SMTS DUAL HA SUN BLOCK cream

sMTS Dual HA SUN BLOCK by

Drug Labeling and Warnings

sMTS Dual HA SUN BLOCK by is a Otc medication manufactured, distributed, or labeled by Sonovio LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Octinoxate 7.0%

Zinc Oxide 2.94%

Titanium Dioxide 2.4%

PURPOSE

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

Do not use on damaged or broken skin.

KEEP OUT OF REACH OF CHILDREN

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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)

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

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

Labeler - Sonovio LLC (119201052)

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