FDA.reportPublic FDA data

CVS Health Sunburn Relief Cooling Spray

Manufacturer
CVS PHARMACY
Effective date
2024-07-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:15:24

Label at a glance#

ProductCVS Health Sunburn Relief Cooling
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure12 sections

Indications and uses

Temporary relieves pain and itching associated with sunburn, minor burns, minor cuts, scrapes, insect bites, or , minor skin irritations

Dosage and administration

Adults and Children 2 Years of Age andAolder; Spray onto affected area not more than 3 to 4 times daily. To apply to face, spray in palm of hand and gently apply. Children Under 2 Years of Age: Ask a doctor.

Storage and handling

may stain some fabrics

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 0.5% (as Lidocaine HCl)

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

Temporary relieves pain and itching associated with sunburn, minor burns, minor cuts, scrapes, insect bites, or , 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

  • keep out of eyes. Rinse with water to remove.
  • do not puncture or incinerate. Contents under pressure.
  • do not store at temperatures above 120°F.

Stop use and ask a doctor if

OTC - ASK DOCTOR SECTION

  • condition gets worse
  • symptoms last more than 7 days
  • symptoms clear up and occur again in a few days

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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 andAolder; Spray onto affected area not more than 3 to 4 times daily. To apply to face, spray in palm of hand and gently apply.
  • Children Under 2 Years of Age: Ask a doctor.

Other information

STORAGE AND HANDLING SECTION

  • may stain some fabrics

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Juice, Aminomethyl Propanol, Benzophenone 4, Benzyl Alcohol, Carbomer, Isoceteth-20, Menthol, Phenoxyethanol, Polysorbate 20, Tetrasodium EDTA, Tocophorol.

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVS45738ACVS45738A

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1010931lidocaine HCl 0.5 % Topical SprayPSN1
1010931lidocaine hydrochloride 5 MG/ML Topical SpraySCD1
1010931lidocaine hydrochloride 0.5 % Topical SpraySY1

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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51316-066-25CVS Health Sunburn Relief Cooling170 g in 1 CANSPRAY1701

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51316-066CVS HEALTH SUNBURN RELIEF COOLING (LIDOCAINE HYDROCHLORIDE) SPRAY [CVS PHARMACY]1Current NDC, 1 package rows20240718_1d6402ea-4201-27f9-e063-6294a90a43f5.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51316-06651316-066-25

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYACRYLIC ACID (250000 MW)9G2MAD7J6WIACT
LEVOMENTHOLBZ1R15MTK7IACT
BENZYL ALCOHOLLKG8494WBHIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYSORBATE 207T1F30V5YHIACT
.ALPHA.-TOCOPHEROL, DL-7QWA1RIO01IACT
ALOE VERA LEAFZY81Z83H0XIACT
ISOCETETH-20O020065R7ZIACT
EDETATE SODIUMMP1J8420LUIACT
WATER059QF0KO0RIACT
SULISOBENZONE1W6L629B4KIACT
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR
AMINOMETHYLPROPANOLLU49E6626QIACT

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
CVS Health Sunburn Relief CoolingLIDOCAINE HYDROCHLORIDECVS PHARMACY1d6402ea-4201-27f9-e063-6294a90a43f52024-07-16WarningsExact identifier
ndc (package): 51316-066-25
ndc (product): 51316-066
ndc11 (package): 51316006625
spl id: 1d63d6e4-81ec-0a41-e063-6394a90ae83e
spl set id: 1d6402ea-4201-27f9-e063-6294a90a43f5

Reported adverse events (FAERS/openFDA)#

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