Outer Reef: Reef Safe (w/r) Broad Spectrum Spf-30

Outer Reef: Reef Safe (w/r) Broad Spectrum Spf-30
SPL v2
SPL
SPL Set ID 743f3d23-0f5c-4724-9f69-411c109506e1
Route
TOPICAL
Published
Effective Date 2022-05-26
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 Cetearyl Olivate Cetyl Palmitate Watermelon Coconut Oil Carrot Dodecane Glycerin Glyceryl Caprylate Glyceryl Monostearate Helianthus Annuus Flowering Top Hydrogenated Castor Oil Hydroxymethyl Cellulose Magnesium Aluminum Silicate Silicon Dioxide Sorbitan Olivate Stearic Acid Tocopherol Tridecyl Salicylate Xanthan Gum Triethoxycaprylylsilane

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-06-06

Description

Titanium Dioxide 8.00%

Purpose

Sunscreen


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 ), decreases the risk of skin cancer and early skin aging caused by the sun. directions
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:
  • Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscren with broad spectrum SPF of 15 or higher and other sun protection measures Sun Protection Measures:

-after 80 minutes of swimming or sweating

-immediately after towel drying

-at least every 2 hours

-Limit time in the sun, especially between 10am and 2pm.

-Wear long sleeve shirts, pants, hats and sunglasses.

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 Sinenesis (Green Tea) Extract, Caprylic/Capric Triglyceride, 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, xanthan gum, triethoxycaprylylsilane.

*Denotes certified organic ingredient.

Comments & Suggestions:
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 poisin control center immediately.

Stop Use and Consult Physician 

if irritation or rash develops.


Structured Label Content

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 ), decreases the risk of skin cancer and early skin aging caused by the sun. directions
Purpose

Sunscreen

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:
  • Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscren with broad spectrum SPF of 15 or higher and other sun protection measures Sun Protection Measures:

-after 80 minutes of swimming or sweating

-immediately after towel drying

-at least every 2 hours

-Limit time in the sun, especially between 10am and 2pm.

-Wear long sleeve shirts, pants, hats and sunglasses.

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 Sinenesis (Green Tea) Extract, Caprylic/Capric Triglyceride, 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, xanthan gum, triethoxycaprylylsilane.

*Denotes certified organic ingredient.

Comments & Suggestions:
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 poisin 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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