Label: CLOAK SPF 50- zinc oxide and titanium dioxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 82038-001-10 - Packager: Derma Research Group Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated September 24, 2021
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
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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). - PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CLOAK SPF 50
zinc oxide and titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82038-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 86 mg in 1 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 65 mg in 1 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:82038-001-10 113 g in 1 BOTTLE; Type 0: Not a Combination Product 09/13/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 09/13/2021 Labeler - Derma Research Group Inc. (200108372)
