FDA.reportPublic FDA data

Vanilla SPF 15 Lip

Manufacturer
Raining Rose, Inc.
Effective date
2017-12-27
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 22:53:47

Label at a glance#

ProductSpearmint SPF 15 Lip
Active ingredientAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE
Label structure12 sections

Indications and uses

Helps prevent sunburn

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 Sun Protection Measures Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad Spectrum SPF value of 15 or higher and other sun protection measure...

Label contents#

Full prescribing information#

PEEL HERE FOR DRUG FACTS Broad Spectrum SPF 15 Sunscreen Spearmint Lip Balm, Beeswax Lip Balm, Pomegranate Lip Balm, Tropical Lip Balm, Vanilla Lip Balm Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients:
Avobenzone 2.0%
Octinoxate 6.5%
Octsalate 5.0%
Octocrylene 1.5%

Purpose

OTC - PURPOSE SECTION

Sunscreen

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.

Uses

INDICATIONS & USAGE SECTION

Helps prevent sunburn

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

OTC - STOP USE SECTION

if rash occurs

When using this product

OTC - WHEN USING SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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
Sun Protection Measures Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad Spectrum SPF value of 15 or higher and other sun protection measures including limit time in the sun, especially from 10a.m. - 2p.m.  wear long sleeved shirts, pants, hats, and sunglasses.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Sunflower oil*, beeswax, extra virgin olive oil*, hemp seed oil*, rosemary extract, vitamin E, aloe vera
*Certified Organic

Other Information

OTHER SAFETY INFORMATION

Protect this product from excessive heat and direct sun.

Product Label Spearmint Lip Balm Beeswax Lip Balm Pomegranate Lip Balm Tropical Lip Balm Vanilla Lip Balm

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dist. by: Raining Rose, Inc. Cedar Rapids IA 52403    L000000

PEEL HERE FOR DRUG FACTS
Broad Spectrum SPF Sunscreen

NetWt. .15 oz

Spearmint Lip Balm
Beeswax Lip Balm
Pomegranate Lip Balm
Tropical Lip Balm
Vanilla Lip Balm


RR Spearmint LB LabelRR Spearmint LB Label


RR Beeswax LB LabelRR Beeswax LB Label


RR Pomegranate LB LabelRR Pomegranate LB Label


RR Tropical LB LabelRR Tropical LB Label

RR Vanilla LB LabelRR Vanilla LB Label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
65692-0301-12021-01-29C16284748780-1ba0f9c33-0e1d-a910-e053-dadaa90a0b85ade670ee-de2f-4b9a-8b4e-7fdcb73af798
65692-0302-12021-01-29C16284748780-1ba0f9c33-0e1d-a910-e053-dadaa90a0b85ade670ee-de2f-4b9a-8b4e-7fdcb73af798
65692-0303-12021-01-29C16284748780-1ba0f9c33-0e1d-a910-e053-dadaa90a0b85ade670ee-de2f-4b9a-8b4e-7fdcb73af798
65692-0304-12021-01-29C16284748780-1ba0f9c33-0e1d-a910-e053-dadaa90a0b85ade670ee-de2f-4b9a-8b4e-7fdcb73af798
65692-0305-12021-01-29C16284748780-1ba0f9c33-0e1d-a910-e053-dadaa90a0b85ade670ee-de2f-4b9a-8b4e-7fdcb73af798

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65692-0301-1Spearmint SPF 15 Lip4.25 g in 1 PACKAGESTICK4.253
65692-0302-1Beeswax SPF 15 Lip4.25 g in 1 PACKAGESTICK4.253
65692-0303-1Pomegranate SPF 15 Lip4.25 g in 1 PACKAGESTICK4.253
65692-0304-1Tropical SPF 15 Lip4.25 g in 1 PACKAGESTICK4.253
65692-0305-1Vanilla SPF 15 Lip4.25 g in 1 PACKAGESTICK4.253

