Outer Reef Reef Safe (wr) Broad Spectrum Spf 30 Cream
FDA Label NDC 73691-296

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Coral Reef Park Co., Inc. for the product Outer Reef Reef Safe (wr) Broad Spectrum Spf 30 (NDC 73691-296). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses:, warnings:, do not use:, when using this product, stop use and consult physician, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Titanium Dioxide 8.00%

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.

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 poisin control center immediately.

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

    • Sun Protection Measures: 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

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

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

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.

Package Labeling:

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* Please review the disclaimer below.