FDA.reportPublic FDA data

NDC 49520-902 - CALM IT DOWN KIT

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
49520-902
Manufacturer
mybody
Effective date
2014-06-30
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
CALM IT DOWN KIT - mybodymybody2014-06-30HUMAN OTC DRUG LABEL
REVERSE IT KIT - mybodymybody2014-06-30HUMAN OTC DRUG LABEL

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JPREVERSE IT KIT (TITANIUM DIOXIDE, ZINC OXIDE) KIT [MYBODY]1
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JPCALM IT DOWN KIT (TITANIUM DIOXIDE, ZINC OXIDE) KIT [MYBODY]1
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54ZCALM IT DOWN KIT (TITANIUM DIOXIDE, ZINC OXIDE) KIT [MYBODY]1
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54ZREVERSE IT KIT (TITANIUM DIOXIDE, ZINC OXIDE) KIT [MYBODY]1
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JPCALM IT DOWN KIT (TITANIUM DIOXIDE, ZINC OXIDE) KIT [MYBODY]1
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JPREVERSE IT KIT (TITANIUM DIOXIDE, ZINC OXIDE) KIT [MYBODY]1
ZINC OXIDEACTIVE MOIETYSOI2LOH54ZREVERSE IT KIT (TITANIUM DIOXIDE, ZINC OXIDE) KIT [MYBODY]1
ZINC OXIDEACTIVE MOIETYSOI2LOH54ZCALM IT DOWN KIT (TITANIUM DIOXIDE, ZINC OXIDE) KIT [MYBODY]1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933REVERSE IT KIT (TITANIUM DIOXIDE, ZINC OXIDE) KIT [MYBODY]1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933CALM IT DOWN KIT (TITANIUM DIOXIDE, ZINC OXIDE) KIT [MYBODY]1
CALCIUM BEHENATEINACTIVE INGREDIENTJ5VFA9V6YGCALM IT DOWN KIT (TITANIUM DIOXIDE, ZINC OXIDE) KIT [MYBODY]1
CALCIUM BEHENATEINACTIVE INGREDIENTJ5VFA9V6YGREVERSE IT KIT (TITANIUM DIOXIDE, ZINC OXIDE) KIT [MYBODY]1
CHOLECALCIFEROLINACTIVE INGREDIENT1C6V77QF41CALM IT DOWN KIT (TITANIUM DIOXIDE, ZINC OXIDE) KIT [MYBODY]1
CHOLECALCIFEROLINACTIVE INGREDIENT1C6V77QF41REVERSE IT KIT (TITANIUM DIOXIDE, ZINC OXIDE) KIT [MYBODY]1
CYCLOMETHICONEINACTIVE INGREDIENTNMQ347994ZREVERSE IT KIT (TITANIUM DIOXIDE, ZINC OXIDE) KIT [MYBODY]1
CYCLOMETHICONEINACTIVE INGREDIENTNMQ347994ZCALM IT DOWN KIT (TITANIUM DIOXIDE, ZINC OXIDE) KIT [MYBODY]1
CYCLOMETHICONE 5INACTIVE INGREDIENT0THT5PCI0RCALM IT DOWN KIT (TITANIUM DIOXIDE, ZINC OXIDE) KIT [MYBODY]1
CYCLOMETHICONE 5INACTIVE INGREDIENT0THT5PCI0RREVERSE IT KIT (TITANIUM DIOXIDE, ZINC OXIDE) KIT [MYBODY]1
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)INACTIVE INGREDIENT9E4CO0W6C5REVERSE IT KIT (TITANIUM DIOXIDE, ZINC OXIDE) KIT [MYBODY]1
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)INACTIVE INGREDIENT9E4CO0W6C5CALM IT DOWN KIT (TITANIUM DIOXIDE, ZINC OXIDE) KIT [MYBODY]1
DIMETHICONOL (41 MPA.S)INACTIVE INGREDIENT343C7U75XWCALM IT DOWN KIT (TITANIUM DIOXIDE, ZINC OXIDE) KIT [MYBODY]1