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65692-0301SPEARMINT SPF 15 LIP (AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE) STICK BEESWAX SPF 15 LIP (AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE) STICK POMEGRANATE SPF 15 LIP (AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE) STICK TROPICAL SPF 15 LIP (AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE) STICK VANILLA SPF 15 LIP (AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE) STICK [RAINING ROSE, INC.]3Legacy NDC, 1 package rows20171228_ade670ee-de2f-4b9a-8b4e-7fdcb73af798.zip
65692-0302SPEARMINT SPF 15 LIP (AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE) STICK BEESWAX SPF 15 LIP (AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE) STICK POMEGRANATE SPF 15 LIP (AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE) STICK TROPICAL SPF 15 LIP (AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE) STICK VANILLA SPF 15 LIP (AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE) STICK [RAINING ROSE, INC.]3Legacy NDC, 1 package rows20171228_ade670ee-de2f-4b9a-8b4e-7fdcb73af798.zip
65692-0303SPEARMINT SPF 15 LIP (AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE) STICK BEESWAX SPF 15 LIP (AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE) STICK POMEGRANATE SPF 15 LIP (AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE) STICK TROPICAL SPF 15 LIP (AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE) STICK VANILLA SPF 15 LIP (AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE) STICK [RAINING ROSE, INC.]3Legacy NDC, 1 package rows20171228_ade670ee-de2f-4b9a-8b4e-7fdcb73af798.zip
65692-0304SPEARMINT SPF 15 LIP (AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE) STICK BEESWAX SPF 15 LIP (AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE) STICK POMEGRANATE SPF 15 LIP (AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE) STICK TROPICAL SPF 15 LIP (AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE) STICK VANILLA SPF 15 LIP (AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE) STICK [RAINING ROSE, INC.]3Legacy NDC, 1 package rows20171228_ade670ee-de2f-4b9a-8b4e-7fdcb73af798.zip
65692-0305SPEARMINT SPF 15 LIP (AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE) STICK BEESWAX SPF 15 LIP (AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE) STICK POMEGRANATE SPF 15 LIP (AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE) STICK TROPICAL SPF 15 LIP (AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE) STICK VANILLA SPF 15 LIP (AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE) STICK [RAINING ROSE, INC.]3Legacy NDC, 1 package rows20171228_ade670ee-de2f-4b9a-8b4e-7fdcb73af798.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOX2
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD512
OCTISALATEACTIVE INGREDIENT4X49Y0596W2
OCTOCRYLENEACTIVE INGREDIENT5A68WGF6WM2
AVOBENZONEACTIVE MOIETYG63QQF2NOX2
OCTINOXATEACTIVE MOIETY4Y5P7MUD512
OCTISALATEACTIVE MOIETY4X49Y0596W2
OCTOCRYLENEACTIVE MOIETY5A68WGF6WM2
.ALPHA.-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ12
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0X2
CANNABIS SATIVA SEED OILINACTIVE INGREDIENT69VJ1LPN1S2
OLIVE OILINACTIVE INGREDIENT6UYK2W1W1E2
ROSEMARYINACTIVE INGREDIENTIJ67X351P92
SPEARMINTINACTIVE INGREDIENTJ7I2T6IV1N2
SUNFLOWER OILINACTIVE INGREDIENT3W1JG795YI2
YELLOW WAXINACTIVE INGREDIENT2ZA36H0S2V2

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
65692-030165692-0301-1
65692-030565692-0305-1
65692-030265692-0302-1
65692-030365692-0303-1
65692-030465692-0304-1

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 56 matching rows.

