ANUBISMED- spf 50 broad spectrum protection fluid emulsion cream 
ANUBIS COSMETICS SL

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.

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AnubisMed 50+ Protection Fluid Active Ingredients

AnubisMed 50+ Protection Fluid Indications and Usage

AnubisMed 50+ Protection Fluid Do Not Use Section

Keep out of reach

how to use

warnings

ingredients

Purpose

Package Label. Principal Display Panel

ANUBISMED 
spf 50 broad spectrum protection fluid emulsion cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83021-551
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) (CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE - UNII:0A5MM307FC) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0.025 g  in 50 mL
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN0.005 g  in 50 mL
LINOLENIC ACID (UNII: 0RBV727H71) (LINOLENIC ACID - UNII:0RBV727H71) LINOLENIC ACID0.00275 g  in 50 mL
TROMETHAMINE (UNII: 023C2WHX2V) (TROMETHAMINE - UNII:023C2WHX2V) TROMETHAMINE0.22 g  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1.8 g  in 50 mL
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) (BUTYLATED HYDROXYTOLUENE - UNII:1P9D0Z171K) BUTYLATED HYDROXYTOLUENE0.0018 g  in 50 mL
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3) PROPYLENE GLYCOL2.5 g  in 50 mL
WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER27.55 mL  in 50 mL
FRAGRANCE 13576 (UNII: 5EM498GW35) (FRAGRANCE 13576 - UNII:5EM498GW35) FRAGRANCE 135760.3 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.-TOCOPHEROL0.006 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) AVOBENZONE1.8 g  in 50 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.425 g  in 50 mL
PHENOXYETHANOL (UNII: HIE492ZZ3T) (PHENOXYETHANOL - UNII:HIE492ZZ3T) PHENOXYETHANOL0.35 g  in 50 mL
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ) POLYETHYLENE GLYCOL 4000.14225 g  in 50 mL
LINOLEIC ACID (UNII: 9KJL21T0QJ) (LINOLEIC ACID - UNII:9KJL21T0QJ) LINOLEIC ACID0.49725 g  in 50 mL
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE0.575 g  in 50 mL
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) ANHYDROUS CITRIC ACID0.00025 g  in 50 mL
ASCORBYL PALMITATE (UNII: QN83US2B0N) (ASCORBYL PALMITATE - UNII:QN83US2B0N) ASCORBYL PALMITATE0.00125 g  in 50 mL
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID0.00025 g  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE1.8 g  in 50 mL
BEMOTRIZINOL (UNII: PWZ1720CBH) (BEMOTRIZINOL - UNII:PWZ1720CBH) BEMOTRIZINOL1.45 g  in 50 mL
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE1.25 g  in 50 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3.5982 g  in 50 mL
BUTYLENE GLYCOL (UNII: 3XUS85K0RA) (BUTYLENE GLYCOL - UNII:3XUS85K0RA) BUTYLENE GLYCOL2.5 g  in 50 mL
C20-22 ALCOHOLS (UNII: O4M0347C6A) (C20-22 ALCOHOLS - UNII:O4M0347C6A) C20-22 ALCOHOLS0.3375 g  in 50 mL
CHLORPHENESIN (UNII: I670DAL4SZ) (CHLORPHENESIN - UNII:I670DAL4SZ) CHLORPHENESIN0.1 g  in 50 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83021-551-5050 mL in 1 BOTTLE; Type 0: Not a Combination Product10/15/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM02010/15/202204/29/2027
Labeler - ANUBIS COSMETICS SL (468680293)
Registrant - GDC OF FLORIDA IMPORTS, INC. (807003988)
Establishment
NameAddressID/FEIBusiness Operations
ANUBIS COSMETICS SL468680293manufacture(83021-551)

Revised: 9/2023
Document Id: 049fca13-6920-d895-e063-6294a90a42da
Set id: e99d92c4-8768-9c0a-e053-2a95a90a609e
Version: 2
Effective Time: 20230905
 
ANUBIS COSMETICS SL