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

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

Drug Labeling and Warnings

koa protect our ocean life OXYBENZONE FREE Broad Spectrum SPF 30 UVA UVB Protection Sunscreen by is a Otc medication manufactured, distributed, or labeled by Kapa'ihi, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71889-350
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	60 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	60 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71889-350-08	1 in 1 CARTON	11/18/2017
1		236 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	11/18/2017

Labeler - Kapa'ihi, Inc (080938084)