Coralsafe Broad Spectrum Spf30

Coralsafe Broad Spectrum Spf30
SPL v2
SPL
SPL Set ID e6e00896-b7e5-41c6-a72b-08e600758cf5
Route
TOPICAL
Published
Effective Date 2018-05-25
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 Mango Sodium Benzoate .alpha.-tocopherol Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-06-01

Description

Titanium Dioxide (6.0%) Zinc Oxide (6.0%)

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Titanium Dioxide (6.0%) Zinc Oxide (6.0%)

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.

Directions:

• Apply liberally 15 minutes before sun exposure • Reapply • After 80 minutes of swimming or sweating • Immediately after towel drying • At least every 2 hours • 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 of 15 or higher and other sun protection measures including: Sun Protection Measures:

• Limiting time in the sun, especially from 10 am - 2 pm. • Wearing long-sleeve shirts, pants, hats and sunglasses • Children under 6 months: Ask a doctor

Package Labeling:

Active Ingredients

Titanium Dioxide (6.0%)

Zinc Oxide (6.0%)

Other Information:

Protect this product from excessive heat and direct sun.

Inactive Ingredients:

Aloe Barbadensis (Aloe Vera) 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) Butter, Sodium Benzoate, Sodium Laurylglucosides Hydroxypropylsulfonate, Styrene/Acrylates Copolymer, Tocopheryl (Vitamin-E), Xanthan Gum.

When Using This Product,

keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor

if rash or irritation occurs.

Keep Out of Reach of Children.

If product is swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

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:

For external use only.

Do Not Use (Do not use)

on damaged or broken skin.

Directions:

• Apply liberally 15 minutes before sun exposure • Reapply • After 80 minutes of swimming or sweating • Immediately after towel drying • At least every 2 hours • 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 of 15 or higher and other sun protection measures including: Sun Protection Measures:

• Limiting time in the sun, especially from 10 am - 2 pm. • Wearing long-sleeve shirts, pants, hats and sunglasses • Children under 6 months: Ask a doctor

Package Labeling:

Active Ingredients

Titanium Dioxide (6.0%)

Zinc Oxide (6.0%)

Other Information:

Protect this product from excessive heat and direct sun.

Inactive Ingredients:

Aloe Barbadensis (Aloe Vera) 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) Butter, Sodium Benzoate, Sodium Laurylglucosides Hydroxypropylsulfonate, Styrene/Acrylates Copolymer, Tocopheryl (Vitamin-E), Xanthan Gum.

When Using This Product, (When using this product,)

keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor (Stop use and ask a doctor)

if rash or irritation occurs.

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

If product is swallowed, get medical help or contact a Poison Control Center right away.


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