NDC 82038-001 Cloak Spf 50

Zinc Oxide And Titanium Dioxide

NDC Product Code 82038-001

NDC 82038-001-10

Package Description: 113 g in 1 BOTTLE

NDC Product Information

Cloak Spf 50 with NDC 82038-001 is a a human over the counter drug product labeled by Derma Research Group Inc.. The generic name of Cloak Spf 50 is zinc oxide and titanium dioxide. 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.

Cloak Spf 50 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.

  • ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
  • DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
  • WATER (UNII: 059QF0KO0R)
  • ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • CETEARYL OLIVATE (UNII: 58B69Q84JO)
  • SORBITAN OLIVATE (UNII: MDL271E3GR)
  • SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
  • PENTYLENE GLYCOL (UNII: 50C1307PZG)
  • ASCORBIC ACID (UNII: PQ6CK8PD0R)
  • LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
  • CYCLOTETRAPEPTIDE-24 AMINOCYCLOHEXANE CARBOXYLATE (UNII: NR327745KQ)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • DIPROPYLENE GLYCOL (UNII: E107L85C40)
  • SODIUM CITRATE (UNII: 1Q73Q2JULR)
  • DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)
  • CYCLOMETHICONE 4 (UNII: CZ227117JE)
  • POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: RLA2U05Z4Q)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • ALCOHOL (UNII: 3K9958V90M)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)
  • GREEN TEA LEAF (UNII: W2ZU1RY8B0)
  • ARABICA COFFEE BEAN (UNII: 3SW678MX72)
  • FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
  • ISOMALT (UNII: S870P55O2W)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
  • FERROSOFERRIC OXIDE (UNII: XM0M87F357)
  • POLYGONUM AVICULARE TOP (UNII: ZCD6009IUF)
  • PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)
  • HEXYLENE GLYCOL (UNII: KEH0A3F75J)
  • CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
  • POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
  • PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • HYALURONATE SODIUM (UNII: YSE9PPT4TH)
  • ASCORBYL PALMITATE (UNII: QN83US2B0N)
  • SODIUM FERROCYANIDE DECAHYDRATE (UNII: CG0CLR485X)
  • ECTOINE (UNII: 7GXZ3858RY)
  • CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
  • WINE GRAPE (UNII: 3GOV20705G)
  • BENZOIC ACID (UNII: 8SKN0B0MIM)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • APPLE (UNII: B423VGH5S9)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • ETHYLHEXYL PALMITATE (UNII: 2865993309)
  • CYCLOMETHICONE 6 (UNII: XHK3U310BA)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
  • HEXYL LAURATE (UNII: 4CG9F9W01Q)
  • POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
  • TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE (UNII: X75PL53TZJ)
  • HYDROXYTYROSOL (UNII: QEU0NE4O90)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)

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: Derma Research Group Inc.
Labeler Code: 82038
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 FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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: 09-13-2021 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.

Cloak Spf 50 Product Label Images

Cloak Spf 50 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

Medicinal Ingredients




Zinc Oxide 8.6%




Titanium Dioxide 6.5%

Otc - Purpose

Purpose: Sun Protectant

Indications & Usage

Uses / Indications




Helps prevent sunburn / if used as directed with other sun protection measures (see Directions), decreases the risk of skin caner

Warnings

Warning:For External Use Only.

Otc - Do Not Use

Do not use on damaged or broken skin

Otc - When Using

When using this product – avoid contact with the eyes. If contact occurs, rinse thoroughly with water.

Otc - Stop Use

Discontinue use – if rash or irritation develops or lasts. If irritation persists, consult a doctor.

Otc - Keep Out Of Reach Of Children

Keep out of reach of Children – if swallowed get medical help or contact Poison Control Center right away.

Dosage & Administration

Directions - Apply liberally 15 minutes before sun exposure – Reapply at least every 2 hours.

Other Safety Information

For use on children less than 6 months of age, consult a health care professional.

Inactive Ingredient

Inactive ingredients




Water, Cyclopentasiloxane, C12-15 Alkyl Benzoate, Dimethicone, Cyclotetrasiloxane,




Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Polysilicone-31, Glycerin, Aluminum




Hydroxide, Stearic Acid, Dimethicone/PEG-10/15 Crosspolymer, Pyrus Malus (Apple) Fruit




Extract, Sodium Chloride, Dipropylene Glycol, Sodium Citrate, Tocopherol,




Dimethicone/Polyglycerin-3 Crosspolymer, Dimethicone/ Vinyl Dimethicone Crosspolymer,




Tocopheryl Acetate, PEG/PPG-18/18 Dimethicone, Polyglyceryl-4 Isostearate, Cetyl




PEG/PPG-10/1 Dimethicone, Hexyl Laurate, Pentaerythrityl Tetra-di-t-butyl




Hydroxyhydrocinnamate, Cetearyl Olivate, Sorbitan Olivate, Benzoic Acid, Ethylhexyl




Palmitate, Silica Dimethyl Silylate, Butylene Glycol, Pentylene Glycol, Sodium Hyaluronate,




Cyclohexasiloxane, PEG-8, Ascorbyl Palmitate, Ascorbic Acid, Triethoxysilylethyl




Polydimethylsiloxyethyl Hexyl Dimethicone, Sodium Ferrocyanide Decahydrate,




Hydroxytyrosol, Polygonum Aviculare Extract, Sodium Benzoate, Potassium Sorbate,




Alcohol, Lecithin, Ectoin, Cyclotetrapeptide-24 Aminocyclohexane Carboxylate, Carbomer,




Polysorbate 20, Palmitoyl Tripeptide-1, Palmitoyl Tetrapeptide-7, Vitis Vinifera (Grape) Fruit




Cell Extract, Isomalt, Camellia Sinensis Leaf Extract, Coffea Arabica (Coffee) Seed Extract,




Citric Acid, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol,




Triethoxycaprylylsilane, Iron Oxides (CI 77491, CI 77492, CI 77499).

* Please review the disclaimer below.