[de-listing] TIESO RAPIDO PLUS SUNSCREEN + ANTIBACTERIAL 2.7 fl. oz. (80 mL) 69978-0081-1

TIESO RAPIDO PLUS by

Drug Labeling and Warnings

TIESO RAPIDO PLUS by is a Otc medication manufactured, distributed, or labeled by ANDIVA Inc., ATEC CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

TIESO RAPIDO PLUS- homosalate, ethylhexyl salicylate, titanium dioxide, benzalkonium chloride spray 
ANDIVA Inc.

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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[de-listing] TIESO RAPIDO PLUS



SUNSCREEN + ANTIBACTERIAL



2.7 fl. oz. (80 mL)



69978-0081-1

Active ingredients Purposes

Homosalate 5.00 % .......................................... sunscreen
Ethylhexyl Salicylate 4.5% .................................sunscreen
Titanium Dioxide 2.1 % ......................................sunscreen
Benzalkonium Chloride 0.04 % .......................antibacterial

Inactive ingredients Water, Dicaprylyl Carbonate, Alcohol, Cyclomethicone, Phenylbenzimidazole Sulfonic Acid, Lepidium Meyenii Root Extract, Glycerin, 1,2-Hexanediol, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Diethylamino Hydroxybenzoyl Hexyl Benzoate, C13-16 Isoparaffin, PEG-10 Dimethicone, Sodium Chloride, Heptyl Undecylenate, Sodium Hydroxide, Aloe Barbadensis Leaf Extract, Dioscorea Japonica Root Extract, Laminaria Japonica Extract, Ulmus Davidiana Root Extract, Viola Mandshurica Flower Extract, Stearic acid, Aluminum Hydroxide, Butylene Glycol, Disodium EDTA, Fragrance

TIESO RAPIDO PLUS 
homosalate, ethylhexyl salicylate, titanium dioxide, benzalkonium chloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73184-0081
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	4 g  in 80 mL
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.032 g  in 80 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.68 g  in 80 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	3.6 g  in 80 mL

Inactive Ingredients
Ingredient Name	Strength
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
LEPIDIUM MEYENII ROOT (UNII: HP7119212T)
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE (UNII: NMQ347994Z)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
DIOSCOREA JAPONICA ROOT (UNII: I43FCF3356)
VIOLA MANDSHURICA FLOWER (UNII: 46MR945M6X)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ENSULIZOLE (UNII: 9YQ9DI1W42)
C13-16 ISOPARAFFIN (UNII: LED42LZG6O)
DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE (UNII: ANQ870JD20)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
LAMINARIA JAPONICA (UNII: WE98HW412B)
EDETATE DISODIUM (UNII: 7FLD91C86K)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALCOHOL (UNII: 3K9958V90M)
GLYCERIN (UNII: PDC6A3C0OX)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
BEMOTRIZINOL (UNII: PWZ1720CBH)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
HEPTYL UNDECYLENATE (UNII: W77QUB6GXO)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ULMUS DAVIDIANA ROOT (UNII: URQ79U8261)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73184-0081-1	1 in 1 BOX	10/22/2020
1		80 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	10/22/2020	11/30/2020

Labeler - ANDIVA Inc. (695032533)

Establishment
Name	Address	ID/FEI	Business Operations
ATEC CO., LTD.		689276681	manufacture(73184-0081)

Revised: 10/2021

Document Id: ceea01a2-e6f9-9948-e053-2995a90a9e26

34390-5

Set id: b4c2a81b-c0bd-50b6-e053-2a95a90a4d7a

Version: 3

Effective Time: 20211021