Label: EB EPICURUS SPF 50 THE SUNSCREEN- avobenzone, octocrylene, octinoxate lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 81901-001-35 - Packager: BIOCROWN BIOTECHNOLOGY CO., LTD
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated June 2, 2021
If you are a consumer or patient please visit this version.
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- Drug Facts
- Active ingredients
- Uses
- Warnings
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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
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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.
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INGREDIENTS AND APPEARANCE
EB EPICURUS SPF 50 THE SUNSCREEN
avobenzone, octocrylene, octinoxate lotionProduct 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)
