Label: IM SPORTS AQUA SUNGEL- octyl methoxycinnamate, homosalate, octyl salicylate lotion
-
Contains inactivated NDC Code(s)
NDC Code(s): 72284-0006-1 - Packager: Normalest Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated March 6, 2019
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
-
PRINCIPAL DISPLAY PANEL
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 lotionProduct 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)