FDA.reportPublic FDA data

SunBurnt PLUS

Manufacturer
Quest Products, LLC. | Fill Tech USA
Effective date
2024-02-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:08:56

Key Label Information#

Active Ingredients And Purpose

Active Ingredient

Lidocaine Hydrochloride 4%

Purpose

Topical Pain Relief

Uses

Uses

Temporarily relieves pain and itching due to: sunburn minor burns insect bites minor skin irritations minor cuts scrapes

Warnings

Warnings

For external use only

Directions And Dosage

Directions

clean skin and apply to affected area adults and children 2 years of age and older: apply to affected area not more than 3-4 times daily children under 2 years of age: ask a doctor

Other Label Information

Other Information

store at 15-30°C (59-86°F) do not use if seal under cap is open or missing

Inactive Ingredients

Water, Hydroxyethylcellulose,Glycerin, Phenoxyethanol, Aloe Barbadensis Leaf Juice, D-Panthenol, Calunda Officinalis Extract, Echinacea Purpurea Root Extract, Mannitol, Sodium Hyaluronate, Lactobacillus Ferment, Sodium Hydroxide

PRINCIPAL DISPLAY PANEL - 118mL Tube Carton

Label Images#

SunBurnt.601.PDP
SunBurnt.601.PDP

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1010077lidocaine HCl 4 % Topical GelPSN1
1010077lidocaine hydrochloride 0.04 MG/MG Topical GelSCD1
1010077lidocaine hydrochloride 4 % Topical GelSY1

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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
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
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68229-601-01SunBurnt PLUS118 mL in 1 TUBEGEL1181
68229-601-02SunBurnt PLUS1 in 1 CARTONGEL11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68229-601SUNBURNT PLUS (LIDOCAINE HYDROCHLORIDE) GEL [QUEST PRODUCTS, LLC.]1Current NDC, 2 package rows20240224_12128c75-015d-8a72-e063-6394a90ae00a.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68229-601-01ML - Milliliter68229-6018752e6f0-3db0-470b-8321-8e2cd6cf719812026-03-17
68229-601-02ML - Milliliter68229-601289e306d-c317-4ebd-b495-aa1dc0126e9e12026-03-17

Products#

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68229-60168229-601-01, 68229-601-02

Ingredients#

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
LIMOSILACTOBACILLUS FERMENTUM2C1F12C6APIACT
HYDROXYETHYL CELLULOSE (5500 MPA.S AT 2%)M825OX60H9IACT
PHENOXYETHANOLHIE492ZZ3TIACT
WATER059QF0KO0RIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
PANTHENOLWV9CM0O67ZIACT
HYALURONATE SODIUMYSE9PPT4THIACT
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR
ECHINACEA PURPUREA ROOTOS64WTR4KUIACT
GLYCERINPDC6A3C0OXIACT
MANNITOL3OWL53L36AIACT
SODIUM HYDROXIDE55X04QC32IIACT

Complete SPL Sections#

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine Hydrochloride 4%

Purpose

OTC - PURPOSE SECTION

Topical Pain Relief

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves pain and itching due to: sunburn minor burns insect bites minor skin irritations minor cuts scrapes

Warnings

WARNINGS SECTION

For external use only

Directions

DOSAGE & ADMINISTRATION SECTION

clean skin and apply to affected area adults and children 2 years of age and older: apply to affected area not more than 3-4 times daily children under 2 years of age: ask a doctor

Other Information

STORAGE AND HANDLING SECTION

store at 15-30°C (59-86°F) do not use if seal under cap is open or missing

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Hydroxyethylcellulose,Glycerin, Phenoxyethanol, Aloe Barbadensis Leaf Juice, D-Panthenol, Calunda Officinalis Extract, Echinacea Purpurea Root Extract, Mannitol, Sodium Hyaluronate, Lactobacillus Ferment, Sodium Hydroxide

PRINCIPAL DISPLAY PANEL - 118mL Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Source Document#

Source XML