EVEREDEN SPF20 PROTECTIVE MINERAL FACE CREAM- zinc oxide cream

Evereden SPF20 Protective Mineral Face Cream by

Drug Labeling and Warnings

Evereden SPF20 Protective Mineral Face Cream 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

ACTIVE INGREDIENT: Zinc Oxide, 11.5%

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 time in the sun, especially from 10am-2pm

-Wear long-sleeved shirts, pants, hats, and sunglasses.

INACTIVE INGREDIENT

INACTIVE INGREDIENTS:

Water (Aqua), Caprylic/Capric Triglyceride, Propanediol, Dimethicone, Glycerin, Butyrospermum Parkii (Shea) Butter, Argania Spinosa Kernel Oil, 1,2-Hexanediol, Tocopheryl Acetate, Polyglyceryl-2 Stearate, Helianthus Annuus (Sunflower) Seed Oil Unsaponifiables, Simmondsia Chinensis (Jojoba) Seed Oil, Glycine Soja (Soybean) Oil, Vegetable Oil, Jojoba Esters, Oryza Sativa (Rice) Germ Extract, Oryza Sativa (Rice) Extract, Hydrogenated Vegetable Oil, Cucumis Sativus (Cucumber) Fruit Extract, Pongamia Pinnata Seed Extract, Euphorbia Cerifera (Candelilla) Wax, Panthenol, Bisabolol, Glyceryl Stearate, Polyhydroxystearic Acid, Stearyl Alcohol, Sclerotium Gum, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Xanthan Gum, Polyglyceryl-3 Diisostearate, Hydroxyacetophenone, Trisodium Ethylenediamine Disuccinate

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

EVEREDEN SPF20 PROTECTIVE MINERAL FACE CREAM 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72113-108
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	115 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CANDELILLA WAX (UNII: WL0328HX19)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
SHEA BUTTER (UNII: K49155WL9Y)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)
XANTHAN GUM (UNII: TTV12P4NEE)
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PROPANEDIOL (UNII: 5965N8W85T)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
ARGAN OIL (UNII: 4V59G5UW9X)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
WATER (UNII: 059QF0KO0R)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
POLYGLYCERYL-2 STEARATE (UNII: 253MC0P0YV)
SUNFLOWER OIL UNSAPONIFIABLES (UNII: T7ZE2WA4MB)
JOJOBA OIL (UNII: 724GKU717M)
SOYBEAN OIL (UNII: 241ATL177A)
CORN OIL (UNII: 8470G57WFM)
JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)
RICE GERM (UNII: 7N2B70SFEZ)
CUCUMBER (UNII: YY7C30VXJT)
PONGAMIA PINNATA SEED (UNII: C2BRV53B1V)
BETASIZOFIRAN (UNII: 2X51AD1X3T)
LEVOMENOL (UNII: 24WE03BX2T)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
PANTHENOL (UNII: WV9CM0O67Z)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72113-108-03	1 in 1 CARTON	03/01/2023
1		50 g in 1 JAR; 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	03/01/2023

Labeler - Eden Brands Inc (081062339)