EVEREDEN BOTANICAL FACIAL 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.

----------

Botanical Facial Sunscreen SPF30

Sheer Botanical Facial Sunscreen SPF 30

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: 
o Limit your time in the sun, especially from 10a.m. – 2p.m. 
o Wear long-sleeved shirts, pants, hats, and sunglasses. 

INACTIVE INGREDIENTS

Water (Aqua), Coco-Caprylate/Caprate, Glycerin, Steareth-2, Octyldodecanol, Steareth-21, Propanediol, Cetearyl Alcohol, Polyhydroxystearic Acid, Rosa Centifolia Flower 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 BOTANICAL FACIAL SUNSCREEN SPF 30 
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72113-103
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
WATER (UNII: 059QF0KO0R)  
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
GLYCERIN (UNII: PDC6A3C0OX)  
STEARETH-2 (UNII: V56DFE46J5)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
ROSA CENTIFOLIA FLOWER (UNII: CS4TE8FF7O)  
HELIANTHUS ANNUUS WHOLE (UNII: 17S27ZT6KR)  
SIMMONDSIA CHINENSIS SEED (UNII: D24K2Q1F6H)  
PROPANEDIOL (UNII: 5965N8W85T)  
ZINGIBER OFFICINALE WHOLE (UNII: IN6Q3S3414)  
CETYL GLYCERYL ETHER (UNII: P9FNL3D0MN)  
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
XANTHAN GUM (UNII: TTV12P4NEE)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
STEARETH-21 (UNII: 53J3F32P58)  
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72113-103-031 in 1 CARTON04/19/2021
150 g in 1 BOTTLE, PUMP; 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: f6f551ab-5fb7-9364-e053-6394a90ad83b
Set id: bc977385-fa71-d152-e053-2995a90a4ae2
Version: 2
Effective Time: 20230315
 
Eden Brands Inc