FDA.reportPublic FDA data

WhiteWater Advanced Brightening

Product NDC
65903-250
11-digit product format
659030250
Labeler code
65903
Product ID
65903-250_85527fb2-ccec-4fbd-b0a7-c44eeeee018f
Type
HUMAN OTC DRUG
Nonproprietary name
Homosalate,Oxybenzone,Octisalate,Avobenzone
Dosage form
LOTION
Route
TOPICAL
Labeler
H2O PLUS
Application
part352
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2012-03-01
Marketing end
0000-00-00
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE; OXYBENZONE
Active strength
3 mL/100mL; mL/100mL; mL/100mL; mL/100mL
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
65903-250-012019-11-13C16284748780-197449f38-c2a5-f6ea-e053-dbdaa90aa703Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65903-250-01WhiteWater Advanced BrighteningWhiteWater Advanced Brightening SPF301 in 1 CARTONLOTION11
65903-250-01WhiteWater Advanced BrighteningWhiteWater Advanced Brightening SPF3038 mL in 1 BOTTLE, PUMPLOTION381

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AvobenzoneACTIVE INGREDIENTG63QQF2NOXWHITEWATER ADVANCED BRIGHTENING WHITEWATER ADVANCED BRIGHTENING SPF30 (HOMOSALATE,OXYBENZONE,OCTISALATE,AVOBENZONE) LOTION [H2O PLUS]1
HomosalateACTIVE INGREDIENTV06SV4M95SWHITEWATER ADVANCED BRIGHTENING WHITEWATER ADVANCED BRIGHTENING SPF30 (HOMOSALATE,OXYBENZONE,OCTISALATE,AVOBENZONE) LOTION [H2O PLUS]1
OctisalateACTIVE INGREDIENT4X49Y0596WWHITEWATER ADVANCED BRIGHTENING WHITEWATER ADVANCED BRIGHTENING SPF30 (HOMOSALATE,OXYBENZONE,OCTISALATE,AVOBENZONE) LOTION [H2O PLUS]1
OxybenzoneACTIVE INGREDIENT95OOS7VE0YWHITEWATER ADVANCED BRIGHTENING WHITEWATER ADVANCED BRIGHTENING SPF30 (HOMOSALATE,OXYBENZONE,OCTISALATE,AVOBENZONE) LOTION [H2O PLUS]1
AvobenzoneACTIVE MOIETYG63QQF2NOXWHITEWATER ADVANCED BRIGHTENING WHITEWATER ADVANCED BRIGHTENING SPF30 (HOMOSALATE,OXYBENZONE,OCTISALATE,AVOBENZONE) LOTION [H2O PLUS]1
HomosalateACTIVE MOIETYV06SV4M95SWHITEWATER ADVANCED BRIGHTENING WHITEWATER ADVANCED BRIGHTENING SPF30 (HOMOSALATE,OXYBENZONE,OCTISALATE,AVOBENZONE) LOTION [H2O PLUS]1
OctisalateACTIVE MOIETY4X49Y0596WWHITEWATER ADVANCED BRIGHTENING WHITEWATER ADVANCED BRIGHTENING SPF30 (HOMOSALATE,OXYBENZONE,OCTISALATE,AVOBENZONE) LOTION [H2O PLUS]1
OxybenzoneACTIVE MOIETY95OOS7VE0YWHITEWATER ADVANCED BRIGHTENING WHITEWATER ADVANCED BRIGHTENING SPF30 (HOMOSALATE,OXYBENZONE,OCTISALATE,AVOBENZONE) LOTION [H2O PLUS]1
.ALPHA.-TOCOPHEROL ACETATE, DL-INACTIVE INGREDIENTWR1WPI7EW8WHITEWATER ADVANCED BRIGHTENING WHITEWATER ADVANCED BRIGHTENING SPF30 (HOMOSALATE,OXYBENZONE,OCTISALATE,AVOBENZONE) LOTION [H2O PLUS]1
