EVERYDAY SUN DEFENSE- zinc oxide cream

Everyday Sun Defense by

Drug Labeling and Warnings

Everyday Sun Defense by is a Otc medication manufactured, distributed, or labeled by Hommerejuvenate, Inc., DERMACEUTICAL LABORATORIES LIMITED LIABILITY COMPANY. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Zinc Oxide 9.4%

Inactive Ingredient

Ammonium Acryloyldimethyltaurate/VP Copolymer, Argania Spinosa Kernel Oil, Bisabolol, Butyrospermum Parkii (Shea Butter) Extract, C12-15 Alkyl Benzoate, C12-20 Glucoside, C14-22 Alcohol, Caprylyl/Capryl Glucoside, Cetearyl Alcohol, Coco Glucoside, Dimethicone, Ethyl Ferulate, Ethylhexylglycerin, Ethylhexylglycerin, Glycerin, Hydroxyethyl Acrylate, Phenoxyethanol, Phospholipids, Polyester-5, Propylene Glycol, Sodium Acryloyl Dimethyl Taurate Copolymer, Sorbitan Oleate Decylglucoside Crosspolymer, Squalane, Tocopheryl Acetate, Triethoxycaprylylsi-lane, Urea, Water

OTC-Ask Doctor

Ask a doctor if rash occurs

OTC-Do Not Use

Do not use on damaged or broken skin

OTC-Keep Out of Reach of Children

Keep out of reach of children. If swallowed, get medical help or contact Poison Control right away

OTC-Purpose

Sunscreen

OTC-Questions

+1) 866-322-3010

OTC-Stop Use

Stop use if rash occurs

OTC-When using

When using this product keep out of eyes
Rinse with water to remove

Indications & Usage Section

High protection against sunburn

WARNINGS

- For external use only
- Do not use on damaged or broken skin
- When using this product, keep out of eyes.
- Rinse with water to remove.
- Stop use and ask a doctor if rash occurs
- Keep out of reach of children. If swallowed, get medical help or contact a Poison Control right away

DOSAGE & ADMINISTRATION

- Apply generously 15 minutes before sun exposure

- Reapply every 2 hours
- Use a water-resistant sunscreen if swimming or sweating

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

EVERYDAY SUN DEFENSE 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83580-010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	9.4 g  in 9.4 g

Inactive Ingredients
Ingredient Name	Strength
ARGAN OIL (UNII: 4V59G5UW9X)
ETHYL FERULATE (UNII: 5B8915UELW)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
SQUALANE (UNII: GW89575KF9)
CAPRYLYL/CAPRYL OLIGOGLUCOSIDE (UNII: E00JL9G9K0)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
WATER (UNII: 059QF0KO0R)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)
DIMETHICONE (UNII: 92RU3N3Y1O)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
COCO GLUCOSIDE (UNII: ICS790225B)
C14-22 ALCOHOLS (UNII: B1K89384RJ)
C12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
OMEGA-3 FATTY ACIDS (UNII: 71M78END5S)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
BENZYL ALCOHOL (UNII: LKG8494WBH)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SHEA BUTTER (UNII: K49155WL9Y)
UREA (UNII: 8W8T17847W)
SORBIC ACID (UNII: X045WJ989B)
POLYESTER-5 (TG-38) (UNII: 2L9351NW8W)
LEVOMENOL (UNII: 24WE03BX2T)
CHLORPHENESIN (UNII: I670DAL4SZ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83580-010-01	60 g in 1 TUBE; Type 0: Not a Combination Product	04/01/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	04/01/2024

Labeler - Hommerejuvenate, Inc. (080651103)

Registrant - Hommerejuvenate, Inc. (080651103)

Establishment
Name	Address	ID/FEI	Business Operations
DERMACEUTICAL LABORATORIES LIMITED LIABILITY COMPANY		078457159	manufacture(83580-010)