Koa Protect Our Ocean Life Oxybenzone-free Broad Spectrum Spf 30 Uva/uvb Protection Sunscreen

Koa Protect Our Ocean Life Oxybenzone-free Broad Spectrum Spf 30 Uva/uvb Protection Sunscreen
SPL v3
SPL
SPL Set ID 66e5eb1b-4ef0-459d-8428-b3e2f221bc85
Route
TOPICAL
Published
Effective Date 2017-11-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (60 mg) Zinc Cation
Inactive Ingredients
Aloe Vera Leaf Water Shea Butter Green Tea Leaf Coconut Oil Dehydroxanthan Gum Gluconolactone Glycerin Soybean Oil Helianthus Annuus Flowering Top Mangifera Indica Seed Butter Sodium Benzoate .alpha.-tocopherol Acetate Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-11-18

Description

Titanium Dioxide (6.00%) Zinc Oxide (6.00%)

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Titanium Dioxide (6.00%) Zinc Oxide (6.00%)

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.

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.

Do Not Use 

on damaged or broken skin.

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.

Package Labeling:

Active Ingredients

Titanium Dioxide (6.00%)

Zinc Oxide (6.00%)

Other Information:

Protect this product from excessive heat and direct sunlight

When Using This Product 

keep out of eyes. Rinse with water to remove. 

Keep Out of Reach of Children.

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

Stop Use and Consult Physician 

if irritation or rash develops. 


Structured Label Content

Uses: (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.

Purpose

Sunscreen

Warnings: (WARNINGS:)

For external use only.

Directions: (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.

Do Not Use  (Do not use )

on damaged or broken skin.

Other Ingredients (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.

Package Labeling:

Active Ingredients

Titanium Dioxide (6.00%)

Zinc Oxide (6.00%)

Other Information:

Protect this product from excessive heat and direct sunlight

When Using This Product  (When using this product )

keep out of eyes. Rinse with water to remove. 

Keep Out of Reach of Children. (Keep out of reach of children.)

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

Stop Use and Consult Physician  (Stop use and consult physician )

if irritation or rash develops. 


Advanced Ingredient Data


Raw Label Data

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