FDA.reportPublic FDA data

Big Island Basics

Manufacturer
Raining Rose, Inc.
Effective date
2020-04-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:05:47

Label at a glance#

ProductBig Island Basics
Active ingredientAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE
Label structure9 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients
Avobenzone    2.0%
Octinoxate      6.5%
Octisalate       5.0%
Octocrylene    1.5%

OTC - PURPOSE SECTION

Purpose

Avobenzone      Sunscreen
Octinoxate        Sunscreen
Octisalate         Sunscreen
Octocrylene      Sunscreen

INDICATIONS & USAGE SECTION

Uses • Helps prevent sunburn

WARNINGS SECTION

Warnings
For external use only • Do not use on damaged or broken skin.
Stop use and ask a doctor if rash occurs. When using this
product keep out of eyes.  Rinse with water to remove.
Keep out of reach of children. If swallowed get medical help
or contact Poison Control Center right away. For children
under 6 months of age ask a doctor before use.

DOSAGE & ADMINISTRATION SECTION

Directions

•Apply liberally 15 minutes before sun exposure
• Reapply at least every 2 hours
• Use a water resistant sunscreen if swimming or sweating

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 10 a.m. - 2 p.m. wear long-sleeved shirts, pants,
hats, and sunglasses

INACTIVE INGREDIENT SECTION

Inactive Ingredients
Sunflower Oil*, Beeswax, Extra Virgin Olive Oil*, Flavor, Tocopherol,
Hemp Seed Oil*, Rosemary Leaf Extract, Aloe Vera Leaf Extract, Soybean
Oil, Sunflower Seed Oil Glycerides, Canola Oil, *Certified Organic

OTHER SAFETY INFORMATION

Other Information: Protect this product from excessive
heat and sun.

Principal Display Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BIG
ISLAND
BASICS

LIP
BALM

VINTAGE PARADISE

NET WT .60 OZ/17G

For external use only

Broad Spectrum SPF 15 Sunscreen
Lip Balm

Made for Zodax, Panorama City, CA 91402

Distributed by Tommy Bahana Group, Inc. Seattle, WA 98109

L341677

TB TubeTB Tube

res

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
65692-1005-12024-01-30C16284748780-11030e365-53ba-111a-e063-dadaa90a10e2Big Island Basics Lip Balm SPF 15 Sunscreen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65692-1005-1Big Island Basics17 g in 1 TUBESTICK171

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65692-1005BIG ISLAND BASICS (AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE) STICK [RAINING ROSE, INC.]1Legacy NDC, 1 package rows20200411_07b5cec6-3bf9-48ba-a945-5c560e7535dd.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
65692-100565692-1005-1

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
AVOBENZONEG63QQF2NOXACTIB
OCTINOXATE4Y5P7MUD51ACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
SUNFLOWER OIL3W1JG795YIIACT
YELLOW WAX2ZA36H0S2VIACT
OLIVE OIL6UYK2W1W1EIACT
TOCOPHEROLR0ZB2556P8IACT
CANNABIS SATIVA SEED OIL69VJ1LPN1SIACT
ROSEMARYIJ67X351P9IACT
ALOE VERA LEAFZY81Z83H0XIACT
SOYBEAN OIL241ATL177AIACT
SUNFLOWER OIL MONOGLYCERIDESZVW8EIZ3IEIACT
CANOLA OIL331KBJ17RKIACT

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
b8a434e1-8766-4e59-bed9-880d2f5122ab07b5cec6-3bf9-48ba-a945-5c560e7535dd2020-04-10WarningsExact identifier
spl id: b8a434e1-8766-4e59-bed9-880d2f5122ab
spl set id: 07b5cec6-3bf9-48ba-a945-5c560e7535dd

Reported adverse events (FAERS/openFDA)#

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