FDA.reportPublic FDA data

Softlips

Product NDC
10742-8470
11-digit product format
107428470
Labeler code
10742
Product ID
10742-8470_2979a2c2-faed-ac85-e063-6294a90a3dc5
Type
HUMAN OTC DRUG
Nonproprietary name
dimethicone, octinoxate, octisalate, oxybenzone
Dosage form
OINTMENT
Route
TOPICAL
Labeler
The Mentholatum Company
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2007-01-12
Substance
DIMETHICONE; OCTINOXATE; OCTISALATE; OXYBENZONE
Active strength
20; 75; 30; 30 mg/g; mg/g; mg/g; mg/g
Pharmacologic classes
Skin Barrier Activity [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Softlips
Brand name suffix
Raspberry
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIMETHICONE20 mg/g
OCTINOXATE75 mg/g
OCTISALATE30 mg/g
OXYBENZONE30 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii92RU3N3Y1O, 4Y5P7MUD51, 4X49Y0596W, 95OOS7VE0Y

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10742-8470-12023-02-07C16284748780-1f386c649-ba13-0266-e053-dadaa90a7c1aDrug Facts - Softlips Raspberry
10742-8470-92023-02-07C16284748780-1f386c649-ba13-0266-e053-dadaa90a7c1aDrug Facts - Softlips Raspberry
10742-8470-12023-01-30C16284748780-1f386c649-ba13-0266-e053-dadaa90a7c1aDrug Facts - Softlips Raspberry
10742-8470-92023-01-30C16284748780-1f386c649-ba13-0266-e053-dadaa90a7c1aDrug Facts - Softlips Raspberry

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10742-8470-1SoftlipsRaspberry2 g in 1 TUBEOINTMENT25
10742-8470-1SoftlipsRaspberry1 in 1 BLISTER PACKOINTMENT15
10742-8470-9SoftlipsRaspberry2 g in 1 TUBEOINTMENT25
10742-8470-9SoftlipsRaspberry2 in 1 BLISTER PACKOINTMENT25

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIMETHICONEACTIVE INGREDIENT92RU3N3Y1OSOFTLIPS RASPBERRY (DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE) OINTMENT [THE MENTHOLATUM COMPANY]2
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD51SOFTLIPS RASPBERRY (DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE) OINTMENT [THE MENTHOLATUM COMPANY]2
OCTISALATEACTIVE INGREDIENT4X49Y0596WSOFTLIPS RASPBERRY (DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE) OINTMENT [THE MENTHOLATUM COMPANY]2
OXYBENZONEACTIVE INGREDIENT95OOS7VE0YSOFTLIPS RASPBERRY (DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE) OINTMENT [THE MENTHOLATUM COMPANY]2
DIMETHICONEACTIVE MOIETY92RU3N3Y1OSOFTLIPS RASPBERRY (DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE) OINTMENT [THE MENTHOLATUM COMPANY]2
OCTINOXATEACTIVE MOIETY4Y5P7MUD51SOFTLIPS RASPBERRY (DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE) OINTMENT [THE MENTHOLATUM COMPANY]2
OCTISALATEACTIVE MOIETY4X49Y0596WSOFTLIPS RASPBERRY (DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE) OINTMENT [THE MENTHOLATUM COMPANY]2
OXYBENZONEACTIVE MOIETY95OOS7VE0YSOFTLIPS RASPBERRY (DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE) OINTMENT [THE MENTHOLATUM COMPANY]2
ALPHA-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ1SOFTLIPS RASPBERRY (DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE) OINTMENT [THE MENTHOLATUM COMPANY]2
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KSOFTLIPS RASPBERRY (DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE) OINTMENT [THE MENTHOLATUM COMPANY]2
CAMELLIA OLEIFERA LEAFINACTIVE INGREDIENT5077EL0C60SOFTLIPS RASPBERRY (DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE) OINTMENT [THE MENTHOLATUM COMPANY]2
CASTOR OILINACTIVE INGREDIENTD5340Y2I9GSOFTLIPS RASPBERRY (DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE) OINTMENT [THE MENTHOLATUM COMPANY]2
CERESININACTIVE INGREDIENTQ1LS2UJO3ASOFTLIPS RASPBERRY (DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE) OINTMENT [THE MENTHOLATUM COMPANY]2
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNSOFTLIPS RASPBERRY (DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE) OINTMENT [THE MENTHOLATUM COMPANY]2
ETHYLHEXYL PALMITATEINACTIVE INGREDIENT2865993309SOFTLIPS RASPBERRY (DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE) OINTMENT [THE MENTHOLATUM COMPANY]2
EVENING PRIMROSE OILINACTIVE INGREDIENT3Q9L08K71NSOFTLIPS RASPBERRY (DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE) OINTMENT [THE MENTHOLATUM COMPANY]2
MENTHOLINACTIVE INGREDIENTL7T10EIP3ASOFTLIPS RASPBERRY (DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE) OINTMENT [THE MENTHOLATUM COMPANY]2
MYRISTYL ALCOHOLINACTIVE INGREDIENTV42034O9PUSOFTLIPS RASPBERRY (DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE) OINTMENT [THE MENTHOLATUM COMPANY]2
MYRISTYL LACTATEINACTIVE INGREDIENT1D822OC34XSOFTLIPS RASPBERRY (DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE) OINTMENT [THE MENTHOLATUM COMPANY]2
MYRISTYL LAURATEINACTIVE INGREDIENT58U0NZN2BTSOFTLIPS RASPBERRY (DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE) OINTMENT [THE MENTHOLATUM COMPANY]2
MYRISTYL MYRISTATEINACTIVE INGREDIENT4042ZC00DYSOFTLIPS RASPBERRY (DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE) OINTMENT [THE MENTHOLATUM COMPANY]2
PETROLATUMINACTIVE INGREDIENT4T6H12BN9USOFTLIPS RASPBERRY (DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE) OINTMENT [THE MENTHOLATUM COMPANY]2
POMEGRANATEINACTIVE INGREDIENT56687D1Z4DSOFTLIPS RASPBERRY (DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE) OINTMENT [THE MENTHOLATUM COMPANY]2
SAFFLOWER OILINACTIVE INGREDIENT65UEH262ISSOFTLIPS RASPBERRY (DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE) OINTMENT [THE MENTHOLATUM COMPANY]2
SQUALANEINACTIVE INGREDIENTGW89575KF9SOFTLIPS RASPBERRY (DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE) OINTMENT [THE MENTHOLATUM COMPANY]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10742-8470SOFTLIPS RASPBERRY (DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE) OINTMENT [THE MENTHOLATUM COMPANY]5Current NDC, Legacy NDC, 4 package rows20241219_d18b4c19-0365-44ec-bea8-4328e537e0d8.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10742-8470-1107428470011 TUBE in 1 BLISTER PACK (10742-8470-1) / 2 g in 1 TUBE1 tube2007-01-120000-00-00NoNoCurrent
10742-8470-9107428470092 TUBE in 1 BLISTER PACK (10742-8470-9) / 2 g in 1 TUBE2 tube2007-01-120000-00-00NoNoCurrent