ANUBIS BARCELONA TOTAL HYDRATING- betaine, glycerin, polysorbate 20 lotion

Anubis Barcelona Total Hydrating by

Drug Labeling and Warnings

Anubis Barcelona Total Hydrating by is a Otc medication manufactured, distributed, or labeled by ANUBIS COSMETICS SL, GDC OF FLORIDA IMPORTS, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

INDICATIONS & USAGE

DO NOT USE

KEEP OUT OF REACH OF CHILDREN

DOSAGE & ADMINISTRATION

WARNINGS

INACTIVE INGREDIENT

PURPOSE

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ANUBIS BARCELONA TOTAL HYDRATING 
betaine, glycerin, polysorbate 20 lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83021-692
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BETAINE (UNII: 3SCV180C9W) (BETAINE - UNII:3SCV180C9W)	BETAINE	5 g  in 250 mL
FRAGRANCE 13576 (UNII: 5EM498GW35) (FRAGRANCE 13576 - UNII:5EM498GW35)	FRAGRANCE 13576	0.125 g  in 250 mL
FD&C BLUE NO. 1 (UNII: H3R47K3TBD) (FD&C BLUE NO. 1 - UNII:H3R47K3TBD)	FD&C BLUE NO. 1	0.00025 g  in 250 mL
BENZOIC ACID (UNII: 8SKN0B0MIM) (BENZOIC ACID - UNII:8SKN0B0MIM)	BENZOIC ACID	1.75 g  in 250 mL
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	5 g  in 250 mL
PHENOXYETHANOL (UNII: HIE492ZZ3T) (PHENOXYETHANOL - UNII:HIE492ZZ3T)	PHENOXYETHANOL	2.25 g  in 250 mL
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) (ETHYLHEXYLGLYCERIN - UNII:147D247K3P)	ETHYLHEXYLGLYCERIN	0.125 g  in 250 mL
POLYSORBATE 20 (UNII: 7T1F30V5YH) (POLYSORBATE 20 - UNII:7T1F30V5YH)	POLYSORBATE 20	2.75 g  in 250 mL
WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R)	WATER	232.139 mL  in 250 mL
IMIDUREA (UNII: M629807ATL) (IMIDUREA - UNII:M629807ATL)	IMIDUREA	0.75 g  in 250 mL

Inactive Ingredients
Ingredient Name	Strength
DEHYDROACETIC ACID (UNII: 2KAG279R6R)	0.1 g  in 250 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83021-692-01	250 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	10/13/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M016	10/13/2022	09/12/2027

Labeler - ANUBIS COSMETICS SL (468680293)

Registrant - GDC OF FLORIDA IMPORTS, INC. (807003988)

Establishment
Name	Address	ID/FEI	Business Operations
ANUBIS COSMETICS SL		468680293	manufacture(83021-692)