Label: ANUBIS BARCELONA PROTECTIVE LINE- ethylhexyl methoxycinnamate, butyl methoxydibenzoylmethane, ethylhexyl salicylate, octocrylene cream
- NDC Code(s): 83021-686-50
- Packager: ANUBIS COSMETICS SL
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 September 1, 2023
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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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- PRINCIPAL DISPLAY PANEL
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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 OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 1.8 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 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 CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) 0.00025 g in 50 mL 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 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 03/09/2028 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)
