FDA.reportPublic FDA data

Prequel Skin Utility Balm Multi-Purpose Skin Protectant

Manufacturer
The Center Brands, LLC
Effective date
2025-12-04
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:19:51

Label at a glance#

ProductPrequel Skin Utility Balm Multi-Purpose Skin Protectant
Active ingredientDIMETHICONE
Label structure10 sections

Indications and uses

Temporarily protects and helps releive chafed, chapper or cracked skin Helps protect fomr the drying effects of wind and cold weather

Dosage and administration

Apply as needed.

Label contents#

Full prescribing information#

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Dimethicone 5.25%

Uses

INDICATIONS & USAGE SECTION

Temporarily protects and helps releive chafed, chapper or cracked skin

Helps protect fomr the drying effects of wind and cold weather

Warnings

WARNINGS SECTION

Fox external use only.

When using this product do not get into eyes

Stop use and ask a doctor if condition worsens

symptoms last more than 7 days or clear up and occur again within a few days

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Apply as needed.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), Propanediol, Cetearyl Alcohol, Butyrospermum Parkii (Shea) Butter, Undecane, Glycerin, Dipentaerythryityl Hexahydrostearate/Hexastearate/Hexarosinate, Isosorbate Dicaprylate, Cetearyl Olivate, Tridecane, Sorbitan Olivate, Silica, Ceramide NP, Cholesterol, Phytospingosine, Hydrogentaed Lecithin, Centella Asiatica Extract, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Ammonium Acryloyldimethyltuarate/VP Copolymer, Hydrogenated Polydecene, Xanthan Gum, Stearic Acid, Sodium Phytate, Tocopheryl Acetate, Camomilla Recutita Flower Extract, Aloe Barbadensis Leaf Juice, Phenoxyethanol, Ethylhexylglycerin, Citric Acid, Caprylic/Capric Trigylceride, Lactic Acid, Oleic Acid, Laureth-8, Caprylyl Glycol, Caprylhydroxamic Acid, Tocopherol, Potassium Sorbate, Sodium Benzoate, Sodium Sulfate, t-Butyl Acohol

Other Information

SPL UNCLASSIFIED SECTION

• Store in controlled temperatures (4-20°C/39-68°F). Keep in a dark and dry place.

Questions?

OTC - QUESTIONS SECTION

Visit prequelskin.com

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

82800-06082800-060

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIMETHICONE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82800-060-01Prequel Skin Utility Balm Multi-Purpose Skin Protectant1 in 1 PACKAGEOINTMENT14
82800-060-01Prequel Skin Utility Balm Multi-Purpose Skin Protectant50 g in 1 TUBEOINTMENT504

Products#

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

DailyMed product names page 1 of 1 · 39 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82800-06082800-060-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 37 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
PROPANEDIOL5965N8W85TIACT
BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES0C9AC7D6XUIACT
UNDECANEJV0QT00NUEIACT
DIPENTAERYTHRITYL HEXASTEARATEWTF09990PKIACT
GLYCERINPDC6A3C0OXIACT
ISOSORBIDE DICAPRYLATE0IK29C4889IACT
CETEARYL OLIVATE58B69Q84JOIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
PHENOXYETHANOLHIE492ZZ3TIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
CERAMIDE NP4370DF050BIACT
CHOLESTEROL97C5T2UQ7JIACT
PHYTOSPHINGOSINEGIN46U9Q2QIACT
HYDROGENATED SOYBEAN LECITHINH1109Z9J4NIACT
CENTELLA ASIATICA7M867G6T1UIACT
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW)1DXE3F3OZXIACT
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMERW59H9296ZGIACT
HYDROGENATED POLYDECENE TYPE IU333RI6EB7IACT
XANTHAN GUMTTV12P4NEEIACT
STEARIC ACID4ELV7Z65APIACT
HEXASODIUM PHYTATEZBX50UG81VIACT
CAMELLIA OLEIFERA LEAF5077EL0C60IACT
CHAMOMILE FLOWER OIL60F80Z61A9IACT
ALOE VERA LEAFZY81Z83H0XIACT
CITRIC ACID ACETATEDSO12WL7AUIACT
LACTIC ACID33X04XA5ATIACT
OLEIC ACID2UMI9U37CPIACT
LAURETH-8QU7U88D04IIACT
CAPRYLYL GLYCOL00YIU5438UIACT
CAPRYLHYDROXAMIC ACIDUPY805K99WIACT
TOCOPHEROLR0ZB2556P8IACT
POTASSIUM SORBATE1VPU26JZZ4IACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM SULFATE0YPR65R21JIACT
TERT-BUTYL ACETATE76N22HKP3XIACT
DIMETHICONE92RU3N3Y1OACTIB

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
Prequel Skin Utility Balm Multi-Purpose Skin ProtectantSKIN PROTECTANT BALMThe Center Brands, LLC57c0b71d-6099-415c-976d-b96d2f73e9d32025-12-04WarningsExact identifier
ndc (package): 82800-060-01
ndc (product): 82800-060
ndc11 (package): 82800006001
spl id: 45200b9a-09cd-e40d-e063-6394a90a09f4
spl set id: 57c0b71d-6099-415c-976d-b96d2f73e9d3

Reported adverse events (FAERS/openFDA)#

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