ALKYL (C12-15) BENZOATEINACTIVE INGREDIENTA9EJ3J61HQWHITEWATER ADVANCED BRIGHTENING WHITEWATER ADVANCED BRIGHTENING SPF30 (HOMOSALATE,OXYBENZONE,OCTISALATE,AVOBENZONE) LOTION [H2O PLUS]1
ASCOPHYLLUM NODOSUMINACTIVE INGREDIENT168S4EO8YJWHITEWATER ADVANCED BRIGHTENING WHITEWATER ADVANCED BRIGHTENING SPF30 (HOMOSALATE,OXYBENZONE,OCTISALATE,AVOBENZONE) LOTION [H2O PLUS]1
BENZYL BENZOATEINACTIVE INGREDIENTN863NB338GWHITEWATER ADVANCED BRIGHTENING WHITEWATER ADVANCED BRIGHTENING SPF30 (HOMOSALATE,OXYBENZONE,OCTISALATE,AVOBENZONE) LOTION [H2O PLUS]1
BENZYL SALICYLATEINACTIVE INGREDIENTWAO5MNK9TUWHITEWATER ADVANCED BRIGHTENING WHITEWATER ADVANCED BRIGHTENING SPF30 (HOMOSALATE,OXYBENZONE,OCTISALATE,AVOBENZONE) LOTION [H2O PLUS]1
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RAWHITEWATER ADVANCED BRIGHTENING WHITEWATER ADVANCED BRIGHTENING SPF30 (HOMOSALATE,OXYBENZONE,OCTISALATE,AVOBENZONE) LOTION [H2O PLUS]1
BUTYLPHENYL METHYLPROPIONALINACTIVE INGREDIENTT7540GJV69WHITEWATER ADVANCED BRIGHTENING WHITEWATER ADVANCED BRIGHTENING SPF30 (HOMOSALATE,OXYBENZONE,OCTISALATE,AVOBENZONE) LOTION [H2O PLUS]1
CETEARYL GLUCOSIDEINACTIVE INGREDIENT09FUA47KNAWHITEWATER ADVANCED BRIGHTENING WHITEWATER ADVANCED BRIGHTENING SPF30 (HOMOSALATE,OXYBENZONE,OCTISALATE,AVOBENZONE) LOTION [H2O PLUS]1
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SWHITEWATER ADVANCED BRIGHTENING WHITEWATER ADVANCED BRIGHTENING SPF30 (HOMOSALATE,OXYBENZONE,OCTISALATE,AVOBENZONE) LOTION [H2O PLUS]1
CITRONELLOL ACETATE, (S)-INACTIVE INGREDIENT78RZL4H51HWHITEWATER ADVANCED BRIGHTENING WHITEWATER ADVANCED BRIGHTENING SPF30 (HOMOSALATE,OXYBENZONE,OCTISALATE,AVOBENZONE) LOTION [H2O PLUS]1
CYCLOMETHICONE 5INACTIVE INGREDIENT0THT5PCI0RWHITEWATER ADVANCED BRIGHTENING WHITEWATER ADVANCED BRIGHTENING SPF30 (HOMOSALATE,OXYBENZONE,OCTISALATE,AVOBENZONE) LOTION [H2O PLUS]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OWHITEWATER ADVANCED BRIGHTENING WHITEWATER ADVANCED BRIGHTENING SPF30 (HOMOSALATE,OXYBENZONE,OCTISALATE,AVOBENZONE) LOTION [H2O PLUS]1
EDETIC ACIDINACTIVE INGREDIENT9G34HU7RV0WHITEWATER ADVANCED BRIGHTENING WHITEWATER ADVANCED BRIGHTENING SPF30 (HOMOSALATE,OXYBENZONE,OCTISALATE,AVOBENZONE) LOTION [H2O PLUS]1
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3PWHITEWATER ADVANCED BRIGHTENING WHITEWATER ADVANCED BRIGHTENING SPF30 (HOMOSALATE,OXYBENZONE,OCTISALATE,AVOBENZONE) LOTION [H2O PLUS]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXWHITEWATER ADVANCED BRIGHTENING WHITEWATER ADVANCED BRIGHTENING SPF30 (HOMOSALATE,OXYBENZONE,OCTISALATE,AVOBENZONE) LOTION [H2O PLUS]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4WHITEWATER ADVANCED BRIGHTENING WHITEWATER ADVANCED BRIGHTENING SPF30 (HOMOSALATE,OXYBENZONE,OCTISALATE,AVOBENZONE) LOTION [H2O PLUS]1
HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDEINACTIVE INGREDIENTQUE43B9Z2QWHITEWATER ADVANCED BRIGHTENING WHITEWATER ADVANCED BRIGHTENING SPF30 (HOMOSALATE,OXYBENZONE,OCTISALATE,AVOBENZONE) LOTION [H2O PLUS]1
ISOHEXADECANEINACTIVE INGREDIENT918X1OUF1EWHITEWATER ADVANCED BRIGHTENING WHITEWATER ADVANCED BRIGHTENING SPF30 (HOMOSALATE,OXYBENZONE,OCTISALATE,AVOBENZONE) LOTION [H2O PLUS]1
ISOMETHYL-.ALPHA.-IONONEINACTIVE INGREDIENT9XP4LC555BWHITEWATER ADVANCED BRIGHTENING WHITEWATER ADVANCED BRIGHTENING SPF30 (HOMOSALATE,OXYBENZONE,OCTISALATE,AVOBENZONE) LOTION [H2O PLUS]1
LAMINARIA DIGITATAINACTIVE INGREDIENT15E7C67EE8WHITEWATER ADVANCED BRIGHTENING WHITEWATER ADVANCED BRIGHTENING SPF30 (HOMOSALATE,OXYBENZONE,OCTISALATE,AVOBENZONE) LOTION [H2O PLUS]1
LIMONENE, (+)-INACTIVE INGREDIENTGFD7C86Q1WWHITEWATER ADVANCED BRIGHTENING WHITEWATER ADVANCED BRIGHTENING SPF30 (HOMOSALATE,OXYBENZONE,OCTISALATE,AVOBENZONE) LOTION [H2O PLUS]1
LINALOOL, (+/-)-INACTIVE INGREDIENTD81QY6I88EWHITEWATER ADVANCED BRIGHTENING WHITEWATER ADVANCED BRIGHTENING SPF30 (HOMOSALATE,OXYBENZONE,OCTISALATE,AVOBENZONE) LOTION [H2O PLUS]1
MAGNESIUM CHLORIDEINACTIVE INGREDIENT02F3473H9OWHITEWATER ADVANCED BRIGHTENING WHITEWATER ADVANCED BRIGHTENING SPF30 (HOMOSALATE,OXYBENZONE,OCTISALATE,AVOBENZONE) LOTION [H2O PLUS]1
MAGNESIUM NITRATEINACTIVE INGREDIENT77CBG3UN78WHITEWATER ADVANCED BRIGHTENING WHITEWATER ADVANCED BRIGHTENING SPF30 (HOMOSALATE,OXYBENZONE,OCTISALATE,AVOBENZONE) LOTION [H2O PLUS]1
METHYLCHLOROISOTHIAZOLINONEINACTIVE INGREDIENTDEL7T5QRPNWHITEWATER ADVANCED BRIGHTENING WHITEWATER ADVANCED BRIGHTENING SPF30 (HOMOSALATE,OXYBENZONE,OCTISALATE,AVOBENZONE) LOTION [H2O PLUS]1
METHYLISOTHIAZOLINONEINACTIVE INGREDIENT229D0E1QFAWHITEWATER ADVANCED BRIGHTENING WHITEWATER ADVANCED BRIGHTENING SPF30 (HOMOSALATE,OXYBENZONE,OCTISALATE,AVOBENZONE) LOTION [H2O PLUS]1
MORUS AUSTRALIS ROOTINACTIVE INGREDIENT1VL55O45RFWHITEWATER ADVANCED BRIGHTENING WHITEWATER ADVANCED BRIGHTENING SPF30 (HOMOSALATE,OXYBENZONE,OCTISALATE,AVOBENZONE) LOTION [H2O PLUS]1
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999RWHITEWATER ADVANCED BRIGHTENING WHITEWATER ADVANCED BRIGHTENING SPF30 (HOMOSALATE,OXYBENZONE,OCTISALATE,AVOBENZONE) LOTION [H2O PLUS]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TWHITEWATER ADVANCED BRIGHTENING WHITEWATER ADVANCED BRIGHTENING SPF30 (HOMOSALATE,OXYBENZONE,OCTISALATE,AVOBENZONE) LOTION [H2O PLUS]1
