NDC 82235-304 The Pure Lotus Jeju Botanical Suncream

Homosalate, Octocrylene

NDC Product Code 82235-304

NDC 82235-304-01

Package Description: 50 mL in 1 TUBE

NDC Product Information

The Pure Lotus Jeju Botanical Suncream with NDC 82235-304 is a a human over the counter drug product labeled by The Lotus Co.,ltd.. The generic name of The Pure Lotus Jeju Botanical Suncream is homosalate, octocrylene. The product's dosage form is cream and is administered via topical form.

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.

The Pure Lotus Jeju Botanical Suncream 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.


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.

  • VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)
  • LIMONENE, (+)- (UNII: GFD7C86Q1W)
  • LEMON OIL (UNII: I9GRO824LL)
  • ROSEMARY OIL (UNII: 8LGU7VM393)
  • CITRAL (UNII: T7EU0O9VPP)
  • LIME OIL (UNII: UZH29XGA8G)
  • CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • ADENOSINE (UNII: K72T3FS567)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • NELUMBO NUCIFERA LEAF (UNII: 60C608DPVT)
  • RICE GERM (UNII: 7N2B70SFEZ)
  • ROSEMARY (UNII: IJ67X351P9)
  • 1,2-HEXANEDIOL (UNII: TR046Y3K1G)
  • OPUNTIA COCHENILLIFERA FRUIT (UNII: 838ZTK02KH)
  • BEMOTRIZINOL (UNII: PWZ1720CBH)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • NIACINAMIDE (UNII: 25X51I8RD4)
  • PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)
  • EUCALYPTUS OIL (UNII: 2R04ONI662)
  • MALLOTUS JAPONICUS BARK (UNII: 4PG720HL9T)
  • TANGERINE PEEL (UNII: JU3D414057)
  • WATER (UNII: 059QF0KO0R)
  • GREEN TEA LEAF (UNII: W2ZU1RY8B0)
  • NELUMBO NUCIFERA ROOT (UNII: F60P1G6K6N)
  • ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • TROMETHAMINE (UNII: 023C2WHX2V)
  • CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
  • SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
  • ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • C14-22 ALCOHOLS (UNII: B1K89384RJ)
  • C12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA)
  • ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK)
  • DOCOSANOL (UNII: 9G1OE216XY)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • LINALOOL, (+/-)- (UNII: D81QY6I88E)
  • LAVENDER OIL (UNII: ZBP1YXW0H8)
  • JUNIPERUS DEPPEANA WOOD OIL (UNII: 4739QA5686)
  • CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9)
  • SORBITAN OLIVATE (UNII: MDL271E3GR)
  • CETEARYL OLIVATE (UNII: 58B69Q84JO)

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: The Lotus Co.,ltd.
Labeler Code: 82235
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: 09-15-2021 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.

The Pure Lotus Jeju Botanical Suncream Product Label Images

The Pure Lotus Jeju Botanical Suncream 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

Active Ingredients

Homosalaste(10%)Octocrylene(3%)

Purpose

Sunscreen

Uses

  • Helps prevent sunburn and decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

For external use only

Stop Use And Ask Doctor If

  • Condition worsenssymptoms last more than 7days or clear up and occur again within a few days

Do Not Use

  • Do not apply to wounds or damaged skinIn case of abnormal symptoms or side effects of red spots, swelling, or itchingDo not get into eyes.

Keep Out Of Reach Of Children.

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

Direction

  • For Sunscreen use;Apply to your skin evenly and put on 3~4times per day

Other Information

  • Store at room temperature away from direct sunlight.

Inactive Ingredients

Water, Aloe Barbadensis Leaf Extract, Camellia Sinensis Leaf Extract, Butylene Glycol, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Niacinamide, 1,2-Hexanediol, Nelumbo Nucifera Leaf Extract, Glyceryl Stearate, C14-22 Alcohols, Oryza Sativa (Rice) Extract, Cetearyl Olivate, Arachidyl Alcohol, Citrus Unshiu Peel Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Nelumbo Nucifera Root Extract, Tromethamine, VP/Eicosene Copolymer, Sorbitan Olivate, Opuntia Coccinellifera Fruit Extract, Behenyl Alcohol, Sodium Stearoyl Glutamate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Ethylhexylglycerin, Caprylyl Glycol, Citrus Limon (Lemon) Peel Oil, C12-20 Alkyl Glucoside, Carbomer, Arachidyl Glucoside, Mallotus Japonicus Bark Extract, Xanthan Gum, Adenosine, Lavandula Angustifolia (Lavender) Oil, Rosmarinus Officinalis (Rosemary) Leaf Oil, Glucose, Citrus Aurantifolia (Lime) Oil, Juniperus Mexicana Oil, Pelargonium Graveolens Flower Oil, Eucalyptus Globulus Leaf Oil, Chamomilla Recutita (Matricaria) Flower Oil, Limonene, Linalool, Citral.

* Please review the disclaimer below.