NDC 73434-002 The Starter Kit

Avobenzone, Homosalate, Octisalate, And Octocrylene

NDC Product Code 73434-002

NDC 73434-002-01

Package Description: 1 KIT in 1 BOX * 30 mL in 1 TUBE * 30 mL in 1 TUBE * 1 UNITS in 1 CASE * 30 mL in 1 TUBE (73434-001-30)

NDC Product Information

The Starter Kit with NDC 73434-002 is a a human over the counter drug product labeled by Mantl. The generic name of The Starter Kit is avobenzone, homosalate, octisalate, and octocrylene. The product's dosage form is kit and is administered via form.

Labeler Name: Mantl

Dosage Form: Kit - A packaged collection of related material.

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.

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.

  • ISODODECANE (UNII: A8289P68Y2)
  • DIMETHICONE/BIS-ISOBUTYL PPG-20 CROSSPOLYMER (UNII: O4I3UFO6ZF)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • DICAPRYLYL ETHER (UNII: 77JZM5516Z)
  • BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
  • LINOLEIC ACID (UNII: 9KJL21T0QJ)
  • LINOLENIC ACID (UNII: 0RBV727H71)
  • .ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC)
  • GINGER (UNII: C5529G5JPQ)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • EPILOBIUM ANGUSTIFOLIUM FLOWERING TOP (UNII: 08H094218D)
  • SODIUM METABISULFITE (UNII: 4VON5FNS3C)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Mantl
Labeler Code: 73434
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: 11-01-2020 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: 12-31-2021 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.

The Starter Kit Product Label Images

The Starter Kit 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

Dist. by Mantl, Inc.Tustin, CA 92780

Otc - Purpose

Active IngredientPurposeAvobenzone 3%SunscreenHomosalate 15%SunscreenOctisalate 5%SunscreenOctocrylene 2.8%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

Otc - Do Not Use

Do not use on damaged or broken skin

Otc - When Using

When using this product keep out of eyes. Rinse with water to remove.

Otc - Stop Use

Stop use and ask a doctor if rash occurs

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 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

Isododecane, Dimethicone/Bis-Isobutyl PPG-20 Crosspolymer, Caprylic/Capric Triglyceride, Dicaprylyl Ether, Butyloctyl Salicylate, Epilobium Angustifolium Flower/Leaf/Stem Extract, Zingiber Officinale (Ginger) Root Extract, Tocopherol, Bisabolol, Linoleic Acid, Linolenic Acid, Silica, Water/Aqua/Eau, Sodium Metabisulfite, Phenoxyethanol, Fragrance (Parfum)

Other Information

Protect this product from excessive heat and direct sun.

* Please review the disclaimer below.