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MWHITEWATER ADVANCED BRIGHTENING WHITEWATER ADVANCED BRIGHTENING SPF30 (HOMOSALATE,OXYBENZONE,OCTISALATE,AVOBENZONE) LOTION [H2O PLUS]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3WHITEWATER ADVANCED BRIGHTENING WHITEWATER ADVANCED BRIGHTENING SPF30 (HOMOSALATE,OXYBENZONE,OCTISALATE,AVOBENZONE) LOTION [H2O PLUS]1
SAXIFRAGA STOLONIFERA LEAFINACTIVE INGREDIENTO3TMV4903HWHITEWATER ADVANCED BRIGHTENING WHITEWATER ADVANCED BRIGHTENING SPF30 (HOMOSALATE,OXYBENZONE,OCTISALATE,AVOBENZONE) LOTION [H2O PLUS]1
SCUTELLARIA BAICALENSIS ROOTINACTIVE INGREDIENT7J95K7ID2SWHITEWATER ADVANCED BRIGHTENING WHITEWATER ADVANCED BRIGHTENING SPF30 (HOMOSALATE,OXYBENZONE,OCTISALATE,AVOBENZONE) LOTION [H2O PLUS]1
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW)INACTIVE INGREDIENT1DXE3F3OZXWHITEWATER ADVANCED BRIGHTENING WHITEWATER ADVANCED BRIGHTENING SPF30 (HOMOSALATE,OXYBENZONE,OCTISALATE,AVOBENZONE) LOTION [H2O PLUS]1
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3CWHITEWATER ADVANCED BRIGHTENING WHITEWATER ADVANCED BRIGHTENING SPF30 (HOMOSALATE,OXYBENZONE,OCTISALATE,AVOBENZONE) LOTION [H2O PLUS]1
SODIUM SULFITEINACTIVE INGREDIENTVTK01UQK3GWHITEWATER ADVANCED BRIGHTENING WHITEWATER ADVANCED BRIGHTENING SPF30 (HOMOSALATE,OXYBENZONE,OCTISALATE,AVOBENZONE) LOTION [H2O PLUS]1
SPIRULINA MAXIMAINACTIVE INGREDIENT9K7IG15M0QWHITEWATER ADVANCED BRIGHTENING WHITEWATER ADVANCED BRIGHTENING SPF30 (HOMOSALATE,OXYBENZONE,OCTISALATE,AVOBENZONE) LOTION [H2O PLUS]1
TRIETHANOLAMINE HYDROCHLORIDEINACTIVE INGREDIENTR297UJ9QDYWHITEWATER ADVANCED BRIGHTENING WHITEWATER ADVANCED BRIGHTENING SPF30 (HOMOSALATE,OXYBENZONE,OCTISALATE,AVOBENZONE) LOTION [H2O PLUS]1
TRISILOXANEINACTIVE INGREDIENT9G1ZW13R0GWHITEWATER ADVANCED BRIGHTENING WHITEWATER ADVANCED BRIGHTENING SPF30 (HOMOSALATE,OXYBENZONE,OCTISALATE,AVOBENZONE) LOTION [H2O PLUS]1
VITIS VINIFERA FLOWERING TOPINACTIVE INGREDIENT6TG3V35HTVWHITEWATER ADVANCED BRIGHTENING WHITEWATER ADVANCED BRIGHTENING SPF30 (HOMOSALATE,OXYBENZONE,OCTISALATE,AVOBENZONE) LOTION [H2O PLUS]1
waterINACTIVE INGREDIENT059QF0KO0RWHITEWATER ADVANCED BRIGHTENING WHITEWATER ADVANCED BRIGHTENING SPF30 (HOMOSALATE,OXYBENZONE,OCTISALATE,AVOBENZONE) LOTION [H2O PLUS]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEWHITEWATER ADVANCED BRIGHTENING WHITEWATER ADVANCED BRIGHTENING SPF30 (HOMOSALATE,OXYBENZONE,OCTISALATE,AVOBENZONE) LOTION [H2O PLUS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65903-250WHITEWATER ADVANCED BRIGHTENING WHITEWATER ADVANCED BRIGHTENING SPF30 (HOMOSALATE,OXYBENZONE,OCTISALATE,AVOBENZONE) LOTION [H2O PLUS]1Legacy NDC, 2 package rows20120302_146cd569-f4c5-4a78-8cae-97dfc6a568d7.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
65903-250-01659030250011 in 1 CARTONHistorical