FDA.reportPublic FDA data

Cloak SPF 50

Manufacturer
Derma Research Group Inc.
Effective date
2021-09-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:42:31

Label at a glance#

ProductCloak SPF 50
Active ingredientZINC OXIDE, TITANIUM DIOXIDE
Label structure12 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Medicinal Ingredients
Zinc Oxide 8.6%
Titanium Dioxide 6.5%

OTC - PURPOSE SECTION

Purpose:

Sun Protectant

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

Warning:

For External Use Only.

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

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 SECTION

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

IMGCLOAKSPF50IMGCLOAKSPF50

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
82038-001-102023-01-30C16284748780-1f386c64a-34eb-0266-e053-dadaa90a7c1aDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82038-001-10Cloak SPF 50113 g in 1 BOTTLECREAM1131

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82038-001CLOAK SPF 50 (ZINC OXIDE AND TITANIUM DIOXIDE) CREAM [DERMA RESEARCH GROUP INC.]1Legacy NDC, 1 package rows20210927_ccc4ceef-11ef-72d2-e053-2995a90aea69.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 2 · 65 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82038-00182038-001-10

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 2 · 63 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
WATER059QF0KO0RIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
DIMETHICONE92RU3N3Y1OIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
CETEARYL OLIVATE58B69Q84JOIACT
SORBITAN OLIVATEMDL271E3GRIACT
SILICA DIMETHYL SILYLATEEU2PSP0G0WIACT
PENTYLENE GLYCOL50C1307PZGIACT
ASCORBIC ACIDPQ6CK8PD0RIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
CYCLOTETRAPEPTIDE-24 AMINOCYCLOHEXANE CARBOXYLATENR327745KQIACT
SODIUM CHLORIDE451W47IQ8XIACT
DIPROPYLENE GLYCOLE107L85C40IACT
SODIUM CITRATE1Q73Q2JULRIACT
DIMETHICONE/PEG-10/15 CROSSPOLYMER21AS8B1BSSIACT
CYCLOMETHICONE 4CZ227117JEIACT
POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S)RLA2U05Z4QIACT
STEARIC ACID4ELV7Z65APIACT
SODIUM BENZOATEOJ245FE5EUIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
ALCOHOL3K9958V90MIACT
POLYSORBATE 207T1F30V5YHIACT
PALMITOYL TETRAPEPTIDE-7Q41S464P1RIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
ARABICA COFFEE BEAN3SW678MX72IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
ISOMALTS870P55O2WIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
PHENOXYETHANOLHIE492ZZ3TIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
FERROSOFERRIC OXIDEXM0M87F357IACT
POLYGONUM AVICULARE TOPZCD6009IUFIACT
PALMITOYL TRIPEPTIDE-1RV743D216MIACT
HEXYLENE GLYCOLKEH0A3F75JIACT
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2)V2W71V8T0XIACT
POLYGLYCERYL-4 ISOSTEARATE820DPX33S7IACT
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE)255PIF62MSIACT
BUTYLENE GLYCOL3XUS85K0RAIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ccc4ce6f-b027-4bc2-e053-2a95a90aa51dccc4ceef-11ef-72d2-e053-2995a90aea692021-09-24WarningsExact identifier
spl id: ccc4ce6f-b027-4bc2-e053-2a95a90aa51d
spl set id: ccc4ceef-11ef-72d2-e053-2995a90aea69

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.