IM SPORTS AQUA SUNGEL- octyl methoxycinnamate, homosalate, octyl salicylate lotion 
Normalest Co., Ltd.

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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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

IM SPORTS AQUA SUNGEL 
octyl methoxycinnamate, homosalate, octyl salicylate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72284-0006
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3.5 g  in 50 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE3 g  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2.25 g  in 50 mL
Inactive Ingredients
Ingredient NameStrength
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
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72284-0006-11 in 1 BOX03/06/2019
150 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35203/06/2019
Labeler - Normalest Co., Ltd. (694812877)
Registrant - Normalest Co., Ltd. (694812877)
Establishment
NameAddressID/FEIBusiness Operations
Normalest Co., Ltd.694812877manufacture(72284-0006)

Revised: 3/2019
Document Id: 83581bfd-ffaa-5600-e053-2a91aa0a039a
Set id: 83581bfd-ffa9-5600-e053-2a91aa0a039a
Version: 1
Effective Time: 20190306
 
Normalest Co., Ltd.