Label: ANUBIS BARCELONA SPA LINE (oryza sativa- rice starch, perlite, palmitic acid cream
- NDC Code(s): 83021-305-50
- 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
- DO NOT USE
- DOSAGE & ADMINISTRATION
- WARNINGS
- INACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ANUBIS BARCELONA SPA LINE
oryza sativa (rice) starch, perlite, palmitic acid creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83021-305 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FRAGRANCE 13576 (UNII: 5EM498GW35) (FRAGRANCE 13576 - UNII:5EM498GW35) FRAGRANCE 13576 0.15 g in 50 mL GRAPE SEED OIL (UNII: 930MLC8XGG) (GRAPE SEED OIL - UNII:930MLC8XGG) GRAPE SEED OIL 0.25 g in 50 mL GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) (GLYCERYL MONOSTEARATE - UNII:230OU9XXE4) GLYCERYL MONOSTEARATE 3.5 g in 50 mL LINALOOL, (+/-)- (UNII: D81QY6I88E) (LINALOOL, (+/-)- - UNII:D81QY6I88E) LINALOOL, (+/-)- 0.0114 g in 50 mL PHENOXYETHANOL (UNII: HIE492ZZ3T) (PHENOXYETHANOL - UNII:HIE492ZZ3T) PHENOXYETHANOL 0.45 g in 50 mL PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3) PROPYLENE GLYCOL 1.5 g in 50 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 0.25 g in 50 mL PALMITIC ACID (UNII: 2V16EO95H1) (PALMITIC ACID - UNII:2V16EO95H1) PALMITIC ACID 1 g in 50 mL BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) (BUTYLATED HYDROXYTOLUENE - UNII:1P9D0Z171K) BUTYLATED HYDROXYTOLUENE 0.25 g in 50 mL STARCH, RICE (UNII: 4DGK8B7I3S) (STARCH, RICE - UNII:4DGK8B7I3S) STARCH, RICE 5.5 g in 50 mL ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 4.752 mL in 50 mL C12-20 ACID PEG-8 ESTER (UNII: 9M7A3K4339) (C12-20 ACID PEG-8 ESTER - UNII:9M7A3K4339) C12-20 ACID PEG-8 ESTER 1 g in 50 mL TROLAMINE (UNII: 9O3K93S3TK) (TROLAMINE - UNII:9O3K93S3TK) TROLAMINE 0.25 g in 50 mL ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B) (ISOMETHYL-.ALPHA.-IONONE - UNII:9XP4LC555B) ISOMETHYL-.ALPHA.-IONONE 0.00639 g in 50 mL HYDROXYACETOPHENONE (UNII: G1L3HT4CMH) (HYDROXYACETOPHENONE - UNII:G1L3HT4CMH) HYDROXYACETOPHENONE 0.25 g in 50 mL PERLITE (UNII: 0SG101ZGK9) (PERLITE - UNII:0SG101ZGK9) PERLITE 4 g in 50 mL GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN 0.0115 g in 50 mL ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) (ETHYLHEXYLGLYCERIN - UNII:147D247K3P) ETHYLHEXYLGLYCERIN 0.05 g in 50 mL .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K) (.BETA.-CITRONELLOL, (R)- - UNII:P01OUT964K) .BETA.-CITRONELLOL, (R)- 0.012 g in 50 mL WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER 25.04945 g in 50 mL STEARIC ACID (UNII: 4ELV7Z65AP) (STEARIC ACID - UNII:4ELV7Z65AP) STEARIC ACID 1 g in 50 mL CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25) (CETEARYL ETHYLHEXANOATE - UNII:9M64UO4C25) CETEARYL ETHYLHEXANOATE 0.75 g in 50 mL Inactive Ingredients Ingredient Name Strength LIMONENE, (+)- (UNII: GFD7C86Q1W) 0.00726 g in 50 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83021-305-50 50 mL in 1 TUBE; Type 0: Not a Combination Product 10/14/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M016 10/14/2022 10/13/2027 Labeler - ANUBIS COSMETICS SL (468680293) Registrant - GDC OF FLORIDA IMPORTS, INC. (807003988) Establishment Name Address ID/FEI Business Operations ANUBIS COSMETICS SL 468680293 manufacture(83021-305)
