EVEREDEN PREMIUM MINERAL SUNSCREEN SPF 30- zinc oxide lotion

Evereden Premium Mineral Sunscreen SPF 30 by

Drug Labeling and Warnings

Evereden Premium Mineral Sunscreen SPF 30 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

SPF30 Premium Mineral Sunscreen Lotion

ACTIVE INGREDIENT

ACTIVE INGREDIENT: Zinc Oxide, 18.8%

PURPOSE

PURPOSE: Sunscreen

INDICATIONS & USAGE

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

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.

INSTRUCTIONS FOR USE

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 INGREDIENT

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

EVEREDEN PREMIUM MINERAL SUNSCREEN SPF 30 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72113-102
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	188 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72113-102-14	1 in 1 CARTON	04/19/2021
1		60 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	04/19/2021

Labeler - Eden Brands Inc (081062339)