Name, UNII, Kind table
NameUNIIKind
SUNFLOWER OIL3W1JG795YIIACT
YELLOW WAX2ZA36H0S2VIACT
OLIVE OIL6UYK2W1W1EIACT
SPEARMINTJ7I2T6IV1NIACT
CANNABIS SATIVA SEED OIL69VJ1LPN1SIACT
ROSEMARYIJ67X351P9IACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
ALOE VERA LEAFZY81Z83H0XIACT
AVOBENZONEG63QQF2NOXACTIB
OCTINOXATE4Y5P7MUD51ACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
SUNFLOWER OIL3W1JG795YIIACT
YELLOW WAX2ZA36H0S2VIACT
OLIVE OIL6UYK2W1W1EIACT
CANNABIS SATIVA SEED OIL69VJ1LPN1SIACT
ROSEMARYIJ67X351P9IACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
ALOE VERA LEAFZY81Z83H0XIACT
AVOBENZONEG63QQF2NOXACTIB
OCTINOXATE4Y5P7MUD51ACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
SUNFLOWER OIL3W1JG795YIIACT
YELLOW WAX2ZA36H0S2VIACT
OLIVE OIL6UYK2W1W1EIACT
CANNABIS SATIVA SEED OIL69VJ1LPN1SIACT
ROSEMARYIJ67X351P9IACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
ALOE VERA LEAFZY81Z83H0XIACT
AVOBENZONEG63QQF2NOXACTIB
OCTINOXATE4Y5P7MUD51ACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
SUNFLOWER OIL3W1JG795YIIACT
YELLOW WAX2ZA36H0S2VIACT
OLIVE OIL6UYK2W1W1EIACT
CANNABIS SATIVA SEED OIL69VJ1LPN1SIACT
ROSEMARYIJ67X351P9IACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 28 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
YELLOW WAXYELLOW WAX2ZA36H0S2VOINTMENT / TOPICAL20 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VCREAM / TOPICAL5 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VTABLET, COATED / ORAL213.7 mgExact identifier — unii candidate
9 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1SOLUTION / ORAL1.05 mg/1mlExact identifier — unii candidate
10 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1SYSTEM / TOPICAL0.1 mgExact identifier — unii candidate
10 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VTABLET / ORAL3.22 mgExact identifier — unii candidate
9 equally ranked IID candidates
SPEARMINTSPEARMINTJ7I2T6IV1NTABLET, ORALLY DISINTEGRATING / ORAL0.06 mgExact identifier — unii candidate
4 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1TABLET, EXTENDED RELEASE / ORAL4 mgExact identifier — unii candidate
10 equally ranked IID candidates
SPEARMINTSPEARMINTJ7I2T6IV1NTABLET / ORAL0.09 mgExact identifier — unii candidate
4 equally ranked IID candidates
SPEARMINTSPEARMINTJ7I2T6IV1NSOLUTION / ORAL0.04 ml/5mlExact identifier — unii candidate
4 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS0.64 mgExact identifier — unii candidate
10 equally ranked IID candidates
OLIVE OILOLIVE OIL6UYK2W1W1ESOLUTION / ORAL425 mg/1mlExact identifier — unii candidate
5 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VTABLET, DELAYED RELEASE / ORAL0.1 mgExact identifier — unii candidate
9 equally ranked IID candidates
OLIVE OILOLIVE OIL6UYK2W1W1ECAPSULE / ORALNAExact identifier — unii candidate
5 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1FILM, SOLUBLE / BUCCAL0.07 mgExact identifier — unii candidate
10 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1TABLET, CHEWABLE / ORAL0.1 mgExact identifier — unii candidate
10 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1TABLET / ORAL2 mgExact identifier — unii candidate
10 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VCAPSULE, EXTENDED RELEASE / ORAL80.67 mgExact identifier — unii candidate
9 equally ranked IID candidates
OLIVE OILOLIVE OIL6UYK2W1W1ESOAP / TOPICALNAExact identifier — unii candidate
5 equally ranked IID candidates
OLIVE OILOLIVE OIL6UYK2W1W1ELOTION / TOPICAL32468 mgExact identifier — unii candidate
5 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1TABLET, FILM COATED / ORAL246 mgExact identifier — unii candidate
10 equally ranked IID candidates
OLIVE OILOLIVE OIL6UYK2W1W1ESOLUTION / TOPICAL0.6 %w/wExact identifier — unii candidate
5 equally ranked IID candidates
SPEARMINTSPEARMINTJ7I2T6IV1NTABLET, CHEWABLE / ORAL2.1 mgExact identifier — unii candidate
4 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1OINTMENT / TOPICALNAExact identifier — unii candidate
10 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VTABLET, EXTENDED RELEASE / ORAL0.01 mgExact identifier — unii candidate
9 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VCAPSULE / ORAL44 mgExact identifier — unii candidate
9 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1CAPSULE / ORAL16 mgExact identifier — unii candidate
10 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VTABLET, SUGAR COATED / ORALNAExact identifier — unii candidate
9 equally ranked IID candidates

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
615914d2-bd21-4048-e053-2991aa0a41d8ade670ee-de2f-4b9a-8b4e-7fdcb73af7982017-12-27WarningsExact identifier
spl id: 615914d2-bd21-4048-e053-2991aa0a41d8
spl set id: ade670ee-de2f-4b9a-8b4e-7fdcb73af798

Reported adverse events (FAERS/openFDA)#

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