DIMETHICONOL (41 MPA.S)INACTIVE INGREDIENT343C7U75XWREVERSE IT KIT (TITANIUM DIOXIDE, ZINC OXIDE) KIT [MYBODY]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675REVERSE IT KIT (TITANIUM DIOXIDE, ZINC OXIDE) KIT [MYBODY]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675CALM IT DOWN KIT (TITANIUM DIOXIDE, ZINC OXIDE) KIT [MYBODY]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCALM IT DOWN KIT (TITANIUM DIOXIDE, ZINC OXIDE) KIT [MYBODY]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXREVERSE IT KIT (TITANIUM DIOXIDE, ZINC OXIDE) KIT [MYBODY]1
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62CALM IT DOWN KIT (TITANIUM DIOXIDE, ZINC OXIDE) KIT [MYBODY]1
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62REVERSE IT KIT (TITANIUM DIOXIDE, ZINC OXIDE) KIT [MYBODY]1
LYCOPENEINACTIVE INGREDIENTSB0N2N0WV6REVERSE IT KIT (TITANIUM DIOXIDE, ZINC OXIDE) KIT [MYBODY]1
LYCOPENEINACTIVE INGREDIENTSB0N2N0WV6CALM IT DOWN KIT (TITANIUM DIOXIDE, ZINC OXIDE) KIT [MYBODY]1
MELANIN SYNTHETIC (TYROSINE, PEROXIDE)INACTIVE INGREDIENTO0CV1RMR44REVERSE IT KIT (TITANIUM DIOXIDE, ZINC OXIDE) KIT [MYBODY]1
MELANIN SYNTHETIC (TYROSINE, PEROXIDE)INACTIVE INGREDIENTO0CV1RMR44CALM IT DOWN KIT (TITANIUM DIOXIDE, ZINC OXIDE) KIT [MYBODY]1
METHICONE (20 CST)INACTIVE INGREDIENT6777U11MKTCALM IT DOWN KIT (TITANIUM DIOXIDE, ZINC OXIDE) KIT [MYBODY]1
METHICONE (20 CST)INACTIVE INGREDIENT6777U11MKTREVERSE IT KIT (TITANIUM DIOXIDE, ZINC OXIDE) KIT [MYBODY]1
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMERINACTIVE INGREDIENTEG97988M5QCALM IT DOWN KIT (TITANIUM DIOXIDE, ZINC OXIDE) KIT [MYBODY]1
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMERINACTIVE INGREDIENTEG97988M5QREVERSE IT KIT (TITANIUM DIOXIDE, ZINC OXIDE) KIT [MYBODY]1
PEG-10 DIMETHICONE (600 CST)INACTIVE INGREDIENT8PR7V1SVM0REVERSE IT KIT (TITANIUM DIOXIDE, ZINC OXIDE) KIT [MYBODY]1
PEG-10 DIMETHICONE (600 CST)INACTIVE INGREDIENT8PR7V1SVM0CALM IT DOWN KIT (TITANIUM DIOXIDE, ZINC OXIDE) KIT [MYBODY]1
SORBITAN ISOSTEARATEINACTIVE INGREDIENT01S2G2C1E4CALM IT DOWN KIT (TITANIUM DIOXIDE, ZINC OXIDE) KIT [MYBODY]1
SORBITAN ISOSTEARATEINACTIVE INGREDIENT01S2G2C1E4REVERSE IT KIT (TITANIUM DIOXIDE, ZINC OXIDE) KIT [MYBODY]1
SUCROSE PALMITATEINACTIVE INGREDIENT3OSQ643ZK5REVERSE IT KIT (TITANIUM DIOXIDE, ZINC OXIDE) KIT [MYBODY]1
SUCROSE PALMITATEINACTIVE INGREDIENT3OSQ643ZK5CALM IT DOWN KIT (TITANIUM DIOXIDE, ZINC OXIDE) KIT [MYBODY]1
TRIBEHENININACTIVE INGREDIENT8OC9U7TQZ0CALM IT DOWN KIT (TITANIUM DIOXIDE, ZINC OXIDE) KIT [MYBODY]1
TRIBEHENININACTIVE INGREDIENT8OC9U7TQZ0REVERSE IT KIT (TITANIUM DIOXIDE, ZINC OXIDE) KIT [MYBODY]1

