CLOAK SPF 50- zinc oxide and titanium dioxide cream 
Derma Research Group Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Medicinal Ingredients
Zinc Oxide 8.6%
Titanium Dioxide 6.5%

Purpose:

Sun Protectant

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

Warning:

For External Use Only.

Do not use on damaged or broken skin

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

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

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

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

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

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).

Imp. by Derma Research Group Canada. Made in the USA of US and/or Imported
Ingredients Questions? 1-855-968-3600.
www.dermaresearch.com

IMGCLOAKSPF50

CLOAK SPF 50 
zinc oxide and titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82038-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE86 mg  in 1 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE65 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82038-001-10113 g in 1 BOTTLE; Type 0: Not a Combination Product09/13/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35209/13/2021
Labeler - Derma Research Group Inc. (200108372)

Revised: 9/2021
Document Id: ccc4ce6f-b027-4bc2-e053-2a95a90aa51d
Set id: ccc4ceef-11ef-72d2-e053-2995a90aea69
Version: 1
Effective Time: 20210924
 
Derma Research Group Inc.