EB EPICURUS SPF 50 THE SUNSCREEN- avobenzone, octocrylene, octinoxate lotion

EB Epicurus SPF 50 The Sunscreen by

Drug Labeling and Warnings

EB Epicurus SPF 50 The Sunscreen by is a Otc medication manufactured, distributed, or labeled by BIOCROWN BIOTECHNOLOGY CO., LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Avobenzone 3%

Octocrylene 1.5%

Octinoxate 3%

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

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 this product is swallowed get medical help or contact a Poison Control Centre right away.

Directions

Apply liberally 15 minutes before sun exposure
Reapply:

• after 80 minutes of swimming or sweating
• immediately after towel drying
• at least every 2 hours

Sun Protection Measures

• Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with a Broad Spectrun SPF value of 15 of higher and other sun protection measure including:
• limit time in the sun, especially from 10am-2pm
• wear long-sleeve shirts, pants, hats and sunglasses
• children under 6 months of age: Ask a doctor

Other information

Protect this product from excessive heat and direct sun

Inactive ingredients

Water, Phospholipids, Butylene Glycol, Alcohol, Polymethylsilsesquioxane, Cyclopentasiloxane, Squalane, Sodium Polyacrylate, Caprylic/Capric Triglycerides, Mineral Oil, Tri-PPG-3 Myristyl Ether Citrate, Sorbitan Laurate, Trideceth-6, Dimethicone, Cyclotetrasiloxane, Triisostearin, Decyl Glucoside, tocopheryl acetate, Chlorphenesin, Glycerin, Vaccinium Macrocarpon (Cranberry) Fruit Extract, Cucumis Sativus (Cucumber) Fruit Extract, Diospyros Kaki Fruit Extract, Sodium Lactate, Aloe Barbadensis Leaf Juice, Phenoxyethanol, Caprylyl Glycol, Sodium Benzoate, Potassium Sorbate, Carbomer, aminomethyl propanol.

Questions?

service@epicurusbeaute.com

Package Labeling:

INGREDIENTS AND APPEARANCE

EB EPICURUS SPF 50 THE SUNSCREEN 
avobenzone, octocrylene, octinoxate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81901-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	30 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	15 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ALCOHOL (UNII: 3K9958V90M)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
MINERAL OIL (UNII: T5L8T28FGP)
SODIUM BENZOATE (UNII: OJ245FE5EU)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F)
2,4,6,8-TETRAMETHYLTETRAPHENYLCYCLOTETRASILOXANE, (2.ALPHA.,4.ALPHA.,6.BETA.,8.BETA.)- (UNII: 2F641J843Q)
PHOSPHATIDYLCHOLINE, SOYBEAN (UNII: 1T6N4D9YV6)
PPG-3 MYRISTYL ETHER (UNII: 7913J43WZ5)
CYCLOMETHICONE 4 (UNII: CZ227117JE)
WATER (UNII: 059QF0KO0R)
SQUALANE (UNII: GW89575KF9)
PPG-1 TRIDECETH-6 (UNII: 1K7417JX6Q)
DIMETHICONE (UNII: 92RU3N3Y1O)
TRIISOSTEARIN (UNII: 71503RH8KG)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
CHLORPHENESIN (UNII: I670DAL4SZ)
SODIUM LACTATE (UNII: TU7HW0W0QT)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
GLYCERIN (UNII: PDC6A3C0OX)
DIOSPYROS KAKI LEAF (UNII: Q71GF9OBNO)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SORBITAN MONOLAURATE (UNII: 6W9PS8B71J)
CRANBERRY JUICE (UNII: Y74M3X3345)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
CUCUMBER (UNII: YY7C30VXJT)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM ACRYLATE (UNII: 7C98FKB43H)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81901-001-35	35 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	06/01/2021

Labeler - BIOCROWN BIOTECHNOLOGY CO., LTD (656300956)

Establishment
Name	Address	ID/FEI	Business Operations
BIOCROWN BIOTECHNOLOGY CO., LTD		656300956	manufacture(81901-001)