EVEREDEN FLUID SILK MINERAL SUNSCREEN PRO SPF50- titanium dioxide, zinc oxide lotion

Evereden Fluid Silk Mineral Sunscreen PRO SPF50 by

Drug Labeling and Warnings

Evereden Fluid Silk Mineral Sunscreen PRO SPF50 by is a Otc medication manufactured, distributed, or labeled by Eden Brands Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

STATEMENT OF IDENTITY

ACTIVE INGREDIENTS:

Titanium Dioxide 3.7% Zinc Oxide 14%

PURPOSE:

Sunscreen

USES:

Helps prevent sunburn. 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.

Do not use on damaged or broken skin.

Stop use and ask a doctor if rash occurs.

When using this product keep out of eyes. Rinse with water to remove.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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:

Protect the product in this container from excessive heat and direct sun.

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

INGREDIENTS AND APPEARANCE

EVEREDEN FLUID SILK MINERAL SUNSCREEN PRO SPF50 
titanium dioxide, zinc oxide lotion

Product 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)