Sun basics

Manufacturer
Prime Enterprises Inc.
Effective date
2020-06-08
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:27:28

Label at a glance#

ProductSun basics Burn Relief Gel with Lidocaine
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure8 sections

Indications and uses

For the temporary relief of pain associated with sunburn, insect bites, and 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

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of pain associated with sunburn, insect bites, and minor skin irritations.

WARNINGS SECTION

For external use only.

When using this product Avoid contact with eyes

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

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

Keep out of reach of children.

If product is swallowed, get medical help or contact a poison control center right away

OTC - WHEN USING SECTION

When using this product

  • Avoid contact with the eyes. If contact occurs, rinse thoroughly with water.

OTC - DO NOT USE SECTION

Do not use

  • in large quantities, particularly over raw surfaces or blistered areas.

OTC - ASK DOCTOR SECTION

Stop use and contact a physician

  • If irritation occurs.
  • If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

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 immediately.

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, Blue 1, Carbomer, Disodium EDTA, Ethylhexylglycerin, Fragrance, Menthol, Phenoxyethanol, Polysorbate 20, Propylene Glycol, SD Alcohol 40-B, Sodium Hydroxide, Yellow 5, Water

Questions or Comments?

OTC - QUESTIONS SECTION

Biocycle Laboratories, Inc.

16363 BW 48 Avenue,

Miami, FL 33014

SUN basics Burn Relief with Lidocaine

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Pincipal Display LabelPincipal Display Label

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58443-029858443-0298-5

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

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
dec237f6-b22f-0c0c-e053-2995a90a1d47a4d30cd9-8f8d-5a39-e053-2995a90ae52b2022-05-11WarningsExact identifier
spl set id: a4d30cd9-8f8d-5a39-e053-2995a90ae52b

Reported adverse events (FAERS/openFDA)#

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