FDA.reportPublic FDA data

Caribbean Breeze SPF 15 Broad Spectrum Lip Balm

Manufacturer
Raining Rose, Inc
Effective date
2023-10-23
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:57:27

Label at a glance#

ProductCaribbean Breeze SPF 15 Broad Spectrum Lip Balm
Active ingredientOCTISALATE, AVOBENZONE, OCTOCRYLENE, OCTINOXATE
Label structure12 sections

Dosage and administration

Apply liberally 15 minutes before sun exposure Use a water resistant sunscreen if swimming or sweating Reapply at least every 2 hours Children under 6 months of age: Ask a doctor

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 2.0%

Octinoxate 6.5%

Octisalate 5.0%

Octocrylene 1.5%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin.

Stop Use and ask a doctor if

OTC - STOP USE SECTION

Rash Occurs

When Using this Product

OTC - WHEN USING SECTION

Keep out of eyes. Rinse well with water to remove.

Keep out of reach of children

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 right away.

Directions

ROUTE, METHOD AND FREQUENCY OF ADMINISTRATION

Apply liberally 15 minutes before sun exposure

Use a water resistant sunscreen if swimming or sweating

Reapply at least every 2 hours
Children under 6 months of age: Ask a doctor

Inactive ingredients:

INACTIVE INGREDIENT SECTION

Sunflower oil*, Beeswax, Olive Oil*, Flavor, Hemp Seed Oil*, Soybean Oil, Sunflower Seed Oil Glycerides, Rosemary Extract, Vitamin E, Aloe Extract, Canola Oil. * Organic

DOSAGE & ADMINISTRATION SECTION

Apply liberally 15 minutes before sun exposure

INDICATIONS & USAGE SECTION

Helps prevent sunburn

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

C10553 Caribbean Breeze Premium SPF 15 BS LBC10553 Caribbean Breeze Premium SPF 15 BS LB

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65692-0523-1Caribbean Breeze SPF 15 Broad Spectrum Lip Balm4.25 g in 1 TUBESTICK4.253

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65692-0523CARIBBEAN BREEZE SPF 15 BROAD SPECTRUM LIP BALM STICK [RAINING ROSE, INC]3Current NDC, Legacy NDC, 1 package rows20231024_a75a42f6-27d1-e2cc-e053-2a95a90aa6da.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
65692-052365692-0523-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
SUNFLOWER OIL3W1JG795YIIACT
TOCOPHEROLR0ZB2556P8IACT
ROSEMARYIJ67X351P9IACT
WHITE WAX7G1J5DA97FIACT
OLIVE OIL6UYK2W1W1EIACT
CANNABIS SATIVA SEED OIL69VJ1LPN1SIACT
ALOE VERA LEAFZY81Z83H0XIACT
OCTISALATE4X49Y0596WACTIB
AVOBENZONEG63QQF2NOXACTIB
OCTOCRYLENE5A68WGF6WMACTIB
OCTINOXATE4Y5P7MUD51ACTIB
CANOLA OIL331KBJ17RKIACT
SOYBEAN OIL241ATL177AIACT
SUNFLOWER OIL MONO/DIGLYCERIDESHS7EB0C1ZHIACT

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
Caribbean Breeze SPF 15 Broad Spectrum Lip BalmCARIBBEAN BREEZE SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inca75a42f6-27d1-e2cc-e053-2a95a90aa6da2023-10-23WarningsExact identifier
ndc (package): 65692-0523-1
ndc (product): 65692-0523
ndc11 (package): 65692052301
spl id: 0867b727-7fde-0080-e063-6394a90ad172
spl set id: a75a42f6-27d1-e2cc-e053-2a95a90aa6da

Reported adverse events (FAERS/openFDA)#

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