FDA.reportPublic FDA data

Softlips

Product NDC
10742-8476
11-digit product format
107428476
Labeler code
10742
Product ID
10742-8476_2979a53f-be08-612d-e063-6294a90acdda
Type
HUMAN OTC DRUG
Nonproprietary name
dimethicone, octinoxate, octisalate, oxybenzone
Dosage form
STICK
Route
TOPICAL
Labeler
The Mentholatum Company
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-04-16
Substance
DIMETHICONE; OCTINOXATE; OCTISALATE; OXYBENZONE
Active strength
20; 75; 30; 30 mg/g; mg/g; mg/g; ug/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
Watermelon
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized Identifiers#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10742-8476-12023-02-07C16284748780-1e4f33bdf-ae0d-d8a0-e053-dadaa90a6e4eDrug Facts - Softlips Watermelon
10742-8476-22023-02-07C16284748780-1e4f33bdf-ae0d-d8a0-e053-dadaa90a6e4eDrug Facts - Softlips Watermelon
10742-8476-32023-02-07C16284748780-1e4f33bdf-ae0d-d8a0-e053-dadaa90a6e4eDrug Facts - Softlips Watermelon
10742-8476-12022-07-29C16284748780-1e4f33bdf-ae0d-d8a0-e053-dadaa90a6e4eDrug Facts - Softlips Watermelon
10742-8476-22022-07-29C16284748780-1e4f33bdf-ae0d-d8a0-e053-dadaa90a6e4eDrug Facts - Softlips Watermelon
10742-8476-32022-07-29C16284748780-1e4f33bdf-ae0d-d8a0-e053-dadaa90a6e4eDrug Facts - Softlips Watermelon

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10742-8476-1SoftlipsWatermelon1 in 1 BLISTER PACKSTICK16
10742-8476-1SoftlipsWatermelon2 g in 1 TUBESTICK26
10742-8476-2SoftlipsWatermelon2 in 1 BLISTER PACKSTICK26
10742-8476-2SoftlipsWatermelon2 g in 1 TUBESTICK26
10742-8476-3SoftlipsWatermelon3 in 1 BLISTER PACKSTICK36
10742-8476-3SoftlipsWatermelon2 g in 1 TUBESTICK26

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIMETHICONEACTIVE INGREDIENT92RU3N3Y1OSOFTLIPS WATERMELON (DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE) STICK [THE MENTHOLATUM COMPANY]1
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD51SOFTLIPS WATERMELON (DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE) STICK [THE MENTHOLATUM COMPANY]1
OCTISALATEACTIVE INGREDIENT4X49Y0596WSOFTLIPS WATERMELON (DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE) STICK [THE MENTHOLATUM COMPANY]1
OXYBENZONEACTIVE INGREDIENT95OOS7VE0YSOFTLIPS WATERMELON (DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE) STICK [THE MENTHOLATUM COMPANY]1
DIMETHICONEACTIVE MOIETY92RU3N3Y1OSOFTLIPS WATERMELON (DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE) STICK [THE MENTHOLATUM COMPANY]1
OCTINOXATEACTIVE MOIETY4Y5P7MUD51SOFTLIPS WATERMELON (DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE) STICK [THE MENTHOLATUM COMPANY]1
OCTISALATEACTIVE MOIETY4X49Y0596WSOFTLIPS WATERMELON (DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE) STICK [THE MENTHOLATUM COMPANY]1
OXYBENZONEACTIVE MOIETY95OOS7VE0YSOFTLIPS WATERMELON (DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE) STICK [THE MENTHOLATUM COMPANY]1
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0SOFTLIPS WATERMELON (DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE) STICK [THE MENTHOLATUM COMPANY]1
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KSOFTLIPS WATERMELON (DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE) STICK [THE MENTHOLATUM COMPANY]1
CERESININACTIVE INGREDIENTQ1LS2UJO3ASOFTLIPS WATERMELON (DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE) STICK [THE MENTHOLATUM COMPANY]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNSOFTLIPS WATERMELON (DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE) STICK [THE MENTHOLATUM COMPANY]1
ETHYLHEXYL PALMITATEINACTIVE INGREDIENT2865993309SOFTLIPS WATERMELON (DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE) STICK [THE MENTHOLATUM COMPANY]1
MENTHOLINACTIVE INGREDIENTL7T10EIP3ASOFTLIPS WATERMELON (DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE) STICK [THE MENTHOLATUM COMPANY]1
MYRISTYL ALCOHOLINACTIVE INGREDIENTV42034O9PUSOFTLIPS WATERMELON (DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE) STICK [THE MENTHOLATUM COMPANY]1
MYRISTYL LACTATEINACTIVE INGREDIENT1D822OC34XSOFTLIPS WATERMELON (DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE) STICK [THE MENTHOLATUM COMPANY]1
MYRISTYL LAURATEINACTIVE INGREDIENT58U0NZN2BTSOFTLIPS WATERMELON (DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE) STICK [THE MENTHOLATUM COMPANY]1
MYRISTYL MYRISTATEINACTIVE INGREDIENT4042ZC00DYSOFTLIPS WATERMELON (DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE) STICK [THE MENTHOLATUM COMPANY]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9USOFTLIPS WATERMELON (DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE) STICK [THE MENTHOLATUM COMPANY]1
SQUALANEINACTIVE INGREDIENTGW89575KF9SOFTLIPS WATERMELON (DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE) STICK [THE MENTHOLATUM COMPANY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10742-8476SOFTLIPS WATERMELON (DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE) STICK [THE MENTHOLATUM COMPANY]6Current NDC, Legacy NDC, 6 package rows20241219_03062f13-270d-49cf-8939-2349f12e9cba.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10742-8476-1107428476011 TUBE in 1 BLISTER PACK (10742-8476-1) / 2 g in 1 TUBE1 tube2012-04-160000-00-00NoNoCurrent
10742-8476-2107428476022 TUBE in 1 BLISTER PACK (10742-8476-2) / 2 g in 1 TUBE2 tube2016-12-010000-00-00NoNoCurrent
10742-8476-3107428476033 TUBE in 1 BLISTER PACK (10742-8476-3) / 2 g in 1 TUBE3 tube2020-04-060000-00-00NoNoCurrent