TENDERTONE LIP BALM SPF 12

Product NDC
40046-0030
11-digit product format
400460030
Labeler code
40046
Product ID
40046-0030_55e576e5-b615-429a-90f5-f741d3d48209
Type
HUMAN OTC DRUG
Nonproprietary name
OCTINOXATE, OCTISALATE, and AVOBENZONE
Dosage form
LIPSTICK
Route
TOPICAL
Labeler
MAKEUP ART COSMETICS
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2007-01-01
Marketing end
0000-00-00
Substance
OCTINOXATE; OCTISALATE; AVOBENZONE
Active strength
8 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
95250459-30e4-45c1-b08a-993044f49109Product name220250805
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
40046-0030-12019-11-13C16284748780-197449f38-c0d1-f6ea-e053-dbdaa90aa703MAC TENDERTONE LIP BALM SPF 12

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
40046-0030-1TENDERTONE LIP BALM SPF 121 in 1 CARTONLIPSTICK11
40046-0030-1TENDERTONE LIP BALM SPF 126 mL in 1 JARLIPSTICK61

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOXTENDERTONE LIP BALM SPF 12 (OCTINOXATE, OCTISALATE, AND AVOBENZONE) LIPSTICK [MAKEUP ART COSMETICS]1
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD51TENDERTONE LIP BALM SPF 12 (OCTINOXATE, OCTISALATE, AND AVOBENZONE) LIPSTICK [MAKEUP ART COSMETICS]1
OCTISALATEACTIVE INGREDIENT4X49Y0596WTENDERTONE LIP BALM SPF 12 (OCTINOXATE, OCTISALATE, AND AVOBENZONE) LIPSTICK [MAKEUP ART COSMETICS]1
AVOBENZONEACTIVE MOIETYG63QQF2NOXTENDERTONE LIP BALM SPF 12 (OCTINOXATE, OCTISALATE, AND AVOBENZONE) LIPSTICK [MAKEUP ART COSMETICS]1
OCTINOXATEACTIVE MOIETY4Y5P7MUD51TENDERTONE LIP BALM SPF 12 (OCTINOXATE, OCTISALATE, AND AVOBENZONE) LIPSTICK [MAKEUP ART COSMETICS]1
OCTISALATEACTIVE MOIETY4X49Y0596WTENDERTONE LIP BALM SPF 12 (OCTINOXATE, OCTISALATE, AND AVOBENZONE) LIPSTICK [MAKEUP ART COSMETICS]1
Alpha-Tocopherol AcetateINACTIVE INGREDIENT9E8X80D2L0TENDERTONE LIP BALM SPF 12 (OCTINOXATE, OCTISALATE, AND AVOBENZONE) LIPSTICK [MAKEUP ART COSMETICS]1
Aluminum OxideINACTIVE INGREDIENTLMI26O6933TENDERTONE LIP BALM SPF 12 (OCTINOXATE, OCTISALATE, AND AVOBENZONE) LIPSTICK [MAKEUP ART COSMETICS]1
Arabica Coffee BeanINACTIVE INGREDIENT3SW678MX72TENDERTONE LIP BALM SPF 12 (OCTINOXATE, OCTISALATE, AND AVOBENZONE) LIPSTICK [MAKEUP ART COSMETICS]1
Astrocaryum Murumuru Seed ButterINACTIVE INGREDIENT12V64UPU6RTENDERTONE LIP BALM SPF 12 (OCTINOXATE, OCTISALATE, AND AVOBENZONE) LIPSTICK [MAKEUP ART COSMETICS]1
Bismuth OxychlorideINACTIVE INGREDIENT4ZR792I587TENDERTONE LIP BALM SPF 12 (OCTINOXATE, OCTISALATE, AND AVOBENZONE) LIPSTICK [MAKEUP ART COSMETICS]1
