OUTER REEF MINERAL SUNSCREEN SPF 30- titanium dioxide cream 
Coral Reef Park Co., Inc.

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OUTER REEF MINERAL SUNSCREEN SPF 30

Drug Facts

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 poison 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 • 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:

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.

Package Labeling:

Label

OUTER REEF MINERAL SUNSCREEN SPF 30 
titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73691-047
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE80 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
WATER (UNII: 059QF0KO0R)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETEARYL OLIVATE (UNII: 58B69Q84JO)  
CETYL PALMITATE (UNII: 5ZA2S6B08X)  
WATERMELON (UNII: 231473QB6R)  
COCONUT OIL (UNII: Q9L0O73W7L)  
CARROT (UNII: L56Z1JK48B)  
DODECANE (UNII: 11A386X1QH)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
GLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544)  
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)  
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
HYDROXYMETHYL CELLULOSE (UNII: 273FM27VK1)  
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SORBITAN OLIVATE (UNII: MDL271E3GR)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TOCOPHEROL (UNII: R0ZB2556P8)  
TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73691-047-00100 mL in 1 TUBE; Type 0: Not a Combination Product03/10/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02003/10/2020
Labeler - Coral Reef Park Co., Inc. (786852207)

Revised: 11/2023
Document Id: 09752095-fe1c-c6de-e063-6294a90a88dd
Set id: 86ee2fdf-8a88-44e6-b12a-36a92360477a
Version: 2
Effective Time: 20231105
 
Coral Reef Park Co., Inc.