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Drug Facts
Big Island Basics
FDA Label NDC 65692-1005
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Raining Rose, Inc. for the product Big Island Basics (NDC 65692-1005). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, otc - active ingredient, otc - purpose, indications & usage, warnings, dosage & administration, inactive ingredient, other safety information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Active Ingredients
Avobenzone 2.0%
Octinoxate 6.5%
Octisalate 5.0%
Octocrylene 1.5%
Otc - Purpose
Purpose
Avobenzone Sunscreen
Octinoxate Sunscreen
Octisalate Sunscreen
Octocrylene Sunscreen
Indications & Usage
Uses • Helps prevent sunburn
Warnings
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
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
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
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
res
* Please review the disclaimer below.
