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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Dataset, Scope, Package NDC table
DatasetScopePackage NDC
excluded productproduct
excluded packagepackage10742-8476-3
excluded packagepackage10742-8476-2
excluded packagepackage10742-8476-1

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 UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
92RU3N3Y1OInternal UNII lookup
4Y5P7MUD51Internal UNII lookup
4X49Y0596WInternal UNII lookup
95OOS7VE0YInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
03062f13-270d-49cf-8939-2349f12e9cbaAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
10742-8476-12023-02-07Drug Facts - Softlips Watermelon
10742-8476-22023-02-07Drug Facts - Softlips Watermelon
10742-8476-32023-02-07Drug Facts - Softlips Watermelon
10742-8476-12022-07-29Drug Facts - Softlips Watermelon
10742-8476-22022-07-29Drug Facts - Softlips Watermelon
10742-8476-32022-07-29Drug 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

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 1 of 360 · 7,197 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
UV Skin Recovery SPF 50ZINC OXIDECP Skin Health Group, Inc.26d2683f-cfd5-50fd-e063-6394a90a75762026-08-06WarningsExact identifier
application number: M020
AVOBENZONE, HOMOSALATE, OCTISALATEAVOBENZONE, HOMOSALATE, OCTISALATETopco Associates LLC58636012-7e29-7206-e063-6394a90a83e92026-08-06Warnings, Adverse reactionsExact identifier
application number: M020
UV Skin Recovery SPF 50 Red CorrectingZINC OXIDECP Skin Health Group, Inc.26e63890-d1af-d171-e063-6394a90af8282026-08-06WarningsExact identifier
application number: M020
AVOBENZONE, HOMOSALATE, OCTISALATEAVOBENZONE, HOMOSALATE, OCTISALATETopco Associates LLC5864275d-a480-06f8-e063-6394a90aecab2026-08-06Warnings, Adverse reactionsExact identifier
application number: M020
Avebonzone, Homosalate, OctisalateAVEBONZONE, HOMOSALATE, OCTISALATETopco Associates LLC5864881c-c495-1f32-e063-6294a90a13042026-08-06Warnings, Adverse reactionsExact identifier
application number: M020
Elta MD UV Daily Peptide Lip Balm SPF 40ZINC OXIDECP Skin Health Group, Inc945538b5-5745-42cf-b610-0018ca2ec2542026-08-06WarningsExact identifier
application number: M020
Avebonzone, Homosalate, OctisalateAVEBONZONE, HOMOSALATE, OCTISALATETopco Associates LLC58653d79-8fff-f319-e063-6294a90af7a32026-08-06Warnings, Adverse reactionsExact identifier
application number: M020
Avebonzone, Homosalate, OctisalateAVEBONZONE, HOMOSALATE, OCTISALATETopco Associates LLC5865f0e5-14b2-c4bf-e063-6294a90a47102026-08-06Warnings, Adverse reactionsExact identifier
application number: M020
EltaMD UV RestoreTITANIUM DIOXIDE, ZINC OXIDE SUNSCREENCP Skin Health Group, Inc37fee381-ce6b-4949-9a4a-778aa839fb842026-08-06WarningsExact identifier
application number: M020
Neutrogena MoistureShine Lip Soother with Sunscreen SPF 20, Shine 30AVOBENZONE, HOMOSALATE, OCTOCRYLENEKenvue Brands LLC129ae274-0094-be5e-e063-6394a90a98012026-08-05WarningsExact identifier
application number: M020
HERA UV PROTECTOR INVISIBLE SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEOTCM584c371c-24e3-5f9c-e063-6294a90a01bc2026-08-05WarningsExact identifier
application number: M020
Leader Kids Sport Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECARDINAL HEALTH 110, LLC. DBA LEADER3636693a-ba81-5d49-e063-6394a90a30062026-08-05WarningsExact identifier
application number: M020
Ceile tint PROTECT tinted serum SPF 50 IvoryCEILE TINT PROTECT TINTED SERUM SPF 50 IVORYLE COSMETICS INC58547809-3480-1032-e063-6294a90a04c62026-08-05WarningsExact identifier
application number: M020
Ceile tint PROTECT tinted serum SPF 50 Medium DeepCEILE TINT PROTECT TINTED SERUM SPF 50 MEDIUM DEEPLE COSMETICS INC58549160-3594-9056-e063-6394a90abf7d2026-08-05WarningsExact identifier
application number: M020
Ceile tint PROTECT tinted serum SPF 50 DeepCEILE TINT PROTECT TINTED SERUM SPF 50 DEEPLE COSMETICS INC585498d4-b29c-9580-e063-6394a90adf1e2026-08-05WarningsExact identifier
application number: M020
Ceile tint PROTECT tinted serum SPF 50 FairCEILE TINT PROTECT TINTED SERUM SPF 50 FAIRLE COSMETICS INC58545633-cb36-6611-e063-6394a90a1f072026-08-05WarningsExact identifier
application number: M020
Ceile tint PROTECT tinted serum SPF 50 LightCEILE TINT PROTECT TINTED SERUM SPF 50 LIGHTLE COSMETICS INC5853ae6b-0eaf-e614-e063-6394a90ae91a2026-08-05WarningsExact identifier
application number: M020
Ceile tint PROTECT tinted serum SPF 50 Light MediumCEILE TINT PROTECT TINTED SERUM SPF 50 LIGHT MEDIUMLE COSMETICS INC585473c3-3ee9-7d84-e063-6394a90abd332026-08-05WarningsExact identifier
application number: M020
Ceile tint PROTECT tinted serum SPF 50 MediumCEILE TINT PROTECT TINTED SERUM SPF 50 MEDIUMLE COSMETICS INC58547b48-251a-10eb-e063-6294a90ac95c2026-08-05WarningsExact identifier
application number: M020
Ceile tint PROTECT tinted serum SPF 50 Medium TanCEILE TINT PROTECT TINTED SERUM SPF 50 MEDIUM TANLE COSMETICS INC58547e38-ae84-82ee-e063-6394a90a27d62026-08-05WarningsExact identifier
application number: M020

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