EVEREDEN SPF50 PREMIUM MINERAL SUNSCREEN- zinc oxide, titanium dioxide lotion

Evereden SPF50 Premium Mineral Sunscreen by

Drug Labeling and Warnings

Evereden SPF50 Premium Mineral Sunscreen 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 INGREDIENT

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.

WARNINGS

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.

INACTIVE INGREDIENTS

Water (Aqua), Caprylic/Capric Triglyceride, Dicaprylyl Ether, C13-15 Alkane, Propanediol, Argania Spinosa Kernel Oil, 1,2-Hexanediol, Stearyl Citrate, Trioctyldodecyl Citrate, Tocopheryl Acetate, Sorbitan Sesquioleate, Polyglyceryl-10 Mono/Dioleate, Silica, Polyhydroxystearic Acid, Carthamus Tinctorius (Safflower) Oleosomes, Stearic Acid, Aluminum Hydroxide, Hydroxyacetophenone, Butyrospermum Parkii (Shea) Butter, Cucumis Sativus (Cucumber) Fruit Extract, Caesalpinia Spinosa Gum, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Vitis Vinifera (Grape) Seed Oil, Rosa Rubiginosa Seed Oil, Pongamia Pinnata Seed Extract, Persea Gratissima (Avocado) Oil, Helianthus Annuus (Sunflower) Seed Oil Unsaponifiables, Helianthus Annuus (Sunflower) Seed Oil, Cocos Nucifera (Coconut) Oil, Bisbolol, Sodium Phytate, Phenylpropanol, Caprylyl Glycol

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

EVEREDEN SPF50 PREMIUM MINERAL SUNSCREEN 
zinc oxide, titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72113-107
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	14 g  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	3.7 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
SUNFLOWER OIL (UNII: 3W1JG795YI)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
POLYGLYCERYL-10 DIOLEATE (UNII: 598RES7AXX)
PONGAMIA PINNATA SEED (UNII: C2BRV53B1V)
AVOCADO OIL (UNII: 6VNO72PFC1)
CUCUMBER (UNII: YY7C30VXJT)
CAESALPINIA SPINOSA RESIN (UNII: WL3883U2PO)
ROSA RUBIGINOSA SEED OIL (UNII: 8M1P49MWAP)
GRAPE SEED OIL (UNII: 930MLC8XGG)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
SHEA BUTTER (UNII: K49155WL9Y)
PHYTATE SODIUM (UNII: 88496G1ERL)
PHENYLPROPANOL (UNII: 0F897O3O4M)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
DICAPRYLYL ETHER (UNII: 77JZM5516Z)
ARGAN OIL (UNII: 4V59G5UW9X)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
C13-15 ALKANE (UNII: 114P5I43UJ)
MONOSTEARYL CITRATE (UNII: YWW937R1QR)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)
COCONUT OIL (UNII: Q9L0O73W7L)
LEVOMENOL (UNII: 24WE03BX2T)
WATER (UNII: 059QF0KO0R)
PROPANEDIOL (UNII: 5965N8W85T)
TRIOCTYLDODECYL CITRATE (UNII: 35X8CT063R)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72113-107-14	1 in 1 CARTON	01/18/2022
1		60 mL in 1 BOTTLE, DISPENSING; 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	01/18/2022

Labeler - Eden Brands Inc (081062339)