FDA.reportPublic FDA data

Broad Spectrum SPF 15 Sunscreen Vanilla Lip Balm

Manufacturer
Raining Rose
Effective date
2023-10-17
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:56:53

Label at a glance#

ProductBroad Spectrum SPF 15 Sunscreen Vanilla Lip Balm
Active ingredientAVOBENZONE, OCTINOXATE, OCTOCRYLENE, OCTISALATE
Label structure12 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients:

Avobenzone 3.0%

Octinoxate 6.5%

Octisalate 5.0%

Octocrylene 1.5%

OTC - PURPOSE SECTION

Purpose

Sunscreen

WARNINGS SECTION

Warnings

For external use only.

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

OTC - ASK DOCTOR SECTION

Stop use and ask doctor if rash occurs

OTC - WHEN USING SECTION

When using this product keep out of eyes. Rinse with water to remove.

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.

ROUTE, METHOD AND FREQUENCY OF ADMINISTRATION

Directions: Apply liberally 15 mintues 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 INGREDIENT SECTION

Inactive Ingredients: Petrolatum, Mineral Oil, Paraffin Wax,
Flavor, Ozokerite Wax, Coconut Oil, Tocopherol, Soybean Oil.

DOSAGE & ADMINISTRATION SECTION

Apply liberally 15 minutes before sun exposure.

INDICATIONS & USAGE SECTION

Helps prevent sunburn

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

C11075 Vanilla Value SPF 15 BS LB V2C11075 Vanilla Value SPF 15 BS LB V2

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
65692-0575-1Broad Spectrum SPF 15 Sunscreen Vanilla Lip Balm4.25 g in 1 TUBESTICK4.252

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65692-0575BROAD SPECTRUM SPF 15 SUNSCREEN VANILLA LIP BALM STICK [RAINING ROSE]2Current NDC, 1 package rows20231018_efe27e7e-e805-1c47-e053-2995a90af22e.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
65692-057565692-0575-1

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
WHITE PETROLATUMB6E5W8RQJ4IACT
PARAFFINI9O0E3H2ZEIACT
AVOBENZONEG63QQF2NOXACTIB
SOYBEAN OIL241ATL177AIACT
OCTINOXATE4Y5P7MUD51ACTIB
CERESINQ1LS2UJO3AIACT
OCTOCRYLENE5A68WGF6WMACTIB
OCTISALATE4X49Y0596WACTIB
COCONUT OILQ9L0O73W7LIACT
MINERAL OILT5L8T28FGPIACT
TOCOPHEROLR0ZB2556P8IACT

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
Broad Spectrum SPF 15 Sunscreen Vanilla Lip BalmBROAD SPECTRUM SPF 15 SUNSCREEN VANILLA LIP BALMRaining Roseefe27e7e-e805-1c47-e053-2995a90af22e2023-10-17WarningsExact identifier
ndc (package): 65692-0575-1
ndc (product): 65692-0575
ndc11 (package): 65692057501
spl id: 07f09e4d-42e8-0e3a-e063-6294a90a9723
spl set id: efe27e7e-e805-1c47-e053-2995a90af22e

Reported adverse events (FAERS/openFDA)#

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