NDC 74884-259 Spf 55

Homosalate, Octisalate, Octocrylene, And Titanium Dioxide

NDC Product Code 74884-259

NDC CODE: 74884-259

Proprietary Name: Spf 55 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: Homosalate, Octisalate, Octocrylene, And 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.

Product Characteristics

Shape: RECTANGLE (C48347)

NDC Code Structure

NDC 74884-259-06

Package Description: 30 g in 1 TUBE

NDC Product Information

Spf 55 with NDC 74884-259 is a a human over the counter drug product labeled by As Beauty. The generic name of Spf 55 is homosalate, octisalate, octocrylene, and titanium dioxide. The product's dosage form is cream and is administered via topical form.

Labeler Name: As Beauty

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

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.

Spf 55 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.

  • OCTOCRYLENE 4 g/100g
  • TITANIUM DIOXIDE 4 g/100g
  • HOMOSALATE 10 g/100g
  • OCTISALATE 5 g/100g

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.

  • POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
  • ISOSTEARIC ACID (UNII: X33R8U0062)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • STYRENE (UNII: 44LJ2U959V)
  • ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
  • DIMETHICONE 100 (UNII: RO266O364U)
  • 1,3-BUTADIENE (UNII: JSD5FGP5VD)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • HYDROGENATED COCO-GLYCERIDES (UNII: XDD37N2GPR)
  • ALTEROMONAS MACLEODII (UNII: BPX036043D)
  • NIACINAMIDE (UNII: 25X51I8RD4)
  • ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
  • DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
  • TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
  • SUNFLOWER OIL (UNII: 3W1JG795YI)
  • ROSEMARY (UNII: IJ67X351P9)
  • PROPYLENE CARBONATE (UNII: 8D08K3S51E)
  • WATER (UNII: 059QF0KO0R)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • OCTYLDODECANOL (UNII: 461N1O614Y)
  • POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)
  • ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)
  • GRAPE SEED OIL (UNII: 930MLC8XGG)
  • PANTHENOL (UNII: WV9CM0O67Z)
  • PROPANEDIOL (UNII: 5965N8W85T)
  • STEARALKONIUM HECTORITE (UNII: OLX698AH5P)
  • CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
  • LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)
  • ETHYLHEXYL PALMITATE (UNII: 2865993309)
  • POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
  • CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • CUCUMBER (UNII: YY7C30VXJT)
  • BROWN IRON OXIDE (UNII: 1N032N7MFO)
  • XYLOSE (UNII: A1TA934AKO)
  • PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)
  • 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: As Beauty
Labeler Code: 74884
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: 05-15-2021 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Spf 55 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

Dosage & Administration

Apply liberally 15 minutes before sun exposure. Reapply at least every 2 hours. Use a Water Resistant Sunscreen if Swimming or Sweating.Children under 6 years of age should be supervised when usingSun 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 value of 15 or higher, and other sun protection measures including: Limit Time in the sun especially from 10 am to 2 pm. Wear long sleeved shirts, pants, hats and sunglasses.

Inactive Ingredient

Water (Aqua), Butylene Glycol, Polymethyl Methacrylate, Cyclopentasiloxane, Octyldodecanol, Octyldodecyl Xyloside, PEG-30 Dipolyhydroxystearate, Isononyl Isononanoate, Propanediol, Caprylic/Capric Triglyceride, Stearalkonium Hectorite, Propylene Carbonate, Cetyl PEG/PPG-10/1 Dimethicone, Lecithin, Polyhydroxystearic Acid, Ethylhexyl Palmitate, Isopropyl Myristate, Isostearic Acid, Polyglyceryl-3 Polyricinoleate, Dimethicone/Vinyl Dimethicone Crosspolymer, Silica, Dimethicone, Sodium Chloride, Triethoxycaprylylsilane, Styrene/butadiene copolymer, Phenoxyethanol, Caprylyl Glycol, Hydrogenated Coco-Glycerides, Alteromonas Ferment Extract, Helianthus Annuus (Sunflower) Seed Oil, Rosa Canina Fruit Oil, Tocopherol, Rosmarinus Officinalis (Rosemary) Extract, Vitis Vinifera (Grape) Seed Oil, Panthenol, Niacinamide, Cucumis Sativus (Cucumber) Fruit Extract. May Contain: Iron Oxides

Indications & Usage

When Using this product keep out of eyes, ears and mouth. In case of contact with eyes, rinse thoroughly with water.Stop Use and ask a dotor if irritation or rash occurs. These may be signs of a serious condition

Otc - Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN

Otc - Purpose

Sunscreen

Warnings

For External Use Only.Do Not Use On Damaged or Broken SkinWhen Using this product keep out of eyes, ears and mouth. In case of contact with eyes, rinse thoroughly with water.Stop Use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

* Please review the disclaimer below.