FDA.reportPublic FDA data

Totally Fun After Sun

Manufacturer
MJ Products Association, LLC
Effective date
2023-11-15
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:02:15

Label at a glance#

ProductTotally Fun After Sun
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure8 sections

Dosage and administration

Adults and children two-years of age or older: Apply to affected area not more than three to four times daily. Children under two-years of age: consult a physician.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCL 1.50%

PURPOSE

OTC - PURPOSE SECTION

Topical Anesthetic

Indications

INDICATIONS & USAGE SECTION

For the Temporary relief of pain and itching due to sunburn, minor skin irritations, minor cuts, minor burns, scrapes and insect bites.

WARNINGS

WARNINGS SECTION

FOR EXTERNAL USE ONLY

Do not use

OTC - DO NOT USE SECTION

  • in large quantites, particularly over raw or blistered areas.
  • Avoid contact with eyes.

Stop use and ask a doctor

OTC - STOP USE SECTION

  • if condition gets worse, symptoms last for more than 7 days, or symptoms clear up and occur again with a few days.
  • If sumptoms persist for more than seven days, discontinue use and consult physician.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, consult physician.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children two-years of age or older: Apply to affected area not more than three to four times daily.
  • Children under two-years of age: consult a physician.

Additional information

SPL UNCLASSIFIED SECTION

Store at room temperature.

Other Ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Carbomer, Ethylhexylglycerin, : Polyethylene Terephthalate, Polymethyl Methacrylate, Polyurethan-33, FD&C Yellow #5, D&C Red #7; Parfum (Orange Fragrance), Phenoxyethanol, Terephthalate, Triethanolamine. Glitter

Questions or comments?

OTC - QUESTIONS SECTION

Contact us directly at 1-888-601-0441

Distr. by/par: Sunshine & Glitter

MJ Products Association LLC

9750 NW 17th Street,  Miami, FL 33172

www.sunshineglitter.com

All Rights Reserved.

Package Labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Totally Fun After SunTotally Fun After Sun

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2000538lidocaine hydrochloride 1.5 % Topical GelPSN4
2000538lidocaine hydrochloride 0.015 MG/MG Topical GelSCD4
2000538lidocaine hydrochloride 1.5 % Topical GelSY4

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72085-145-08Totally Fun After Sun236 mL in 1 BOTTLEGEL2364

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72085-145TOTALLY FUN AFTER SUN (LIDOCAINE HCL) GEL [MJ PRODUCTS ASSOCIATION, LLC]4Current NDC, Legacy NDC, 1 package rows20231116_965a2a29-914c-4ad0-b25f-5df3c30da393.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72085-14572085-145-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
CARBOXYPOLYMETHYLENE0A5MM307FCIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
POLY(METHYL METHACRYLATE; 450000 MW)Z47NNT4J11IACT
FD&C YELLOW NO. 5I753WB2F1MIACT
D&C RED NO. 7ECW0LZ41X8IACT
PHENOXYETHANOLHIE492ZZ3TIACT
TROLAMINE9O3K93S3TKIACT
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
Totally Fun After SunLIDOCAINE HCLMJ Products Association, LLC965a2a29-914c-4ad0-b25f-5df3c30da3932023-11-15WarningsExact identifier
ndc (package): 72085-145-08
ndc (product): 72085-145
ndc11 (package): 72085014508
spl id: 0a3b743f-7239-8cf5-e063-6294a90aecb2
spl set id: 965a2a29-914c-4ad0-b25f-5df3c30da393

Reported adverse events (FAERS/openFDA)#

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