Black OliveINACTIVE INGREDIENT2M6QWV94OCTENDERTONE LIP BALM SPF 12 (OCTINOXATE, OCTISALATE, AND AVOBENZONE) LIPSTICK [MAKEUP ART COSMETICS]1
Butylated HydroxytolueneINACTIVE INGREDIENT1P9D0Z171KTENDERTONE LIP BALM SPF 12 (OCTINOXATE, OCTISALATE, AND AVOBENZONE) LIPSTICK [MAKEUP ART COSMETICS]1
Caprylyl GlycolINACTIVE INGREDIENT00YIU5438UTENDERTONE LIP BALM SPF 12 (OCTINOXATE, OCTISALATE, AND AVOBENZONE) LIPSTICK [MAKEUP ART COSMETICS]1
CholesterolINACTIVE INGREDIENT97C5T2UQ7JTENDERTONE LIP BALM SPF 12 (OCTINOXATE, OCTISALATE, AND AVOBENZONE) LIPSTICK [MAKEUP ART COSMETICS]1
CochinealINACTIVE INGREDIENTTZ8Z31B35MTENDERTONE LIP BALM SPF 12 (OCTINOXATE, OCTISALATE, AND AVOBENZONE) LIPSTICK [MAKEUP ART COSMETICS]1
D&C Red No. 28INACTIVE INGREDIENT767IP0Y5NHTENDERTONE LIP BALM SPF 12 (OCTINOXATE, OCTISALATE, AND AVOBENZONE) LIPSTICK [MAKEUP ART COSMETICS]1
D&C Red No. 30INACTIVE INGREDIENT2S42T2808BTENDERTONE LIP BALM SPF 12 (OCTINOXATE, OCTISALATE, AND AVOBENZONE) LIPSTICK [MAKEUP ART COSMETICS]1
D&C Red No. 33INACTIVE INGREDIENT9DBA0SBB0LTENDERTONE LIP BALM SPF 12 (OCTINOXATE, OCTISALATE, AND AVOBENZONE) LIPSTICK [MAKEUP ART COSMETICS]1
D&C Red No. 6INACTIVE INGREDIENT481744AI4OTENDERTONE LIP BALM SPF 12 (OCTINOXATE, OCTISALATE, AND AVOBENZONE) LIPSTICK [MAKEUP ART COSMETICS]1
D&C Red No. 7INACTIVE INGREDIENTECW0LZ41X8TENDERTONE LIP BALM SPF 12 (OCTINOXATE, OCTISALATE, AND AVOBENZONE) LIPSTICK [MAKEUP ART COSMETICS]1
D&C Yellow No. 10INACTIVE INGREDIENT35SW5USQ3GTENDERTONE LIP BALM SPF 12 (OCTINOXATE, OCTISALATE, AND AVOBENZONE) LIPSTICK [MAKEUP ART COSMETICS]1
EthylcellulosesINACTIVE INGREDIENT7Z8S9VYZ4BTENDERTONE LIP BALM SPF 12 (OCTINOXATE, OCTISALATE, AND AVOBENZONE) LIPSTICK [MAKEUP ART COSMETICS]1
FD&C Blue No. 1INACTIVE INGREDIENTH3R47K3TBDTENDERTONE LIP BALM SPF 12 (OCTINOXATE, OCTISALATE, AND AVOBENZONE) LIPSTICK [MAKEUP ART COSMETICS]1
FD&C Yellow No. 5INACTIVE INGREDIENTI753WB2F1MTENDERTONE LIP BALM SPF 12 (OCTINOXATE, OCTISALATE, AND AVOBENZONE) LIPSTICK [MAKEUP ART COSMETICS]1
Ferric Oxide RedINACTIVE INGREDIENT1K09F3G675TENDERTONE LIP BALM SPF 12 (OCTINOXATE, OCTISALATE, AND AVOBENZONE) LIPSTICK [MAKEUP ART COSMETICS]1
Ferric Oxide YellowINACTIVE INGREDIENTEX438O2MRTTENDERTONE LIP BALM SPF 12 (OCTINOXATE, OCTISALATE, AND AVOBENZONE) LIPSTICK [MAKEUP ART COSMETICS]1
Ferrosoferric OxideINACTIVE INGREDIENTXM0M87F357TENDERTONE LIP BALM SPF 12 (OCTINOXATE, OCTISALATE, AND AVOBENZONE) LIPSTICK [MAKEUP ART COSMETICS]1
