NDC 59189-101 Radiance Cc Spf 30

Zinc Oxide

NDC Product Code 59189-101

NDC Product Information

Radiance Cc Spf 30 with NDC 59189-101 is a a human over the counter drug product labeled by Dr. J Skinclinic, Inc.. The generic name of Radiance Cc Spf 30 is zinc oxide. The product's dosage form is cream and is administered via topical form.

Labeler Name: Dr. J Skinclinic, Inc.

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.


Radiance Cc Spf 30 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 13 g/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.

  • ALOE VERA WHOLE (UNII: KIZ4X2EHYX)
  • RUBUS URSINUS WHOLE (UNII: EB3AN7DKSL)
  • KIWI FRUIT (UNII: 71ES77LGJC)
  • POMEGRANATE JUICE (UNII: 99S671U9KB)
  • GRAPE (UNII: 6X543N684K)
  • JOJOBA OIL (UNII: 724GKU717M)
  • ARGAN OIL (UNII: 4V59G5UW9X)
  • BORAGE OIL (UNII: F8XAG1755S)
  • CRANBERRY SEED OIL (UNII: 73KDS3BW5E)
  • ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)
  • RUBUS IDAEUS SEED (UNII: M3CL7US2ZG)
  • SAFFLOWER OIL (UNII: 65UEH262IS)
  • COCONUT OIL (UNII: Q9L0O73W7L)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • FERROUS OXIDE (UNII: G7036X8B5H)
  • STARCH, TAPIOCA (UNII: 24SC3U704I)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • BENZYL ALCOHOL (UNII: LKG8494WBH)
  • GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
  • GLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • LIMONENE, (+)- (UNII: GFD7C86Q1W)
  • LINALOOL, (+)- (UNII: F4VNO44C09)

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: Dr. J Skinclinic, Inc.
Labeler Code: 59189
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: 02-02-2019 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.

Radiance Cc Spf 30 Product Label Images

Radiance Cc Spf 30 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 Ingredient

Non-Nano UncoatedZinc Oxide (13%)

Purpose

SUNSCREEN

Uses

HELPS PREVENT SUNBURN.

Warnings:

For External Use Only.Do not use on damaged or broken skin.When using this product keep out of eyes. Rinse with water to remove.Stop use and ask a doctor if rash or irritation occurs.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children:If swallowed, get medical help or contact Poison Control Center immediately.

Directions:

Shake well for several seconds, then apply liberally over the face and neck 15 minutes prior to sun exposure.

Inactive Ingredients:

*(Decolorized) Aloe Barbadensis (Aloe Vera) Leaf Juice, *Rubus Ursinus (California Blackberry) Fruit, *Actinidia Chinensis (California Kiwi) Fruit, *Punica Granatum (California Pomegranate) Fruit, *Vitis Vinifera (California Grapes) Fruit, *Simmondsia Chinensis (Jojoba) Seed Oil, *Argania Spinosa (Argan) Kernel Oil, *Borago Officinalis (Borage) Seed Oil, *Vaccinium Macrocarpon (Cranberry) Seed Oil, *Rosa Canina (Rosehip) Fruit Oil, Tocopherol, *Rubus Idaeus (Raspberry) Seed Oil, *Carthamus Tinctorius (Safflower) Seed Oil, *Cocos Nucifera (Coconut) Oil, Glycerin, CI 77492,CI 77491, CI 77499, CI 77891, *Tapioca Starch, Silica, Benzyl Alcohol,Glyceryl Caprylate, Glyceryl Undecylenate, Sodium Benzoate, Potassium Sorbate, Limonene, Linalool, Fragrance (Natural Parfum) *organicDermatology tested.

* Please review the disclaimer below.

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