FDA.reportPublic FDA data

IM SPORTS AQUA SUNGEL

Manufacturer
Normalest Co., Ltd.
Effective date
2019-03-06
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:58:42

Label at a glance#

ProductIM SPORTS AQUA SUNGEL
Active ingredientOCTINOXATE, HOMOSALATE, OCTISALATE
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

44

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

Octyl Methoxycinnamate 7%

Homosalate 6%

Octyl Salicylate 4.5%

INACTIVE INGREDIENT SECTION

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

OTC - ASK DOCTOR SECTION

OTC - ASK DOCTOR/PHARMACIST SECTION

OTC - DO NOT USE SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

OTC - PURPOSE SECTION

OTC - STOP USE SECTION

OTC - WHEN USING SECTION

WARNINGS SECTION

DOSAGE & ADMINISTRATION SECTION

OTHER SAFETY INFORMATION

STATEMENT OF IDENTITY SECTION

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72284-0006-12022-01-28C16284748780-1d6a99b39-b8cb-a426-e053-dadaa90af4c283581bfd-ffa9-5600-e053-2a91aa0a039a

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72284-0006-1IM SPORTS AQUA SUNGEL50 mL in 1 TUBELOTION501
72284-0006-1IM SPORTS AQUA SUNGEL1 in 1 BOXLOTION11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72284-0006IM SPORTS AQUA SUNGEL (OCTYL METHOXYCINNAMATE, HOMOSALATE, OCTYL SALICYLATE) LOTION [NORMALEST CO., LTD.]1Legacy NDC, 2 package rows20190306_83581bfd-ffa9-5600-e053-2a91aa0a039a.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 36 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72284-000672284-0006-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 34 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATEANQ870JD20IACT
SODIUM HYDROXIDE55X04QC32IIACT
PROPANEDIOL5965N8W85TIACT
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE)UF7620L1W6IACT
HOUTTUYNIA CORDATA WHOLEO3E12ZLW5TIACT
PENTYLENE GLYCOL50C1307PZGIACT
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMERW59H9296ZGIACT
SALVIA HISPANICA SEEDNU0OLX06F8IACT
CENTELLA ASIATICA7M867G6T1UIACT
FOSFRUCTOSEM7522JYX1HIACT
INVERT SUGARED959S6ACYIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
OCTYLDODECANOL461N1O614YIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
ECHIUM PLANTAGINEUM SEED OILPIB7XBU8XWIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
MENTHA PIPERITA LEAFA389O33LX6IACT
ALOE VERA LEAFZY81Z83H0XIACT
TOCOPHEROLR0ZB2556P8IACT
OCTINOXATE4Y5P7MUD51ACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
WATER059QF0KO0RIACT
PHENOXYETHANOLHIE492ZZ3TIACT
PULLULAN8ZQ0AYU1TTIACT
TROLAMINE9O3K93S3TKIACT
GLYCERINPDC6A3C0OXIACT
ALCOHOL3K9958V90MIACT
CARDIOSPERMUM HALICACABUM WHOLE185RQ97K0VIACT
MALVA SYLVESTRIS WHOLEI01732476CIACT
ACHILLEA MILLEFOLIUM2FXJ6SW4PKIACT
MELISSA OFFICINALIS LEAF50D2ZE9219IACT
PRIMULA VERISW6LFQ57E4MIACT
VERONICA OFFICINALIS WHOLE9EHR580PSPIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
83581bfd-ffaa-5600-e053-2a91aa0a039a83581bfd-ffa9-5600-e053-2a91aa0a039a2019-03-06Exact identifier
spl id: 83581bfd-ffaa-5600-e053-2a91aa0a039a
spl set id: 83581bfd-ffa9-5600-e053-2a91aa0a039a

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.