Glyceryl MonostearateINACTIVE INGREDIENT230OU9XXE4TENDERTONE LIP BALM SPF 12 (OCTINOXATE, OCTISALATE, AND AVOBENZONE) LIPSTICK [MAKEUP ART COSMETICS]1
Hexylene GlycolINACTIVE INGREDIENTKEH0A3F75JTENDERTONE LIP BALM SPF 12 (OCTINOXATE, OCTISALATE, AND AVOBENZONE) LIPSTICK [MAKEUP ART COSMETICS]1
Linoleic AcidINACTIVE INGREDIENT9KJL21T0QJTENDERTONE LIP BALM SPF 12 (OCTINOXATE, OCTISALATE, AND AVOBENZONE) LIPSTICK [MAKEUP ART COSMETICS]1
MicaINACTIVE INGREDIENTV8A1AW0880TENDERTONE LIP BALM SPF 12 (OCTINOXATE, OCTISALATE, AND AVOBENZONE) LIPSTICK [MAKEUP ART COSMETICS]1
OctyldodecanolINACTIVE INGREDIENT461N1O614YTENDERTONE LIP BALM SPF 12 (OCTINOXATE, OCTISALATE, AND AVOBENZONE) LIPSTICK [MAKEUP ART COSMETICS]1
Oleic AcidINACTIVE INGREDIENT2UMI9U37CPTENDERTONE LIP BALM SPF 12 (OCTINOXATE, OCTISALATE, AND AVOBENZONE) LIPSTICK [MAKEUP ART COSMETICS]1
Palmitic AcidINACTIVE INGREDIENT2V16EO95H1TENDERTONE LIP BALM SPF 12 (OCTINOXATE, OCTISALATE, AND AVOBENZONE) LIPSTICK [MAKEUP ART COSMETICS]1
PetrolatumINACTIVE INGREDIENT4T6H12BN9UTENDERTONE LIP BALM SPF 12 (OCTINOXATE, OCTISALATE, AND AVOBENZONE) LIPSTICK [MAKEUP ART COSMETICS]1
PhenoxyethanolINACTIVE INGREDIENTHIE492ZZ3TTENDERTONE LIP BALM SPF 12 (OCTINOXATE, OCTISALATE, AND AVOBENZONE) LIPSTICK [MAKEUP ART COSMETICS]1
Potassium SulfateINACTIVE INGREDIENT1K573LC5TVTENDERTONE LIP BALM SPF 12 (OCTINOXATE, OCTISALATE, AND AVOBENZONE) LIPSTICK [MAKEUP ART COSMETICS]1
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4TENDERTONE LIP BALM SPF 12 (OCTINOXATE, OCTISALATE, AND AVOBENZONE) LIPSTICK [MAKEUP ART COSMETICS]1
Stannic OxideINACTIVE INGREDIENTKM7N50LOS6TENDERTONE LIP BALM SPF 12 (OCTINOXATE, OCTISALATE, AND AVOBENZONE) LIPSTICK [MAKEUP ART COSMETICS]1
Titanium DioxideINACTIVE INGREDIENT15FIX9V2JPTENDERTONE LIP BALM SPF 12 (OCTINOXATE, OCTISALATE, AND AVOBENZONE) LIPSTICK [MAKEUP ART COSMETICS]1
WaterINACTIVE INGREDIENT059QF0KO0RTENDERTONE LIP BALM SPF 12 (OCTINOXATE, OCTISALATE, AND AVOBENZONE) LIPSTICK [MAKEUP ART COSMETICS]1
Wheat BranINACTIVE INGREDIENT6L966A1IMRTENDERTONE LIP BALM SPF 12 (OCTINOXATE, OCTISALATE, AND AVOBENZONE) LIPSTICK [MAKEUP ART COSMETICS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
40046-0030TENDERTONE LIP BALM SPF 12 (OCTINOXATE, OCTISALATE, AND AVOBENZONE) LIPSTICK [MAKEUP ART COSMETICS]1Legacy NDC, 2 package rows20120118_f75ccb8e-9947-4921-9dc7-20816dee7372.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
40046-0030-1400460030011 in 1 CARTONHistorical