FDA.reportPublic FDA data

Grapefruit Shandy SPF 15 Broad Spectrum Lip Balm

Manufacturer
Raining Rose, Inc
Effective date
2021-02-09
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:53:41

Label at a glance#

ProductGrapefruit Shandy SPF 15 Broad Spectrum Lip Balm
Active ingredientOCTISALATE, AVOBENZONE, OCTOCRYLENE, OCTINOXATE
Label structure10 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*, Rosemary Extract, Tocopherol, Aloe Extract, Canola Oil, Soybean Oil, Sunflower Seed Oil Glycerides. * Organic

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

C10825 SPF 15 BS GRAPEFRUIT SHANDYC10825 SPF 15 BS GRAPEFRUIT SHANDY

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
65692-050765692-0507-1

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
CANOLA OIL331KBJ17RKIACT
OCTISALATE4X49Y0596WACTIB
AVOBENZONEG63QQF2NOXACTIB
OCTOCRYLENE5A68WGF6WMACTIB
OCTINOXATE4Y5P7MUD51ACTIB
SUNFLOWER OIL MONO/DIGLYCERIDESHS7EB0C1ZHIACT
SOYBEAN OIL241ATL177AIACT

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
cfd1080a-0bb5-3b9a-e053-2995a90a4dcea098050a-c4d2-750e-e053-2a95a90a4e412021-11-02WarningsExact identifier
spl set id: a098050a-c4d2-750e-e053-2a95a90a4e41

Reported adverse events (FAERS/openFDA)#

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