NDC 72284-0004 Im Pure Cica Sunscreen

Zinc Oxide, Titanium Dioxide

NDC Product Code 72284-0004

NDC 72284-0004-1

Package Description: 1 TUBE in 1 BOX > 50 mL in 1 TUBE

NDC Product Information

Im Pure Cica Sunscreen with NDC 72284-0004 is a a human over the counter drug product labeled by Normalest Co., Ltd.. The generic name of Im Pure Cica Sunscreen is zinc oxide, titanium dioxide. The product's dosage form is lotion and is administered via topical form.

Labeler Name: Normalest Co., Ltd.

Dosage Form: Lotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2

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.


Im Pure Cica Sunscreen 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.

  • ZINC OXIDE 5.82 g/50mL
  • TITANIUM DIOXIDE 1.56 g/50mL

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.

  • 1,2-HEXANEDIOL (UNII: TR046Y3K1G)
  • SUNFLOWER SEED OIL GLYCERETH-8 ESTERS (UNII: 358X17CAT0)
  • CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9)
  • CARDIOSPERMUM HALICACABUM WHOLE (UNII: 185RQ97K0V)
  • MADECASSOSIDE (UNII: CQ2F5O6YIY)
  • HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
  • CENTELLA ASIATICA LEAF (UNII: 6810070TYD)
  • INVERT SUGAR (UNII: ED959S6ACY)
  • CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
  • MAGNESIUM SULFATE ANHYDROUS (UNII: ML30MJ2U7I)
  • POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
  • OCTYLDODECANOL (UNII: 461N1O614Y)
  • ECHIUM PLANTAGINEUM SEED OIL (UNII: PIB7XBU8XW)
  • WATER (UNII: 059QF0KO0R)
  • CYCLOMETHICONE (UNII: NMQ347994Z)
  • ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
  • DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
  • PROPANEDIOL (UNII: 5965N8W85T)
  • POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: RLA2U05Z4Q)
  • DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
  • SALVIA HISPANICA SEED (UNII: NU0OLX06F8)
  • HOUTTUYNIA CORDATA WHOLE (UNII: O3E12ZLW5T)
  • PULLULAN (UNII: 8ZQ0AYU1TT)
  • DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • PENTYLENE GLYCOL (UNII: 50C1307PZG)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • FOSFRUCTOSE (UNII: M7522JYX1H)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

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: Normalest Co., Ltd.
Labeler Code: 72284
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: 03-06-2019 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: 12-31-2020 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.

Im Pure Cica Sunscreen Product Label Images

Im Pure Cica Sunscreen 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

Active Ingredients
Zinc Oxide (11.6%)

Titanium Dioxide (3.1%)

Inactive Ingredient

Inactive IngredientsWater, Cyclomethicone, Hydrogen Dimethicone, Aluminum Hydroxide, Stearic Acid, Dicaprylyl Carbonate, Propanediol, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Dimethicone Crosspolymer, Phenyl Trimethicone, Salvia Hispanica Seed Extract, Centella Asiatica Extract, Houttuynia Cordata Extract, 1,2-Hexanediol, Saccharide Hydrolysate, Fructooligosaccharides, Pullulan, Cetyl Ethylhexanoate, Disteardimonium Hectorite, Magnesium Sulfate, Polyglyceryl-2 Dipolyhydroxystearate, Helianthus Annuus (Sunflower) Seed Oil, Anthemis Nobilis Flower Oil, Ethylhexylglycerin, Octyldodecanol, Echium Plantagineum Seed Oil, Cardiospermum Halicacabum Flower/Leaf/Vine Extract, Helianthus Annuus (Sunflower) Seed Oil Unsaponifiables, Tocopherol, Galactomyces Ferment Filtrate, Butylene Glycol, Pentylene Glycol, Caprylyl Glycol, Madecassoside

* Please review the disclaimer below.

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