FDA.reportPublic FDA data

PRO LASER

Product NDC
42248-130
11-digit product format
422480130
Labeler code
42248
Product ID
42248-130_84f78d03-09df-4ca4-ab2e-e7bac2e6551e
Type
HUMAN OTC DRUG
Nonproprietary name
OCTINOXATE, TITANIUM DIOXIDE, OXYBENZONE
Dosage form
CREAM
Route
TOPICAL
Labeler
Zenith Medicosm SL
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2011-12-01
Marketing end
0000-00-00
Substance
OCTINOXATE; TITANIUM DIOXIDE; OXYBENZONE
Active strength
11 mL/150mL; mL/150mL; mL/150mL
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
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42248-130-012019-11-13C16284748780-197449f38-d3e5-f6ea-e053-dbdaa90aa703Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42248-130-01PRO LASERBODY150 mL in 1 BOTTLECREAM1501

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD51PRO LASER BODY (OCTINOXATE, TITANIUM DIOXIDE, OXYBENZONE) CREAM [ZENITH MEDICOSM SL]1
OXYBENZONEACTIVE INGREDIENT95OOS7VE0YPRO LASER BODY (OCTINOXATE, TITANIUM DIOXIDE, OXYBENZONE) CREAM [ZENITH MEDICOSM SL]1
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JPPRO LASER BODY (OCTINOXATE, TITANIUM DIOXIDE, OXYBENZONE) CREAM [ZENITH MEDICOSM SL]1
OCTINOXATEACTIVE MOIETY4Y5P7MUD51PRO LASER BODY (OCTINOXATE, TITANIUM DIOXIDE, OXYBENZONE) CREAM [ZENITH MEDICOSM SL]1
OXYBENZONEACTIVE MOIETY95OOS7VE0YPRO LASER BODY (OCTINOXATE, TITANIUM DIOXIDE, OXYBENZONE) CREAM [ZENITH MEDICOSM SL]1
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JPPRO LASER BODY (OCTINOXATE, TITANIUM DIOXIDE, OXYBENZONE) CREAM [ZENITH MEDICOSM SL]1
(2-CARBETHOXYETHYL)DIETHOXY(METHYL)SILANEINACTIVE INGREDIENTN28HAC3H5PPRO LASER BODY (OCTINOXATE, TITANIUM DIOXIDE, OXYBENZONE) CREAM [ZENITH MEDICOSM SL]1
ALPHA-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0PRO LASER BODY (OCTINOXATE, TITANIUM DIOXIDE, OXYBENZONE) CREAM [ZENITH MEDICOSM SL]1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933PRO LASER BODY (OCTINOXATE, TITANIUM DIOXIDE, OXYBENZONE) CREAM [ZENITH MEDICOSM SL]1
ASPARTIC ACIDINACTIVE INGREDIENT30KYC7MIAIPRO LASER BODY (OCTINOXATE, TITANIUM DIOXIDE, OXYBENZONE) CREAM [ZENITH MEDICOSM SL]1
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8PRO LASER BODY (OCTINOXATE, TITANIUM DIOXIDE, OXYBENZONE) CREAM [ZENITH MEDICOSM SL]1
CARBOMER 934INACTIVE INGREDIENTZ135WT9208PRO LASER BODY (OCTINOXATE, TITANIUM DIOXIDE, OXYBENZONE) CREAM [ZENITH MEDICOSM SL]1
COCONUT ACIDINACTIVE INGREDIENT40U37V505DPRO LASER BODY (OCTINOXATE, TITANIUM DIOXIDE, OXYBENZONE) CREAM [ZENITH MEDICOSM SL]1
COLLAGEN, SOLUBLE, FISH SKININACTIVE INGREDIENT8JC99XGU4WPRO LASER BODY (OCTINOXATE, TITANIUM DIOXIDE, OXYBENZONE) CREAM [ZENITH MEDICOSM SL]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KPRO LASER BODY (OCTINOXATE, TITANIUM DIOXIDE, OXYBENZONE) CREAM [ZENITH MEDICOSM SL]1