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 281 of 324 · 6,478 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydro GelGLYCERIN 20%Trifecta Pharmaceuticals USA LLC02e8e5d0-7844-39fe-e063-6394a90a57e12024-01-19WarningsExact identifier
unii: PDC6A3C0OX
Leader Zinc OxideZINC OXIDECardinal Health 110,Inc.4d675dfd-6ea9-4aa7-a4ff-bb84f87ff7d12024-01-18WarningsExact identifier
unii: SOI2LOH54Z
BuscapinaACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATEOPMX LLCe0dd4c04-6811-38a1-e053-2995a90aa3c92024-01-17WarningsExact identifier
unii: 3G6A5W338E
Shunly Zn20 Light MoisturizerZINC OXIDEShunly Skin Care LLCd5710d48-0a4b-49a6-b6b5-9a192afccd2a2024-01-17WarningsExact identifier
unii: SOI2LOH54Z
Shunly Zn20 Tinted Light MoisturizerZINC OXIDEShunly Skin Care LLCc046eef3-c2d7-42e6-a5ad-98e513fdb4e12024-01-17WarningsExact identifier
unii: SOI2LOH54Z
Shunly Radiant Translucent SPF 40TITANIUM DIOXIDE, ZINC OXIDEShunly Skin Care LLC20783833-ee7f-4425-b4ab-ab61cda5b2c82024-01-17WarningsExact identifier
unii: SOI2LOH54Z
unii: 15FIX9V2JP
Shunly Radiant Translucent Tinted SPF 40TITANIUM DIOXIDE, ZINC OXIDEShunly Skin Care LLC1aeb5e05-730c-4c5c-b164-ad9347b0cd932024-01-17WarningsExact identifier
unii: SOI2LOH54Z
unii: 15FIX9V2JP
PNV-SelectVITAMIN A ACETATE, ASCORBIC ACID, CHOLECALCIFEROL, ALPHA-TOCOPHEROL ACETATE, DL, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, BIOTIN, CALCIUM PANTOTHENATE, CALCIUM CARBONATE, FERROUS FUMARATE, POTASSIUM IODIDE, MAGNESIUM OXIDE, ZINC OXIDE AND CUPRIC OXIDEAcella Pharmaceuticals, LLC9f4ce551-7a80-4ddb-a014-95c44b54a4202024-01-16Boxed warning, Adverse reactionsExact identifier
unii: SOI2LOH54Z
unii: 1C6V77QF41
Cerave Developed with Dermatologists Hydrating Sunscreen SPF 50 Body Lightweight, non-greasy feel 3 essential ceramides Mineral SunscreenTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Inc4a243c9f-ca88-47fb-8777-1da79c001c732024-01-16WarningsExact identifier
unii: SOI2LOH54Z
unii: 15FIX9V2JP
MY MEDIC SPF 30 REEF FRIENDLY SUNSCREENHOMOSALATE, TITANIUM DIOXIDE, ETHYLHEXYL SALICYLATE, PHENYLBENZIMIDAZOLE SULFONIC ACIDSled Distribution, LLCec252876-7205-83ec-e053-2a95a90a14632024-01-15WarningsExact identifier
unii: 15FIX9V2JP
La Roche Posay Laboratoire Dermatologique Anthelios 50 Tinted Mineral Sunscreen Broad Spectrum SPF 50TITANIUM DIOXIDECosmetique Active Productionfd2541e1-c409-40a8-9e3f-6ff69084ea662024-01-15WarningsExact identifier
unii: 15FIX9V2JP
La Roche Posay Laboratoire Dermatologique Anthelios 50 Tinted Mineral Face Broad Spectrum SPF 50 SunscreenTITANIUM DIOXIDEL'Oreal USA Products Incbc72048a-4786-44c2-97ce-0220822816542024-01-15WarningsExact identifier
unii: 15FIX9V2JP
Sunmark CaldiphenCALAMINE AND PRAMOXINE HYDROCHLORIDEStrategic Sourcing Services4f4d4c54-64b5-4e20-bed0-c7fb470b84342024-01-12WarningsExact identifier
unii: SOI2LOH54Z
EIGHT HOUR NIGHTDIMETHICONEREVLONb3b277f9-565a-636c-e053-2995a90a94d22024-01-12WarningsExact identifier
unii: 92RU3N3Y1O
Revlon Colorstay Light Cover FoundationHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE,ZINC OXIDERevlonb0006b5f-0d56-0efb-e053-2a95a90a59792024-01-12WarningsExact identifier
unii: SOI2LOH54Z
unii: 15FIX9V2JP
PREVAGE CITY SMARTTITANIUM DIOXIDE, ZINC OXIDEREVLONb60c9b41-cf32-ee94-e053-2a95a90abab02024-01-12WarningsExact identifier
unii: SOI2LOH54Z
unii: 15FIX9V2JP
CERAMIDE MAKEUP SPF 15OCTINOXATE, TITANIUM DIOXIDEREVLONb3ad9686-47ed-4b60-e053-2995a90abcdd2024-01-12WarningsExact identifier
unii: 15FIX9V2JP
Principal Secret Reclaim Botanical (with SP) Radiant Recovery Day Broad Spectrum SPF 15OCTINOXATE, OCTISALATE, AND ZINC OXIDEGuthy-Renker LLC6437fbf6-c84b-497e-bf69-b20153d4c7062024-01-11WarningsExact identifier
unii: SOI2LOH54Z
Maximum Strength Gas Relief SoftgelSIMETHICONECardinal Health 110, LLC. DBA Leader57043cae-a8db-4eff-835c-5995e8aea9242024-01-11WarningsExact identifier
unii: 92RU3N3Y1O
Quflora PediatricVITAMIN A ACETATE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, DL-, THIAMINE HYDROCHLORIDE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, LEVOMEFOLIC ACID, FOLIC ACID, CYANOCOBALAMIN, MAGNESIUM OXIDE, CUPRIC SULFATE, AND SODIUM FLUORIDECarWin Pharmaceutical Associates, LLCb8e08798-d8bb-4616-996b-a2c07a5d730a2024-01-10Warnings, Adverse reactionsExact identifier
unii: 1C6V77QF41

Reported adverse events (FAERS/openFDA)#

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