BIG ISLAND BASICS- avobenzone, octinoxate, octisalate, octocrylene stick 
Raining Rose, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Big Island Basics Lip Balm SPF 15 Sunscreen

Drug Facts

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

Purpose

Avobenzone      Sunscreen
Octinoxate        Sunscreen
Octisalate         Sunscreen
Octocrylene      Sunscreen

Uses • Helps prevent sunburn

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.

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 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 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

TB Tube

res

BIG ISLAND BASICS 
avobenzone, octinoxate, octisalate, octocrylene stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65692-1005
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE20 mg  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE65 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE15 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
SUNFLOWER OIL (UNII: 3W1JG795YI)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
TOCOPHEROL (UNII: R0ZB2556P8)  
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
ROSEMARY (UNII: IJ67X351P9)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
SOYBEAN OIL (UNII: 241ATL177A)  
SUNFLOWER OIL MONOGLYCERIDES (UNII: ZVW8EIZ3IE)  
CANOLA OIL (UNII: 331KBJ17RK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65692-1005-117 g in 1 TUBE; Type 0: Not a Combination Product04/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35204/01/2020
Labeler - Raining Rose, Inc. (083819404)
Registrant - Raining Rose, Inc. (083819404)

Revised: 4/2020
Document Id: b8a434e1-8766-4e59-bed9-880d2f5122ab
Set id: 07b5cec6-3bf9-48ba-a945-5c560e7535dd
Version: 1
Effective Time: 20200410
 
Raining Rose, Inc.