Label: OUTER REEF MINERAL SUNSCREEN SPF 30- titanium dioxide cream
- NDC Code(s): 73691-047-00
- Packager: Coral Reef Park Co., Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 5, 2023
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- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredient
- Uses:
- Warnings:
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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:
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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:
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INGREDIENTS AND APPEARANCE
OUTER REEF MINERAL SUNSCREEN SPF 30
titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73691-047 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 80 mg in 1 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:73691-047-00 100 mL in 1 TUBE; Type 0: Not a Combination Product 03/10/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 03/10/2020 Labeler - Coral Reef Park Co., Inc. (786852207)
