sMTS Dual HA SUN BLOCK by Sonovio LLC

Drug Details [pdf]

SMTS DUAL HA SUN BLOCK- smts dual ha sun block cream
Sonovio LLC
Reference Label Set Id: 1f40912f-8f5a-920a-e063-6394a90a656f

----------

Label

Sunscreen

Uses

A light, multi-purpose antioxidant day cream formulated to moisturize and protect from photodamage.

Warnings

①For external use only.
② When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
③Stop use and ask a doctor if irrrtion or rash occurs. These may be signs of a serious condition.
④Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away,
⑤If swallowed, get medical help or contact a Poison Control Center rightaway.

Do not use on damaged or broken skin.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away,

Directions

After cleansing, apply generously to entire face and neck area 15-30 mins prior to sun exposure. Reapply as needed.

Other information

Store between 15-30C (59-86F)

Inactive Ingredients

Water, Cyclopentasiloxane, Butylene Glycol, Cetyl Ethylhexanoate, Dimethicone Copolyol, Cyclohexasiloxane,

Cyclomethicone, Quaternium-18 Bentonite, lsopropyl Myristate , PEG-10 Glyceryl Triisostearate,

Butyrospermum Parkii (Shea) Butter, Hexyl Laurate, Magnesium Sulfate, Alumina, Chlorphenesin, Fragrance,

Tocopheryl Acetate, Dimethicone, Allantoin, Griffonia Simplicifolia Seed Extract, Phenoxyethanol, Sodium
Hyaluronate, Scutellaria Baicalensis Root Extract, Ethylhexylglycerin, Alpha-lsomethyl lonone, Benzyl Salicylate,

Citronellol, Limonene, Geraniol, Linalool

undefined

SMTS DUAL HA SUN BLOCK
smts dual ha sun block cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84609-001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	2.94 g in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.4 g in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES (UNII: 0C9AC7D6XU)
CHLORPHENESIN (UNII: I670DAL4SZ)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
BENTOQUATAM (UNII: 7F465U79Q1)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
PEG-10 GLYCERYL TRIISOSTEARATE (UNII: 8U46MJI8HO)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
GRIFFONIA SIMPLICIFOLIA SEED (UNII: LUS5142TMY)
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
DIMETHICONE (UNII: 92RU3N3Y1O)
ALLANTOIN (UNII: 344S277G0Z)
CYCLOMETHICONE (UNII: NMQ347994Z)
ALUMINUM OXIDE (UNII: LMI26O6933)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
GERANIOL (UNII: L837108USY)
HEXYL LAURATE (UNII: 4CG9F9W01Q)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 84609-001-01	60 g in 1 BOTTLE; Type 0: Not a Combination Product	08/01/2024	07/30/2025

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	08/01/2024	07/30/2025

Labeler - Sonovio LLC (119201052)

Name	Address	ID/FEI	Business Operations
Establishment
Sonovio LLC		119201052	manufacture(84609-001)

Revised: 7/2025

Document Id: 3b1dbc53-5b68-3e25-e063-6294a90ad79c

Set id: 1f92130c-def5-0706-e063-6394a90abad9

Version: 3

Effective Time: 20250729