Label: ANUBIS BARCELONA PROTECTIVE LINE- ethylhexyl methoxycinnamate, butyl methoxydibenzoylmethane, ethylhexyl salicylate, octocrylene cream
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- NDC Code(s): 83021-686-50
- Packager: ANUBIS COSMETICS SL
- Category: HUMAN OTC DRUG LABEL
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Drug Label Information
Updated November 2, 2022
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- ACTIVE INGREDIENT
- INDICATIONS & USAGE
- KEEP OUT OF REACH OF CHILDREN
- DO NOT USE
- DOSAGE & ADMINISTRATION
- WARNINGS
- INACTIVE INGREDIENT
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INGREDIENTS AND APPEARANCE
ANUBIS BARCELONA PROTECTIVE LINE
ethylhexyl methoxycinnamate, butyl methoxydibenzoylmethane, ethylhexyl salicylate, octocrylene creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83021-686 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 3.5982 g in 50 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 0.425 g in 50 mL CHLORPHENESIN (UNII: I670DAL4SZ) (CHLORPHENESIN - UNII:I670DAL4SZ) CHLORPHENESIN 0.1 g in 50 mL BUTYLENE GLYCOL (UNII: 3XUS85K0RA) (BUTYLENE GLYCOL - UNII:3XUS85K0RA) BUTYLENE GLYCOL 2.5 g in 50 mL PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3) PROPYLENE GLYCOL 2.5 g in 50 mL POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11) (POLY(METHYL METHACRYLATE; 450000 MW) - UNII:Z47NNT4J11) POLY(METHYL METHACRYLATE; 450000 MW) 2.1 g in 50 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 1.8 g in 50 mL WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER 27.55 mL in 50 mL SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE 0.575 g in 50 mL BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) (BUTYLATED HYDROXYTOLUENE - UNII:1P9D0Z171K) BUTYLATED HYDROXYTOLUENE 0.0018 g in 50 mL DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 1.25 g in 50 mL CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) (CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE - UNII:0A5MM307FC) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE 0.025 g in 50 mL C20-22 ALCOHOLS (UNII: O4M0347C6A) (C20-22 ALCOHOLS - UNII:O4M0347C6A) C20-22 ALCOHOLS 0.3375 g in 50 mL FRAGRANCE 13576 (UNII: 5EM498GW35) (FRAGRANCE 13576 - UNII:5EM498GW35) FRAGRANCE 13576 0.3 g in 50 mL CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L) (CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) - UNII:71DD5V995L) CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) 0.075 g in 50 mL TROMETHAMINE (UNII: 023C2WHX2V) (TROMETHAMINE - UNII:023C2WHX2V) TROMETHAMINE 0.22 g in 50 mL BEMOTRIZINOL (UNII: PWZ1720CBH) (BEMOTRIZINOL - UNII:PWZ1720CBH) BEMOTRIZINOL 1.45 g in 50 mL POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ) POLYETHYLENE GLYCOL 400 0.14225 g in 50 mL ASCORBYL PALMITATE (UNII: QN83US2B0N) (ASCORBYL PALMITATE - UNII:QN83US2B0N) ASCORBYL PALMITATE 0.00125 g in 50 mL PHENOXYETHANOL (UNII: HIE492ZZ3T) (PHENOXYETHANOL - UNII:HIE492ZZ3T) PHENOXYETHANOL 0.35 g in 50 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 1.8 g in 50 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 1.8 g in 50 mL LINOLENIC ACID (UNII: 0RBV727H71) (LINOLENIC ACID - UNII:0RBV727H71) LINOLENIC ACID 0.00275 g in 50 mL ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID 0.00025 g in 50 mL TOCOPHEROL (UNII: R0ZB2556P8) (TOCOPHEROL - UNII:R0ZB2556P8) TOCOPHEROL 0.006 g in 50 mL LINOLEIC ACID (UNII: 9KJL21T0QJ) (LINOLEIC ACID - UNII:9KJL21T0QJ) LINOLEIC ACID 0.49725 g in 50 mL GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN 0.005 g in 50 mL Inactive Ingredients Ingredient Name Strength C20-22 ALKYL PHOSPHATE (UNII: L4VKP0Y7RP) 0.4125 g in 50 mL EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) 0.025 g in 50 mL POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) 0.15 g in 50 mL CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) 0.00025 g in 50 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83021-686-50 50 mL in 1 BOTTLE; Type 0: Not a Combination Product 11/02/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M020 11/02/2022 Labeler - ANUBIS COSMETICS SL (468680293) Registrant - GDC OF FLORIDA IMPORTS, INC. (807003988) Establishment Name Address ID/FEI Business Operations ANUBIS COSMETICS SL 468680293 manufacture(83021-686)
