FDA.reportPublic FDA data

Broad Spectrum SPF 15 Sunscreen Fresh Berry Lip Balm

Manufacturer
Raining Rose, Inc | Raining Rose, Inc.
Effective date
2024-04-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:04:23

Label at a glance#

ProductBroad Spectrum SPF 15 Sunscreen Fresh Berry Lip Balm
Active ingredientOCTISALATE, OCTOCRYLENE, OCTINOXATE, AVOBENZONE
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 2.0%

Octinoxate 6.5%

Octisalate 5.0%

Octocrylene 1.5%

OTC - PURPOSE SECTION

Sunscreen

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

on damaged or broken skin .

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs

OTC - WHEN USING SECTION

Keep out of eyes. Rinse well 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.

INACTIVE INGREDIENT SECTION

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

DOSAGE & ADMINISTRATION SECTION

Apply liberally 15 mintues before sun exposure

INDICATIONS & USAGE SECTION

Helps prevent sunburn

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

2024-28350-00_Fresh Berry Premium SPF 15 BS LB_MU1 (002)2024-28350-00_Fresh Berry Premium SPF 15 BS LB_MU1 (002)

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65692-0576BROAD SPECTRUM SPF 15 SUNSCREEN FRESH BERRY LIP BALM (ROAD SPECTRUM SPF 15 SUNSCREEN FRESH BERRY LIP BALM) STICK [RAINING ROSE, INC]1Unmatched20240426_16ca3994-c488-2612-e063-6394a90af313.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
65692-057665692-0576-1

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
TOCOPHEROLR0ZB2556P8IACT
SUNFLOWER OIL3W1JG795YIIACT
CANNABIS SATIVA SEED OIL69VJ1LPN1SIACT
CANOLA OIL331KBJ17RKIACT
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
OLIVE OIL6UYK2W1W1EIACT
ALOE VERA LEAFZY81Z83H0XIACT
OCTINOXATE4Y5P7MUD51ACTIB
SUNFLOWER OIL MONO/DIGLYCERIDESHS7EB0C1ZHIACT
AVOBENZONEG63QQF2NOXACTIB
WHITE WAX7G1J5DA97FIACT
ROSEMARYIJ67X351P9IACT
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
4c221cfb-556e-43a7-e063-6294a90a139416ca3994-c488-2612-e063-6394a90af3132026-03-03WarningsExact identifier
spl set id: 16ca3994-c488-2612-e063-6394a90af313

Reported adverse events (FAERS/openFDA)#

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