outer reef mineral sunscreen spf 30

outer reef mineral sunscreen spf 30
SPL v3
SPL
SPL Set ID 86ee2fdf-8a88-44e6-b12a-36a92360477a
Route
topical
Published
Effective Date 2020-02-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
titanium dioxide (80 mg)
Inactive Ingredients
aloe vera leaf water butyloctyl salicylate green tea leaf medium-chain triglycerides cetostearyl alcohol cetearyl olivate cetyl palmitate watermelon coconut oil carrot dodecane glycerin glyceryl caprylate glyceryl monostearate glyceryl 1-undecylenate helianthus annuus flowering top hydrogenated castor oil hydroxymethyl cellulose magnesium aluminum silicate silicon dioxide sorbitan olivate stearic acid tocopherol tridecyl salicylate

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2020-03-10

Purpose

Sunscreen

Description

Titanium Dioxide 8.00%


Medication Information

Purpose

Sunscreen

Description

Titanium Dioxide 8.00%

Uses:

• Helps prevent sunburn • Higher SPF gives more sunburn protection • Retains SPF after 80 minutes of swimming or sweating • 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 not intended for ingestion.

Directions:

• Apply liberally 15-minutes before sun exposure. • Children under 6-months of age: ask a doctor. • 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 the risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other sun protection measures -Limit time in the sun, especially between 10am and 2pm. -Wear long sleeve shirts, pants, hats and sunglasses.















Sun Protection Measures:

Do Not Use:

• on damaged or broken skin.

Active Ingredient

Titanium Dioxide 8.00%

Package Labeling:

Other Information:

• Protect this product from excessive heat and direct sunlight.

Inactive Ingredients:

*Aloe Barbadensis Leaf (Aloe Vera gel) Juice, Aqua (Deionized Water), Butyloctyl Salicylate, *Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Cetearyl Olivate, Cetyl Palmitate, Citrullus Lanatus (Watermelon) Extract, *Cocos Nucifera (coconut) Oil, Daucus Carota Sativa (Carrot) Extract, Dodecane, *Glycerin, Glyceryl Caprylate, Glyceryl Stearate, Glyceryl Undecylenate, *Helianthus Annuus (Sunflower) Oil, Hydrogenated Castor Oil, Hydroxymethylcellulose, Magnesium Aluminum Silicate, Polyhydroxystearic Acid, Silica, Sorbitan Olivate, Stearic Acid, Tocopherol (Vitamin E), Tridecyl Salicylate. *Denotes certified organic ingredient.

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.


Structured Label Content

Purpose

Sunscreen

Uses:

• Helps prevent sunburn • Higher SPF gives more sunburn protection • Retains SPF after 80 minutes of swimming or sweating • 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 not intended for ingestion.

Directions:

• Apply liberally 15-minutes before sun exposure. • Children under 6-months of age: ask a doctor. • 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 the risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other sun protection measures -Limit time in the sun, especially between 10am and 2pm. -Wear long sleeve shirts, pants, hats and sunglasses.















Sun Protection Measures:

Do Not Use:

• on damaged or broken skin.

Active Ingredient

Titanium Dioxide 8.00%

Package Labeling:

Other Information:

• Protect this product from excessive heat and direct sunlight.

Inactive Ingredients:

*Aloe Barbadensis Leaf (Aloe Vera gel) Juice, Aqua (Deionized Water), Butyloctyl Salicylate, *Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Cetearyl Olivate, Cetyl Palmitate, Citrullus Lanatus (Watermelon) Extract, *Cocos Nucifera (coconut) Oil, Daucus Carota Sativa (Carrot) Extract, Dodecane, *Glycerin, Glyceryl Caprylate, Glyceryl Stearate, Glyceryl Undecylenate, *Helianthus Annuus (Sunflower) Oil, Hydrogenated Castor Oil, Hydroxymethylcellulose, Magnesium Aluminum Silicate, Polyhydroxystearic Acid, Silica, Sorbitan Olivate, Stearic Acid, Tocopherol (Vitamin E), Tridecyl Salicylate. *Denotes certified organic ingredient.

When Using This Product (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. (Keep out of reach of children.)

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


Advanced Ingredient Data


Raw Label Data

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