NDC 70618-009 Thank You Farmer Safe Sun Fluid Age 0880

Titanium Dioxide

NDC Product Code 70618-009

NDC 70618-009-02

Package Description: 1 CONTAINER in 1 CARTON > 100 mL in 1 CONTAINER (70618-009-01)

NDC Product Information

Thank You Farmer Safe Sun Fluid Age 0880 with NDC 70618-009 is a a human over the counter drug product labeled by Thank You Farmer Co., Ltd.. The generic name of Thank You Farmer Safe Sun Fluid Age 0880 is titanium dioxide. The product's dosage form is cream and is administered via topical form.

Labeler Name: Thank You Farmer Co., Ltd.

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.

Thank You Farmer Safe Sun Fluid Age 0880 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 7.99 mg/100mL

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.

  • WATER (UNII: 059QF0KO0R)
  • ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • DIPROPYLENE GLYCOL (UNII: E107L85C40)
  • NIACINAMIDE (UNII: 25X51I8RD4)
  • BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
  • CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
  • 1,2-HEXANEDIOL (UNII: TR046Y3K1G)
  • ALUMINUM STEARATE (UNII: U6XF9NP8HM)
  • POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
  • CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • PENTYLENE GLYCOL (UNII: 50C1307PZG)
  • POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • ALUMINUM OXIDE (UNII: LMI26O6933)
  • PROPANEDIOL (UNII: 5965N8W85T)
  • AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
  • AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)
  • INVERT SUGAR (UNII: ED959S6ACY)
  • SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
  • OCTYLDODECANOL (UNII: 461N1O614Y)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • ADENOSINE (UNII: K72T3FS567)

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: Thank You Farmer Co., Ltd.
Labeler Code: 70618
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: 02-10-2020 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.

Thank You Farmer Safe Sun Fluid Age 0880 Product Label Images

Thank You Farmer Safe Sun Fluid Age 0880 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

Otc - Active Ingredient

Titanium Dioxide 7.99% ..………………..……Sunscreen

Otc - Purpose

Sunscreen

Indications & Usage

Helps prevent sunburn

Dosage & Administration

Apply liberally 15 minutes before sun exposure. Reapply at least every two hoursSun 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 of 15 of higher and other sun protection measures including: 1) Limited time in the sun, especially from 10 am to 2 pm. 2) Wear long-sleeve shirts, pants, hats, and sunglasses


Ask a doctor to use for children under 6 months

Warnings

For external use onlyDo not use on damaged or broken skinStop using and ask a doctor if rash occursWhen using this product, keep out of eyes. Rinse with water to remove

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away

Inactive Ingredient

WATER, C12-15 ALKYL BENZOATE, BUTYLENE GLYCOL, DIPROPYLENE GLYCOL, NIACINAMIDE, BUTYLOCTYL SALICYLATE, CAPRYLYL METHICONE, 1,2-HEXANEDIOL, ALUMINUM STEARATE, POLYHYDROXYSTEARIC ACID, CETYL ETHYLHEXANOATE, SILICA, PENTYLENE GLYCOL, POLYMETHYLSILSESQUIOXANE, CAPRYLIC/CAPRIC TRIGLYCERIDE, ALUMINA, PROPANEDIOL, AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER, FRAGRANCE, POLYACRYLATE CROSSPOLYMER-6, SACCHARIDE HYDROLYSATE, SODIUM STEAROYL GLUTAMATE, HYDROXYPROPYL METHYLCELLULOSE STEAROXY ETHER, OCTYLDODECANOL, STEARIC ACID, ETHYLHEXYLGLYCERIN, ADENOSINE, SALVIA HISPANICA SEED EXTRACT, CENTELLA ASIATICA EXTRACT, PORTULACA OLERACEA EXTRACT, HOUTTUYNIA CORDATA EXTRACT, ECHIUM PLANTAGINEUM SEED OIL, CURCUMA LONGA (TURMERIC) ROOT EXTRACT, T-BUTYL ALCOHOL, CARDIOSPERMUM HALICACABUM FLOWER/LEAF/VINE EXTRACT, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL UNSAPONIFIABLES, GLYCERIN, TOCOPHEROL, CAMELLIA JAPONICA FLOWER EXTRACT, CHAMOMILLA RECUTITA (MATRICARIA) FLOWER/LEAF EXTRACT, PANCRATIUM MARITIMUM EXTRACT

* Please review the disclaimer below.