Ocean Potion Suncare Ice Plus Pain Relieving Soothing Gel

Manufacturer
GNL BRANDS INTERNATIONAL, LLC
Effective date
2025-08-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:10:35

Label at a glance#

ProductOcean Potion Suncare Ice Plus Pain Relieving Soothing
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure11 sections

Indications and uses

For the temporary relief of pain and itching associated with sunburn, minor burns, minor cuts, scrapes, 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 ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 0.8% (as Lidocaine HCI)

Purpose

OTC - PURPOSE SECTION

External Analgesic

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For External Use Only

Do not use

OTC - DO NOT USE SECTION

in large quantities, particularly over raw surfaces or blistered areas

When using this product

OTC - WHEN USING SECTION

avoid contact with eyes. If contact occurs, rinse with water to remove.

Stop use and ask a doctor if

OTC - STOP USE SECTION

• condition worsens • symptoms persist for more than 7 days • symptoms clear up and occur again within a few days

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, seek 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 ingredients

INACTIVE INGREDIENT SECTION

aleurites moluccanus seed extract, allantoin, aloe barbadensis leaf juice, benzyl alcohol, blue 1, carbomer, carica papaya (papaya) fruit extract, colocasia antiquorum root extract, disodium EDTA, fragrance, glycerin, laureth-23, mangifera indica (mango) fruit extract, menthol, menthyl lactate, passiflora incarnata flower extract, phenoxyethanol, plumeria acutifolia flower extract, polysorbate 20, propylene glycol, psidium guajava fruit extract, SD alcohol 40-B, tocopherol, tocopheryl acetate (vitamin e), triethanolamine, water.

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

OP86069EOP86069E

OP86069FOP86069F

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1098616lidocaine 0.8 % Topical GelPSN1
1098616lidocaine 0.008 MG/MG Topical GelSCD1
1098616lidocaine 0.8 % 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
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85638-005-55Ocean Potion Suncare Ice Plus Pain Relieving Soothing243 g in 1 BOTTLEGEL2431

Products#

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

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85638-00585638-005-55

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 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
Ocean Potion Suncare Ice Plus Pain Relieving SoothingLIDOCAINEGNL BRANDS INTERNATIONAL, LLC3c69654c-cba6-dfef-e063-6394a90ad4792025-08-15WarningsExact identifier
ndc (package): 85638-005-55
ndc (product): 85638-005
ndc11 (package): 85638000555
spl id: 3c69654c-cba7-dfef-e063-6394a90ad479
spl set id: 3c69654c-cba6-dfef-e063-6394a90ad479

Reported adverse events (FAERS/openFDA)#

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