NDC 73291-0004 Sunbetter Broad Spectrum Spf 70 Sunscreen Sheer

Zinc Oxide, Titanium Dioxide

NDC Product Code 73291-0004

NDC 73291-0004-1

Package Description: 50 mL in 1 BOTTLE, PUMP

NDC 73291-0004-2

Package Description: 15 mL in 1 BOTTLE, PUMP

NDC 73291-0004-3

Package Description: 1 mL in 1 PACKET

NDC Product Information

Sunbetter Broad Spectrum Spf 70 Sunscreen Sheer with NDC 73291-0004 is a a human over the counter drug product labeled by Skinbetter Science Llc. The generic name of Sunbetter Broad Spectrum Spf 70 Sunscreen Sheer is zinc oxide, titanium dioxide. The product's dosage form is lotion and is administered via topical form.

Labeler Name: Skinbetter Science 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.

Sunbetter Broad Spectrum Spf 70 Sunscreen 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.

  • ZINC OXIDE 100 mg/mL
  • TITANIUM DIOXIDE 36 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.

  • MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)
  • NIACINAMIDE (UNII: 25X51I8RD4)
  • BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
  • POLYGLYCERYL-4 OLEATE (UNII: 15B05TY4GX)
  • 1,2-HEXANEDIOL (UNII: TR046Y3K1G)
  • ALUMINUM OXIDE (UNII: LMI26O6933)
  • HIMANTHALIA ELONGATA (UNII: 21RND18XRR)
  • PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)
  • CERIC OXIDE (UNII: 619G5K328Y)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • WATER (UNII: 059QF0KO0R)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • CETYL DIMETHICONE 45 (UNII: IK315POC44)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
  • .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
  • POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
  • DODECAMETHYLPENTASILOXANE (UNII: 0QDQ2VQ5YJ)
  • STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • SQUALANE (UNII: GW89575KF9)
  • POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
  • PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
  • .ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC)
  • PANTHENOL (UNII: WV9CM0O67Z)

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: 02-01-2021 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: 12-31-2022 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 70 Sunscreen Sheer Product Label Images

Sunbetter Broad Spectrum Spf 70 Sunscreen 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 3.6%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 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.use a water resistant sunscreen if swimming or sweating.Sun Protection Measures: Spending time in the sun increases 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 of age: Ask a doctor.

Inactive Ingredients

1,2-Hexanediol, Acrylates/Dimethicone Copolymer, Allantoin, Alumina, Bis-Vinyl Dimethicone/Dimethicone Copolymer, Bisabolol, Butyloctyl Salicylate, Camellia Oleifera Leaf Extract, Capparis Spinosa Fruit Extract, Caprylic/Capric Triglyceride, Caprylyl Glycol, Cerium Oxide, Cetyl Dimethicone, Dimethicone, Disteardimonium Hectorite, Glycerin, Himanthalia Elongata Extract, Niacinamide, Olea Europaea (Olive) Fruit Extract, Olea Europaea (Olive) Leaf Extract, Opuntia Ficus-Indica Stem Extract, Panthenol, Phenethyl Alcohol, Phenoxyethanol, Phenyl Trimethicone, Plankton Extract, Polyglyceryl-3 Sorbityl Linseedate, Polyglyceryl-4 Oleate, Polygonum Aviculare Extract, Polyhydroxystearic Acid, Polymethyl Methacrylate, Potassium Sorbate, Silica, Sodium Benzoate, Sodium Chloride, Squalane, Stearic Acid, Styrene/Acrylates Copolymer, Synthetic Fluorphlogopite, Tocopheryl Acetate, Triethyl Citrate, Tropolone, Ubiquinone, Water, Zea Mays (Corn) Starch, Zingiber Officinale (Ginger) Root Extract.

Other Information

Protect this product from excessive heat and direct sun.

* Please review the disclaimer below.