FDA.reportPublic FDA data

Broad Spectrum SPF 30 Tropical Sunscreen

Manufacturer
Raining Rose, Inc
Effective date
2024-05-17
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:02:25

Label at a glance#

ProductBroad Spectrum SPF 30 Tropical Sunscreen
Active ingredientOCTISALATE, AVOBENZONE, OCTOCRYLENE, HOMOSALATE, OXYBENZONE
Label structure11 sections

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3.0%

Homosalate 7.5%

Octisalate 5.0%

Octocrylene 2.5%

Oxybenzone 6.0%

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.

Inactive ingredients:

INACTIVE INGREDIENT SECTION

Aloe Vera Leaf Juice, Cetearyl Alcohol, Cetearyl Glucoside, Citric Acid, Fragrance, Glycerin, Glyceryl Stearate SE, Grapeseed Oil, Methylparaben, Potassium Sorbate, Propylparaben, Soybean Oil, Sunflower Oil, Sweet Amond Oil, Tocopherol, Water, Xanthan Gum.

DOSAGE & ADMINISTRATION SECTION

Apply liberally 15 minutes before sun exposure

INDICATIONS & USAGE SECTION

Helps prevent sunburn

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

C10458 1 FLOZ SPF 30 BS TROPICAL SUNSCREENC10458 1 FLOZ SPF 30 BS TROPICAL SUNSCREEN

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65692-0517BROAD SPECTRUM SPF 30 TROPICAL SUNSCREEN LOTION [RAINING ROSE, INC]4Legacy NDC20240518_a357b789-2b65-3975-e053-2a95a90ab7a8.zip

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
65692-051765692-0517-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
SOYBEAN OIL241ATL177AIACT
METHYLPARABENA2I8C7HI9TIACT
GRAPE SEED OIL930MLC8XGGIACT
TOCOPHEROLR0ZB2556P8IACT
CETEARYL GLUCOSIDE09FUA47KNAIACT
CETYL ALCOHOL936JST6JCNIACT
GLYCERINPDC6A3C0OXIACT
ALOE VERA LEAFZY81Z83H0XIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
OCTISALATE4X49Y0596WACTIB
AVOBENZONEG63QQF2NOXACTIB
OCTOCRYLENE5A68WGF6WMACTIB
HOMOSALATEV06SV4M95SACTIB
OXYBENZONE95OOS7VE0YACTIB
PROPYLPARABENZ8IX2SC1OHIACT
XANTHAN GUMTTV12P4NEEIACT
SUNFLOWER OIL3W1JG795YIIACT
ALMOND OIL66YXD4DKO9IACT
WATER059QF0KO0RIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
GLYCERYL STEARATE SEFCZ5MH785IIACT

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
18acb56f-79ff-cdeb-e063-6394a90ab2d3a357b789-2b65-3975-e053-2a95a90ab7a82024-05-17WarningsExact identifier
spl id: 18acb56f-79ff-cdeb-e063-6394a90ab2d3
spl set id: a357b789-2b65-3975-e053-2a95a90ab7a8

Reported adverse events (FAERS/openFDA)#

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