[de-listing] TIESO SOL UV PROTECTOR

TIESO SOL UV PROTECTOR by

Drug Labeling and Warnings

TIESO SOL UV PROTECTOR 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 SOL UV PROTECTOR- ethylhexyl methoxycinnamate, ethylhexyl salicylate, titanium dioxide cream 
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 SOL UV PROTECTOR

Active ingredients Purpose

Ethylhexyl Methoxycinnamate 7.00 %.......................................sunscreen
Ethylhexyl Salicylate 4.80 %......................................................sunscreen

Titanium Dioxide 2.07 %............................................................sunscreen

Inactive ingredients

Chamaecyparis Obtusa Water, Glycerin, Chamaecyparis Obtusa Leaf Extract, Butylene Glycol, Niacinamide, Dicaprylyl Carbonate,
Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Diethylamino Hydroxybenzoyl Hexyl Benzoate, Helianthus Tuberosus Extract, 1,2-Hexanediol, Cyclopentasiloxane, Cyclohexasiloxane, Cetearyl Alcohol, Polyglyceryl-3 Methylglucose Distearate, Silica, Lepidium Meyenii Root Extract, Ethyl Hexanediol, Potassium Cetyl Phosphate, Glyceryl Stearate, Stearic Acid, Aloe Barbadensis Leaf Extract, Laminaria Japonica Extract, Dioscorea Japonica Root Extract, Ulmus Davidiana Root Extract, Viola Mandshurica Flower Extract, Aluminum Hydroxide, Ammonium Acryloyldimethyltaurate/VP Copolymer, Glyceryl Caprylate, Water, SodiumAcrylate/Sodium Acryloyldimethyl Taurate Copolymer, Xanthan Gum, Isohexadecane, Adenosine, Dipotassium Glycyrrhizate, Disodium EDTA, Polysorbate 80

TIESO SOL UV PROTECTOR 
ethylhexyl methoxycinnamate, ethylhexyl salicylate, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73184-0050
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.04 g  in 50 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.5 g  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	2.4 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
LEPIDIUM MEYENII ROOT (UNII: HP7119212T)
CHAMAECYPARIS OBTUSA WOOD OIL (UNII: P2OMP71Y62)
GLYCERIN (UNII: PDC6A3C0OX)
NIACINAMIDE (UNII: 25X51I8RD4)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
EDETATE DISODIUM (UNII: 7FLD91C86K)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
LAMINARIA JAPONICA (UNII: WE98HW412B)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)
CHAMAECYPARIS OBTUSA LEAF (UNII: 7OL154J5XB)
BEMOTRIZINOL (UNII: PWZ1720CBH)
STEARIC ACID (UNII: 4ELV7Z65AP)
ADENOSINE (UNII: K72T3FS567)
DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE (UNII: ANQ870JD20)
JERUSALEM ARTICHOKE (UNII: R6PI58X44M)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
ETHOHEXADIOL (UNII: M9JGK7U88V)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
VIOLA MANDSHURICA FLOWER (UNII: 46MR945M6X)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
ISOHEXADECANE (UNII: 918X1OUF1E)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
DIOSCOREA JAPONICA ROOT (UNII: I43FCF3356)
ULMUS DAVIDIANA ROOT (UNII: URQ79U8261)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
XANTHAN GUM (UNII: TTV12P4NEE)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73184-0050-1	1 in 1 BOX	07/21/2020
1		50 mL in 1 CONTAINER; 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	07/21/2020	10/22/2021

Labeler - ANDIVA Inc. (695032533)

Registrant - ANDIVA Inc. (695032533)

Establishment
Name	Address	ID/FEI	Business Operations
ATEC CO., LTD.		689276681	manufacture(73184-0050)

Revised: 10/2021

Document Id: ceea1138-bc54-35c5-e053-2995a90a3b1b

34390-5

Set id: b4c29eac-8ad8-1630-e053-2a95a90af237

Version: 2

Effective Time: 20211022