FDA.reportPublic FDA data

NDC 49520-903 - 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
49520-903
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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
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
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JPCALM IT DOWN KIT (TITANIUM DIOXIDE, ZINC OXIDE) KIT [MYBODY]1
ZINC OXIDEACTIVE MOIETYSOI2LOH54ZCALM IT DOWN 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
CHOLECALCIFEROLINACTIVE INGREDIENT1C6V77QF41CALM IT DOWN 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
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
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
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62CALM IT DOWN 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 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
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMERINACTIVE INGREDIENTEG97988M5QCALM IT DOWN 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
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

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 20 of 273 · 5,459 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Riversol Tinted Lip Oil - PoppyZINC OXIDERiversol52b92725-6d9a-768a-e063-6394a90ac9332026-05-26WarningsExact identifier
unii: SOI2LOH54Z
CalamineCALAMINE AND ZINC OXIDEPharma Nobis, LLCfbcfa541-beda-06de-e053-6294a90a92982026-05-26WarningsExact identifier
unii: SOI2LOH54Z
unii: 1K09F3G675
Odacite Nourishing Lip Serum - Jazzy BerryZINC OXIDEOdacite52b97fb0-84d6-a408-e063-6294a90a9be92026-05-26WarningsExact identifier
unii: SOI2LOH54Z
Odacite Nourishing Lip Serum - True NudeZINC OXIDEOdacite52b9be2a-4958-f537-e063-6294a90a7a1b2026-05-26WarningsExact identifier
unii: SOI2LOH54Z
Riversol Tinted Lip Oil - PoppyZINC OXIDESolesence, Inc.52ba09cb-edcc-a405-e063-6394a90a6aab2026-05-26WarningsExact identifier
unii: SOI2LOH54Z
Humco CalamineCALAMINE 8% AND ZINC OXIDE 8%Humco holding Group, Inc.f7dcd959-fb98-43bb-8dd3-a662bf8a053c2026-05-26WarningsExact identifier
unii: SOI2LOH54Z
Odacite Nourishing Lip Serum - Bubble GumZINC OXIDEOdacite52b9fb0a-0554-0de2-e063-6294a90a09d32026-05-26WarningsExact identifier
unii: SOI2LOH54Z
Riversol Tinted Lip Oil - RosewoodZINC OXIDESolesence, Inc.52ba07f1-b74e-a4b6-e063-6394a90a74732026-05-26WarningsExact identifier
unii: SOI2LOH54Z
Broad Spectrum SPF 50 SunscreenZINC OXIDESKIN DAMAGE INC.52ba2f12-839f-cea1-e063-6394a90a5ae62026-05-26WarningsExact identifier
unii: SOI2LOH54Z
Odacite Color Balm - Bronze JolieZINC OXIDEOdacite52ba360e-375c-0469-e063-6294a90a020e2026-05-26WarningsExact identifier
unii: SOI2LOH54Z
Odacite Color Balm - Golden HourZINC OXIDEOdacite52ba8e03-1944-b73d-e063-6294a90a50392026-05-26WarningsExact identifier
unii: SOI2LOH54Z
Odacite Color Balm - Sienna RoseZINC OXIDEOdacite52ba7f12-2b79-79cf-e063-6294a90a92d82026-05-26WarningsExact identifier
unii: SOI2LOH54Z
O HUI DAY SHIELD PERFECT SUN BLACK BROAD SPECTRUM SPF 50 SUNSCREENOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDELG H&H Co., Ltd.52ba9423-8b9b-38f7-e063-6394a90a95da2026-05-26WarningsExact identifier
unii: SOI2LOH54Z
unii: 15FIX9V2JP
Odacite Color Balm - Frosted PetalZINC OXIDEOdacite52ba9423-8b9d-38f7-e063-6394a90a95da2026-05-26WarningsExact identifier
unii: SOI2LOH54Z
Iris and Romeo Weekend Skin Moisture Lip Balm - DawnZINC OXIDEIris and Romeo52bb700b-ff56-2286-e063-6394a90ac4582026-05-26WarningsExact identifier
unii: SOI2LOH54Z
Iris and Romeo Weekend Skin Moisture Lip Balm - CamelliaZINC OXIDEIris and Romeo52bb52ec-2cd7-f8cc-e063-6294a90aa61b2026-05-26WarningsExact identifier
unii: SOI2LOH54Z
Bubble Solar Mate Daily Mineral Sunscreen SPF 40ZINC OXIDEBubble Beauty, Inc.d2eca90f-9463-4d2f-975d-02f2802ded3e2026-05-26WarningsExact identifier
unii: SOI2LOH54Z
Plexus Sun Shield Hydrating Mineral Sunscreen SPF 30ZINC OXIDEPlexus Worldwide, LLC55c391fa-37c6-47a2-befd-12888eb5fc182026-05-26WarningsExact identifier
unii: SOI2LOH54Z
Iris and Romeo Weekend Skin Moisture Lip Balm - SuedeZINC OXIDEIris and Romeo52bb7505-a027-2533-e063-6294a90a25202026-05-26WarningsExact identifier
unii: SOI2LOH54Z
Iris and Romeo Weekend Skin Moisture Lip Balm - CarobZINC OXIDEIris and Romeo52bbe9da-37f8-b3ba-e063-6394a90a139e2026-05-26WarningsExact identifier
unii: SOI2LOH54Z

Reported adverse events (FAERS/openFDA)#

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