NDC 62217-301 Fruit Of The Earth Sun Town City

Spf 30 Continuous Spray Sunscreen

NDC Product Code 62217-301

NDC 62217-301-74

Package Description: 76.5 g in 1 CAN

NDC Product Information

Fruit Of The Earth Sun Town City with NDC 62217-301 is a a human over the counter drug product labeled by Fruit Of The Earth, Inc.. The generic name of Fruit Of The Earth Sun Town City is spf 30 continuous spray sunscreen. The product's dosage form is aerosol, spray and is administered via topical form.

Labeler Name: Fruit Of The Earth, Inc.

Dosage Form: Aerosol, Spray - An aerosol product which utilizes a compressed gas as the propellant to provide the force necessary to expel the product as a wet spray; it is applicable to solutions of medicinal agents in aqueous solvents.

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.

Fruit Of The Earth Sun Town City 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.

  • AVOBENZONE 20 mg/g
  • HOMOSALATE 70 mg/g
  • OCTOCRYLENE 50 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.

  • ALCOHOL (UNII: 3K9958V90M)
  • ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK)
  • ISODODECANE (UNII: A8289P68Y2)
  • DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)
  • PEG-12 DIMETHICONE (UNII: ZEL54N6W95)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • HYDROGENATED METHYL ABIETATE (UNII: A23O709X8O)
  • MINERAL OIL (UNII: T5L8T28FGP)
  • PANTHENOL (UNII: WV9CM0O67Z)
  • WATER (UNII: 059QF0KO0R)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)

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.
  • 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: Fruit Of The Earth, Inc.
Labeler Code: 62217
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: 02-05-2020 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.

Fruit Of The Earth Sun Town City Product Label Images

Fruit Of The Earth Sun Town City 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

Warnings And Precautions

Avobenzone 2.0%, Homosalate 7.0%, Octocrylene 5.0%

Purpose

Sunscreen

Uses

• helps prevent sunburn • if used as directed with other sun protectino measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

For external use only

Flammable:

  • Do not use near heat, flame or while smokingavoid long term storage above 104°F (40°C)

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 • keep away from face to avoid breathing it. • do not puncture or incerate. Contents under pressures. • do not store at temperatures above 120°F.

Otc - Ask Doctor

Stop use and ask a doctor if • if rash occurs.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Spray liberally and spread evenly by hand 15 minutes before sun exposureHold can 4-6 inches away from the skin to applyDo not spray directly into face. Spray into hands then apply to faceDo not apply in windy conditionsUse in a well-ventilated area.Reapply:     • after 80 minutes of swimming or sweating    • immediately after towel drying    • at least every 2 hoursChildren under 6 months of age: Ask a doctorSun 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 othe rsun protection measures including:    • limit time in the sun, especially from 10 a.m. - 2 p.m.    • wear long-sleeve shirts, pants, hats, and sunglasses

Other Information

  • Protect the product in this container from excessive heat and direct sunmay stain or damage some fabrics, materials or surfaces

Inactive Ingredients

Alcohol denat., isododecane, diisopropyl adipate, acrylates/octylacrylamide copolymer, VA/butyl maleate/isobornyl acrylate copolymer, PEG-12 dimethicone, caprylyl glycol, hydrogenated methyl abietate, tocopheryl acetate, mineral oil, panthenol, water, aloe barbadensis leaf extract, fragrance.

* Please review the disclaimer below.