Label: EVEREDEN FLUID SILK MINERAL SUNSCREEN PRO SPF50- titanium dioxide, zinc oxide lotion
- NDC Code(s): 72113-110-14
- Packager: Eden Brands Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 27, 2025
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- STATEMENT OF IDENTITY
- ACTIVE INGREDIENTS:
- PURPOSE:
- USES:
- WARNINGS:
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DIRECTIONS:
• Shake well before use.
• Apply liberally 15 minutes before sun exposure and as needed.
• Reapply: • After 40 minutes of swimming or sweating • Immediately after towel drying • At least every 2 hours
• Children under 6 months of age: ask a doctor. •
Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
• Limit your time in the sun, especially from 10 a.m. – 2 p.m.
• Wear long-sleeved shirts, pants, hats, and sunglasses.
- OTHER INFORMATION:
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INACTIVE INGREDIENTS:
Water (Aqua), Cetyl Ethylhexanoate, Undecane, Caprylic/Capric Triglyceride, C13-15 Alkane, Dicaprylyl Ether, Tridecane, Argania Spinosa Kernel Oil, Propanediol, Tocopheryl Acetate, 1,2-Hexanediol, Polyglyceryl-6 Polyricinoleate, Polyhydroxystearic Acid, Silica, Stearyl Citrate, Trioctyldodecyl Citrate, Aluminum Hydroxide, Stearic Acid, Sodium Chloride, Carthamus Tinctorius (Safflower) Oleosomes, Cucumis Sativus (Cucumber) Fruit Extract, Dextrin Palmitate, Maris Limus Extract, Magnolia Officinalis Bark Extract, Thermus Thermophillus Ferment, Bisabolol, Aloe Barbadensis Leaf Juice, Cocos Nucifera (Coconut) Fruit Juice, Cocos Nucifera (Coconut) Oil, Helianthus Annuus (Sunflower) Seed Oil, Helianthus Annuus (Sunflower) Seed Oil Unsaponifiables, Persea Gratissima (Avocado) Oil, Rosa Rubiginosa Seed Oil, Vitis Vinifera (Grape) Seed Oil, Methyl Diisopropyl Propionamide, Pongamia Pinnata Seed Extract, Xanthan Gum, Cetyl Glyceryl Ether, Sodium Phytate, Glycerin, Pongamia Glabra Seed Oil, Phenylpropanol, Caprylyl Glycol, Potassium Sorbate, Hydroxyacetophenone, Dunaliella Salina Extract, Haematococcus Pluvialis Extract
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
EVEREDEN FLUID SILK MINERAL SUNSCREEN PRO SPF50
titanium dioxide, zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72113-110 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 140 mg in 1 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 37 mg in 1 g Inactive Ingredients Ingredient Name Strength PROPANEDIOL (UNII: 5965N8W85T) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309) ROSA RUBIGINOSA SEED OIL (UNII: 8M1P49MWAP) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) PHENYLPROPANOL (UNII: 0F897O3O4M) WATER (UNII: 059QF0KO0R) UNDECANE (UNII: JV0QT00NUE) DICAPRYLYL ETHER (UNII: 77JZM5516Z) ARGANIA SPINOSA KERNEL OIL (UNII: 4V59G5UW9X) CETYL ETHYLHEXANOATE (UNII: 134647WMX4) STEARIC ACID (UNII: 4ELV7Z65AP) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) BISABOLOL (UNII: 24WE03BX2T) HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL (UNII: 3W1JG795YI) SODIUM CHLORIDE (UNII: 451W47IQ8X) DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3) HYDROXYACETOPHENONE (UNII: G1L3HT4CMH) DUNALIELLA SALINA (UNII: F4O1DKI9A6) C13-15 ALKANE (UNII: 114P5I43UJ) TRIDECANE (UNII: A3LZF0L939) STEARYL CITRATE (UNII: YWW937R1QR) TRIOCTYLDODECYL CITRATE (UNII: 35X8CT063R) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) THERMUS THERMOPHILUS LYSATE (UNII: 775R692494) COCOS NUCIFERA (COCONUT) OIL (UNII: Q9L0O73W7L) CUCUMBER (UNII: YY7C30VXJT) ALOE BARBADENSIS LEAF JUICE (UNII: ZY81Z83H0X) VITIS VINIFERA (GRAPE) SEED OIL (UNII: 930MLC8XGG) PONGAMIA GLABRA SEED OIL (UNII: 62160PU6FJ) MAGNOLIA OFFICINALIS BARK (UNII: 5M609NV974) COCOS NUCIFERA (COCONUT) FRUIT JUICE (UNII: AMN6S4M09G) HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL UNSAPONIFIABLES (UNII: T7ZE2WA4MB) PERSEA GRATISSIMA (AVOCADO) OIL (UNII: 6VNO72PFC1) METHYL DIISOPROPYL PROPIONAMIDE (UNII: 6QOP5A9489) PONGAMIA PINNATA SEED (UNII: C2BRV53B1V) XANTHAN GUM (UNII: TTV12P4NEE) GLYCERIN (UNII: PDC6A3C0OX) CETYL GLYCERYL ETHER (UNII: P9FNL3D0MN) SODIUM PHYTATE (UNII: 88496G1ERL) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) POLYGLYCERYL-6 POLYRICINOLEATE (UNII: YPM0ZOC2HR) HAEMATOCOCCUS PLUVIALIS (UNII: 31T0FF0472) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72113-110-14 1 in 1 CARTON 12/18/2024 1 60 g in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 12/18/2024 Labeler - Eden Brands Inc. (081062339)


