5JPQ)
  • .ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)

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: Skinbetter Science Llc
Labeler Code: 73291
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: 09-17-2019 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.

Sunbetter Broad Spectrum Spf 56 Sunscreen Stick Sheer Product Label Images

Sunbetter Broad Spectrum Spf 56 Sunscreen Stick Sheer 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

Drug Facts

Drug Facts

Active Ingredients

Titanium Dioxide 5.0%Zinc Oxide 10.0%

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 prodoct is swallowed, get medical help or contact a poison control center right away.

Directions

  • Apply liberally and evenly 15 minutes before sun exposure. Reapply: after 80 minutes of swimming or sweating. immediately after towel drying. at least every 2 hours.Sun Protection Measures. Spending time in the sun ircreases 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. Children under 6 months: Ask a doctor.

Inactive Ingredients

1,2-Hexanediol, Acrylates/Dimethicone Copolymer, Alumina, Bis-Vinyl Dimethicone/Dimethicone Copolymer, Bisabolol, Brassica Campestris (Rapeseed) Sterols, Butyloctyl Salicylate, Caprylic/Capric Triglyceride, Caprylyl Glycol, Cerium Oxide, Cetylhydroxyproline Palmitamide, Dimethicone, Dimethicone/Vinyl Dimethicone Crosspolymer, Disteardimonium Hectorite, Ethylhexylglycerin, Hexyldecanol, Himanthalia Elongata Extract, Hydrogenated Vegetable Oil, Laureth-25, Laureth-3, Octyldodecyl Neopentanoate, Ozokerite, Phenethyl Alcohol, Phenoxyethanol, Phenyl Trimethicone, Plankton Extract, Polyethylene, Polyhydroxystearic Acid, Polymethyl Methacrylate, Prunus Armeniaca (Apricot) Kernel Oil, Silica, Simethicone, Sodium Chloride, Stearic Acid, Tocopherol, Tocopheryl Acetate, Tribehenin, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Water, Zingiber Officinale (Ginger) Root Extract.

Other Information

Protect this product from excessive heat and direct sun.

* Please review the disclaimer below.