Label: ANUBISMED- spf 50 broad spectrum protection fluid emulsion cream
- NDC Code(s): 83021-551-50
- 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 5, 2023
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- ACTIVE INGREDIENT
- INDICATIONS & USAGE
- DO NOT USE
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- WARNINGS
- INACTIVE INGREDIENT
- PURPOSE
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ANUBISMED
spf 50 broad spectrum protection fluid emulsion creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83021-551 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) (CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE - UNII:0A5MM307FC) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE 0.025 g in 50 mL GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN 0.005 g in 50 mL LINOLENIC ACID (UNII: 0RBV727H71) (LINOLENIC ACID - UNII:0RBV727H71) LINOLENIC ACID 0.00275 g in 50 mL TROMETHAMINE (UNII: 023C2WHX2V) (TROMETHAMINE - UNII:023C2WHX2V) TROMETHAMINE 0.22 g in 50 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 1.8 g in 50 mL BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) (BUTYLATED HYDROXYTOLUENE - UNII:1P9D0Z171K) BUTYLATED HYDROXYTOLUENE 0.0018 g in 50 mL PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3) PROPYLENE GLYCOL 2.5 g in 50 mL WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER 27.55 mL 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 .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1) .ALPHA.-TOCOPHEROL 0.006 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 AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 1.8 g in 50 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 0.425 g in 50 mL PHENOXYETHANOL (UNII: HIE492ZZ3T) (PHENOXYETHANOL - UNII:HIE492ZZ3T) PHENOXYETHANOL 0.35 g in 50 mL POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ) POLYETHYLENE GLYCOL 400 0.14225 g in 50 mL LINOLEIC ACID (UNII: 9KJL21T0QJ) (LINOLEIC ACID - UNII:9KJL21T0QJ) LINOLEIC ACID 0.49725 g in 50 mL SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE 0.575 g in 50 mL ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) ANHYDROUS CITRIC ACID 0.00025 g in 50 mL ASCORBYL PALMITATE (UNII: QN83US2B0N) (ASCORBYL PALMITATE - UNII:QN83US2B0N) ASCORBYL PALMITATE 0.00125 g in 50 mL ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID 0.00025 g in 50 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 1.8 g in 50 mL BEMOTRIZINOL (UNII: PWZ1720CBH) (BEMOTRIZINOL - UNII:PWZ1720CBH) BEMOTRIZINOL 1.45 g in 50 mL DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 1.25 g in 50 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 3.5982 g in 50 mL BUTYLENE GLYCOL (UNII: 3XUS85K0RA) (BUTYLENE GLYCOL - UNII:3XUS85K0RA) BUTYLENE GLYCOL 2.5 g in 50 mL C20-22 ALCOHOLS (UNII: O4M0347C6A) (C20-22 ALCOHOLS - UNII:O4M0347C6A) C20-22 ALCOHOLS 0.3375 g in 50 mL CHLORPHENESIN (UNII: I670DAL4SZ) (CHLORPHENESIN - UNII:I670DAL4SZ) CHLORPHENESIN 0.1 g in 50 mL Inactive Ingredients Ingredient Name Strength POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) 0.15 g in 50 mL EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) 0.025 g in 50 mL C20-22 ALKYL PHOSPHATE (UNII: L4VKP0Y7RP) 0.4125 g in 50 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83021-551-50 50 mL in 1 BOTTLE; Type 0: Not a Combination Product 10/15/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M020 10/15/2022 04/29/2027 Labeler - ANUBIS COSMETICS SL (468680293) Registrant - GDC OF FLORIDA IMPORTS, INC. (807003988) Establishment Name Address ID/FEI Business Operations ANUBIS COSMETICS SL 468680293 manufacture(83021-551)
