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

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SPF50 Premium Mineral Sunscreen Lotion

Primary

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

Secondary

EVEREDEN SPF50 PREMIUM MINERAL SUNSCREEN 
zinc oxide, titanium dioxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72113-107
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE14 g  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE3.7 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72113-107-141 in 1 CARTON01/18/2022
160 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02001/18/2022
Labeler - Eden Brands Inc (081062339)

Revised: 10/2023
Document Id: 082bf765-c945-3716-e063-6294a90a34dc
Set id: dcedc364-3cee-d30a-e053-2995a90a7d78
Version: 3
Effective Time: 20231016
 
Eden Brands Inc