ESSENTIAL SUNSCREEN SPF50 lotion

Essential Sunscreen SPF50 by

Drug Labeling and Warnings

Essential Sunscreen SPF50 by is a Otc medication manufactured, distributed, or labeled by Milbar Laboratories, Milbar Labs, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DOSAGE & ADMINISTRATION

WARNINGS

INACTIVE INGREDIENT

INDICATIONS & USAGE

PURPOSE

Principal Display

INGREDIENTS AND APPEARANCE

ESSENTIAL SUNSCREEN SPF50 
essential sunscreen spf50 lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57577-571
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	11.508 g  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	8.22 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
XANTHAN GUM (UNII: TTV12P4NEE)
SQUALANE (UNII: GW89575KF9)
ISODODECANE (UNII: A8289P68Y2)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
WATER (UNII: 059QF0KO0R)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
PEG-40 MONOSTEARATE (UNII: ECU18C66Q7)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
DIMETHICONE CROSSPOLYMER (UNII: UF7620L1W6)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PEG-10 DIMETHICONE (220 CST) (UNII: 287GF3Y3WC)

Product Characteristics
Color	white (Thick Lotion)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57577-571-01	100 mL in 1 TUBE; Type 0: Not a Combination Product	07/29/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	07/29/2024

Labeler - Milbar Laboratories (055359970)

Establishment
Name	Address	ID/FEI	Business Operations
Milbar Labs, Inc.		195556790	manufacture(57577-571)