FDA.reportPublic FDA data

Suntone After Sun Burn Relief Gel with Lidocaine

Manufacturer
Prime Enterprises Inc.
Effective date
2020-06-08
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:16:26

Label at a glance#

ProductSuntone After Sun Burn Relief Gel with Lidocaine
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure8 sections

Indications and uses

For the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites or minor skin irritations.

Dosage and administration

Adults and children 2 years of age and older, apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: Ask a doctor

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Lidocaine Hydrochloride (0.72%)

Purpose

OTC - PURPOSE SECTION

External Analgesic

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites or minor skin irritations.

WARNINGS SECTION

For external use only.

SPL UNCLASSIFIED SECTION

Avoid contact with the eyes.

SPL UNCLASSIFIED SECTION

If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and contact a physician.

OTC - DO NOT USE SECTION

Do not use in large quantities, particularly over raw surfaces or blistered areas.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 2 years of age and older, apply to affected area not more than 3 to 4 times daily.
  • Children under 2 years of age: Ask a doctor

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Juice, Benzophenone-4, Blue 1, Carbomer, Diazolidinyl Urea, Disodium EDTA, DMDM Hydantoin, Fragrance, Menthol, Methylparaben, Polysorbate 20, Propylene Glycol, SD Alcohol 40-B, Triethanolamine, Water, Yellow 5

Questions or Comments?

OTC - QUESTIONS SECTION

Biocycle Laboratories, Inc.

16363 NW 49 Avenue, Miami, FL 33014

Suntone After Sun Burn Relief with Lidocaine

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display ImagePrincipal Display Image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1723988lidocaine HCl 0.72 % Topical GelPSN3
1723988lidocaine hydrochloride 0.0072 MG/MG Topical GelSCD3
1723988lidocaine hydrochloride 0.72 % Topical GelSY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LIDOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58443-0125-62023-01-30C16284748780-1f386c649-b1fb-0266-e053-dadaa90a7c1aSuntone After Sun Burn Relief Gel with Lidocaine

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58443-0125-6SuntoneAfter Sun Burn Relief Gel with Lidocaine470 mL in 1 BOTTLEGEL4703

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58443-0125SUNTONE AFTER SUN BURN RELIEF GEL WITH LIDOCAINE (LIDOCAINE HYDROCHLORIDE) GEL [PRIME ENTERPRISES INC.]3Legacy NDC, 1 package rows20200609_2bea8016-ad69-661d-e054-00144ff88e88.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58443-012558443-0125-6

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
SULISOBENZONE1W6L629B4KIACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
EDETATE DISODIUM7FLD91C86KIACT
MENTHOLL7T10EIP3AIACT
METHYLPARABENA2I8C7HI9TIACT
TROLAMINE9O3K93S3TKIACT
CARBOMER 9404Q93RCW27EIACT
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT
POLYSORBATE 207T1F30V5YHIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
DMDM HYDANTOINBYR0546TOWIACT
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR

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
a7945b56-5d0f-2ea7-e053-2995a90a6b082bea8016-ad69-661d-e054-00144ff88e882020-06-08WarningsExact identifier
spl id: a7945b56-5d0f-2ea7-e053-2995a90a6b08
spl set id: 2bea8016-ad69-661d-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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