Otc - Active Ingredient
Medicinal Ingredients
Zinc Oxide 8.6%
Titanium Dioxide 6.5%
Cloak Spf 50
FDA Label NDC 82038-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Derma Research Group Inc. for the product Cloak Spf 50 (NDC 82038-001). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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).
Package Label.Principal Display Panel
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 (Imgcloakspf50)
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