ETHYLPARABENINACTIVE INGREDIENT14255EXE39PRO LASER BODY (OCTINOXATE, TITANIUM DIOXIDE, OXYBENZONE) CREAM [ZENITH MEDICOSM SL]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXPRO LASER BODY (OCTINOXATE, TITANIUM DIOXIDE, OXYBENZONE) CREAM [ZENITH MEDICOSM SL]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4PRO LASER BODY (OCTINOXATE, TITANIUM DIOXIDE, OXYBENZONE) CREAM [ZENITH MEDICOSM SL]1
HYDROGENATED SOYBEAN LECITHININACTIVE INGREDIENTH1109Z9J4NPRO LASER BODY (OCTINOXATE, TITANIUM DIOXIDE, OXYBENZONE) CREAM [ZENITH MEDICOSM SL]1
HYDROLYZED ELASTIN, BOVINE, ALKALINE (1000 MW)INACTIVE INGREDIENTZR28QKN0WTPRO LASER BODY (OCTINOXATE, TITANIUM DIOXIDE, OXYBENZONE) CREAM [ZENITH MEDICOSM SL]1
HYDROXYPROLINEINACTIVE INGREDIENTRMB44WO89XPRO LASER BODY (OCTINOXATE, TITANIUM DIOXIDE, OXYBENZONE) CREAM [ZENITH MEDICOSM SL]1
IMIDUREAINACTIVE INGREDIENTM629807ATLPRO LASER BODY (OCTINOXATE, TITANIUM DIOXIDE, OXYBENZONE) CREAM [ZENITH MEDICOSM SL]1
ISOBUTYLPARABENINACTIVE INGREDIENT0QQJ25X58GPRO LASER BODY (OCTINOXATE, TITANIUM DIOXIDE, OXYBENZONE) CREAM [ZENITH MEDICOSM SL]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TPRO LASER BODY (OCTINOXATE, TITANIUM DIOXIDE, OXYBENZONE) CREAM [ZENITH MEDICOSM SL]1
METHYLPARABEN SODIUMINACTIVE INGREDIENTCR6K9C2NHKPRO LASER BODY (OCTINOXATE, TITANIUM DIOXIDE, OXYBENZONE) CREAM [ZENITH MEDICOSM SL]1
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999RPRO LASER BODY (OCTINOXATE, TITANIUM DIOXIDE, OXYBENZONE) CREAM [ZENITH MEDICOSM SL]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TPRO LASER BODY (OCTINOXATE, TITANIUM DIOXIDE, OXYBENZONE) CREAM [ZENITH MEDICOSM SL]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHPRO LASER BODY (OCTINOXATE, TITANIUM DIOXIDE, OXYBENZONE) CREAM [ZENITH MEDICOSM SL]1
SODIUM POLYACRYLATE (8000 MW)INACTIVE INGREDIENT285CYO341LPRO LASER BODY (OCTINOXATE, TITANIUM DIOXIDE, OXYBENZONE) CREAM [ZENITH MEDICOSM SL]1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKPRO LASER BODY (OCTINOXATE, TITANIUM DIOXIDE, OXYBENZONE) CREAM [ZENITH MEDICOSM SL]1
WATERINACTIVE INGREDIENT059QF0KO0RPRO LASER BODY (OCTINOXATE, TITANIUM DIOXIDE, OXYBENZONE) CREAM [ZENITH MEDICOSM SL]1
WHITE WAXINACTIVE INGREDIENT7G1J5DA97FPRO LASER BODY (OCTINOXATE, TITANIUM DIOXIDE, OXYBENZONE) CREAM [ZENITH MEDICOSM SL]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42248-130PRO LASER BODY (OCTINOXATE, TITANIUM DIOXIDE, OXYBENZONE) CREAM [ZENITH MEDICOSM SL]1Legacy NDC, 1 package rows20120524_bfa5d2c4-9b40-491c-ab80-cb9c84d9e680.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
42248-130-0142248013001150 mL in 1 BOTTLE150 mlHistorical