EVEREDEN PREMIUM MINERAL SUNSCREEN SPF 30- zinc oxide lotion 
Eden Brands Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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SPF30 Premium Mineral Sunscreen Lotion

SPF30 Premium Mineral Sunscreen Lotion

Primary

ACTIVE INGREDIENT: Zinc Oxide, 18.8%

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:

- Apply liberally 15 minutes before sun exposure

- Reapply at least every 2 hours

- Use a water resistant sunscreen if swimming or sweating

- 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 10am-2pm

-wear long-sleeved shirts, pants, hats, and sungalsses.

INACTIVE INGREDIENTS:

Water (Aqua), Coco-Caprylate/Caprate, Glycerin, Steareth-2, Octyldodecanol, Steareth-21, Propanediol, Cetearyl Alcohol, Polyhydroxystearic Acid, Cucumis Sativus (Cucumber) Fruit Extract, Zingiber Officinale (Ginger) Root Extract, Helianthus Annuus (Sunflower) Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Bisabolol, Cetyl Glyceryl Ether, Sodium Stearoyl Glutamate, Xanthan Gum, Tetrasodium Glutamate Diacetate, Caprylhydroxamic Acid, Sodium Hydroxide

Secondary

EVEREDEN PREMIUM MINERAL SUNSCREEN SPF 30 
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72113-102
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE188 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
OCTYLDODECANOL (UNII: 461N1O614Y)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
CUCUMIS SATIVUS WHOLE (UNII: 50560UL2YV)  
ZINGIBER OFFICINALE WHOLE (UNII: IN6Q3S3414)  
XANTHAN GUM (UNII: TTV12P4NEE)  
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
WATER (UNII: 059QF0KO0R)  
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
STEARETH-2 (UNII: V56DFE46J5)  
STEARETH-21 (UNII: 53J3F32P58)  
PROPANEDIOL (UNII: 5965N8W85T)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
GLYCERIN (UNII: PDC6A3C0OX)  
HELIANTHUS ANNUUS WHOLE (UNII: 17S27ZT6KR)  
SIMMONDSIA CHINENSIS SEED (UNII: D24K2Q1F6H)  
CETYL GLYCERYL ETHER (UNII: P9FNL3D0MN)  
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72113-102-141 in 1 CARTON04/19/2021
160 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35204/19/2021
Labeler - Eden Brands Inc (081062339)

Revised: 3/2023
Document Id: f6f54ce2-7dd4-fb15-e053-6294a90a5dc6
Set id: bba219a4-de83-76fd-e053-2995a90a2d69
Version: 2
Effective Time: 20230315
 
Eden Brands Inc