FDA.reportPublic FDA data

Spearmint SPF 30 Broad Spectrum Lip Balm

Manufacturer
Raining Rose, Inc
Effective date
2023-10-23
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:57:30

Label at a glance#

ProductSpearmint SPF 30 Broad Spectrum Lip Balm
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE
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

Beeswax, coconut oil, castor oil, shea butter, cocoa butter, spearmint oil

DOSAGE & ADMINISTRATION SECTION

Apply liberally 15 minutes befroe sun exposure

INDICATIONS & USAGE SECTION

Helps prevent sunburn

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

C10735 SPEARMINT PREMIUM SPF 30 BS LBC10735 SPEARMINT PREMIUM SPF 30 BS LB

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65692-0556-1Spearmint SPF 30 Broad Spectrum Lip Balm4.25 g in 1 TUBESTICK4.252

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65692-0556SPEARMINT SPF 30 BROAD SPECTRUM LIP BALM STICK [RAINING ROSE, INC]2Current NDC, Legacy NDC, 1 package rows20231024_b7b520dc-bae6-614f-e053-2995a90ae677.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
65692-055665692-0556-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
SPEARMINT OILC3M81465G5IACT
COCOA BUTTER512OYT1CRRIACT
SHEA BUTTERK49155WL9YIACT
WHITE WAX7G1J5DA97FIACT
COCONUT OILQ9L0O73W7LIACT
CASTOR OILD5340Y2I9GIACT
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
OXYBENZONE95OOS7VE0YACTIB

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
Spearmint SPF 30 Broad Spectrum Lip BalmSPEARMINT SPF 30 BROAD SPECTRUM LIP BALMRaining Rose, Incb7b520dc-bae6-614f-e053-2995a90ae6772023-10-23WarningsExact identifier
ndc (package): 65692-0556-1
ndc (product): 65692-0556
ndc11 (package): 65692055601
spl id: 08654a71-51cd-1591-e063-6394a90ab5e4
spl set id: b7b520dc-bae6-614f-e053-2995a90ae677

Reported adverse events (FAERS/openFDA)#

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