IM SPORTS AQUA SUNGEL- octyl methoxycinnamate, homosalate, octyl salicylate lotion

IM SPORTS AQUA SUNGEL by

Drug Labeling and Warnings

IM SPORTS AQUA SUNGEL by is a Otc medication manufactured, distributed, or labeled by Normalest Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRINCIPAL DISPLAY PANEL

Active ingredients

Octyl Methoxycinnamate 7%

Homosalate 6%

Octyl Salicylate 4.5%

Inactive ingredients

Water, Diethylamino Hydroxybenzoyl Hexyl Benzoate, Propanediol, Dimethicone Crosspolymer, Pentylene Glycol, Ammonium Acryloyldimethyltaurate/VP Copolymer, Salvia Hispanica Seed Extract, Centella Asiatica Extract, Houttuynia Cordata Extract, Phenoxyethanol, Fragrance, Fructooligosaccharides, Saccharide Hydrolysate, Pullulan, Acrylates/C10-30 Alkyl Acrylate, Crosspolymer, Ethylhexylglycerin, Triethanolamine, Octyldodecanol, 1,2-Hexanediol, Echium Plantagineum Seed Oil, Butylene Glycol, Glycerin, Alcohol, Cardiospermum Halicacabum Flower/Leaf/Vine Extract, Helianthus Annuus (Sunflower) Seed Oil Unsaponifiables, Achillea Millefolium Extract, Alchemilla Vulgaris Extract, Malva Sylvestris (Mallow) Extract, Melissa Officinalis Leaf Extract, Mentha Piperita (Peppermint) Leaf Extract, Primula Veris Extract, Veronica Officinalis Extract, Aloe Barbadensis Leaf Extract, Tocopherol, Sodium Hydroxide

INGREDIENTS AND APPEARANCE

IM SPORTS AQUA SUNGEL 
octyl methoxycinnamate, homosalate, octyl salicylate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72284-0006
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.5 g  in 50 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	3 g  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	2.25 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE (UNII: ANQ870JD20)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
PROPANEDIOL (UNII: 5965N8W85T)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
HOUTTUYNIA CORDATA WHOLE (UNII: O3E12ZLW5T)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
SALVIA HISPANICA SEED (UNII: NU0OLX06F8)
CENTELLA ASIATICA (UNII: 7M867G6T1U)
FOSFRUCTOSE (UNII: M7522JYX1H)
INVERT SUGAR (UNII: ED959S6ACY)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
OCTYLDODECANOL (UNII: 461N1O614Y)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
ECHIUM PLANTAGINEUM SEED OIL (UNII: PIB7XBU8XW)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
MENTHA PIPERITA LEAF (UNII: A389O33LX6)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
TOCOPHEROL (UNII: R0ZB2556P8)
WATER (UNII: 059QF0KO0R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PULLULAN (UNII: 8ZQ0AYU1TT)
TROLAMINE (UNII: 9O3K93S3TK)
GLYCERIN (UNII: PDC6A3C0OX)
ALCOHOL (UNII: 3K9958V90M)
CARDIOSPERMUM HALICACABUM WHOLE (UNII: 185RQ97K0V)
MALVA SYLVESTRIS WHOLE (UNII: I01732476C)
ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK)
MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219)
PRIMULA VERIS (UNII: W6LFQ57E4M)
VERONICA OFFICINALIS WHOLE (UNII: 9EHR580PSP)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72284-0006-1	1 in 1 BOX	03/06/2019
1		50 mL in 1 TUBE; 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	03/06/2019

Labeler - Normalest Co., Ltd. (694812877)

Registrant - Normalest Co., Ltd. (694812877)

Establishment
Name	Address	ID/FEI	Business Operations
Normalest Co., Ltd.		694812877	manufacture(72284-0006)