KOA PROTECT OUR OCEAN LIFE OXYBENZONE FREE BROAD SPECTRUM SPF 30 UVA UVB PROTECTION SUNSCREEN- titanium dioxide, zinc oxide cream 
Kapa'ihi, Inc

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koa protect our ocean life OXYBENZONE-FREE Broad Spectrum SPF 30 UVA/UVB Protection Sunscreen

DRUG FACTS

Active Ingredients

Titanium Dioxide (6.00%)

Zinc Oxide (6.00%)

Purpose

Sunscreen

USES:

   Helps prevent sunburn. If used as directed with other sun protection measures (see directions) decreases the risk of skin cancer and early skin aging caused by the sun.

WARNINGS:

For external use only.

Do not use 

on damaged or broken skin.

When using this product 

keep out of eyes. Rinse with water to remove. 

Stop use and consult physician 

if irritation or rash develops. 

Keep out of reach of children.

If product is swallowed, get medical attention or contact poison control center immediately

DIRECTIONS:

Apply liberally 15-minutes before sun exposure. Reapply at least every two-hours or immediately after swimming. sweating or towel drying. SUN PROTECTION MEASURES, Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use sunscreen with broad spectrum protection and an SPF rating of 15 or higher, along with other sun protection measures including: - Wear long sleeve shirts, pants, hats and sunglasses. - For children under 6-months, consult a physician.

OTHER INGREDIENTS

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Butyrospermum Parkii (Shea) Butter, Camellia Sinensis (Green Tea) Extract, Cocos Nucifera (Coconut) Oil, Dehydroxanthan Gum, Gluconolactone, Glycerin, Glycine Soja (Soybean) Oil, Helianthus Annuus (Sunflower) Oil, Lecithin, Mangifera Indica (Mango) Seed Butter. Sodium Benzoate, Sodium Laurylglucosides Hydroxypropyl Sulfonate, Styrene/Acrylates Copolymer, Tocopherol Acetate (Vitamin E), Xanthan Gum.

Other Information:

Protect this product from excessive heat and direct sunlight

Package Labeling:

Label5

KOA PROTECT OUR OCEAN LIFE OXYBENZONE FREE BROAD SPECTRUM SPF 30 UVA UVB PROTECTION SUNSCREEN 
titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71889-350
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE60 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION60 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
WATER (UNII: 059QF0KO0R)  
SHEA BUTTER (UNII: K49155WL9Y)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
COCONUT OIL (UNII: Q9L0O73W7L)  
DEHYDROXANTHAN GUM (UNII: 63ZP7I1BQO)  
GLUCONOLACTONE (UNII: WQ29KQ9POT)  
GLYCERIN (UNII: PDC6A3C0OX)  
SOYBEAN OIL (UNII: 241ATL177A)  
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)  
MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71889-350-081 in 1 CARTON11/18/2017
1236 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02011/18/2017
Labeler - Kapa'ihi, Inc (080938084)

Revised: 11/2023
Document Id: 09dc25cb-c025-39aa-e063-6394a90a99b2
Set id: 66e5eb1b-4ef0-459d-8428-b3e2f221bc85
Version: 3
Effective Time: 20231111
 
Kapa'ihi, Inc