Softlips

Product NDC
10742-8476
Requested package NDC
10742-8476-2
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 · 1 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage10742-847610742-8476-2IInactivated by FDAexcluded / ndc_excluded.zipfb8cb913e6d1…eb8c232b6be0…

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#

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 359 · 7,165 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NeoStrata Skin Active Matrix Support SPF 30AVOBENZONE, OCTINOXATE, AND OCTISALATENeoStrata Company Inc.8e4b9c08-b906-4c5f-a243-55838ae28b902026-07-29WarningsExact identifier
application number: M020
Exuviance Age Reverse Day Repair with Sunscreen Broad Spectrum SPF 30AVOBENZONE, OCTINOXATE, AND OCTISALATENeoStrata Company Inc.4739e678-ce51-4863-bb74-2275879e1b472026-07-29WarningsExact identifier
application number: M020
MELAO GHK-Cu PEPTIDE SUNSCREENBUTYL METHOXYDIBENZOYLMETHANE,ETHYLHEXYL SALICYLATE,HOMOSALATE,OCTOCRYLENEGuangdong Aimu Biological Technology Co., Ltd57a8c34a-d6c9-c03e-e063-6394a90a7af12026-07-29WarningsExact identifier
application number: M020
BelleJoss BROAD SPECTRUM SPF 50BROAD SPECTRUM SPF 50Guangzhou Liyan Cosmetics Technology Co., Ltd.57c07f29-2e23-d18a-e063-6394a90a10202026-07-29WarningsExact identifier
application number: M020
BemeJolie BROAD SPECTRUM SPF 50BROAD SPECTRUM SPF 50Guangzhou Liyan Cosmetics Technology Co., Ltd.57c27cea-bb0c-5d2d-e063-6394a90a1b482026-07-29WarningsExact identifier
application number: M020
Native Mineral Suncare Broad Spectrum SPF 30 UnscentedZINC OXIDEThe Procter & Gamble Manufacturing Company3a89238b-d1ee-d7fa-e063-6294a90ae55f2026-07-28WarningsExact identifier
application number: M020
First Aid Beauty FAB Mineral Sunscreen Broad Spectrum SPF 30ZINC OXIDEThe Procter & Gamble Manufacturing Companydfb1b42e-c821-1a41-e053-2995a90acf952026-07-28WarningsExact identifier
application number: M020
LUXE COLOR FOUNDATIONOCTINOXATE 7% ZINC OXIDE 5%Guangzhou Huixue Biotechnology Co., Ltd.576c3496-702f-808c-e063-6394a90a53c32026-07-25WarningsExact identifier
application number: M020
No7 Restore and Renew Multi Action Day Cream Sunscreen Broad Spectrum SPF 25 KitAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENEXact Packing Limited5759058d-e683-f3fc-e063-6394a90abc012026-07-24WarningsExact identifier
application number: M020
Younique Bare You BB Tinted Moisturizer Sunscreen Broad Spectrum SPF-30 LIGHTZINC OXIDEYounique, LLCf93d42a9-b655-4b75-a16d-b29f38f04efc2026-07-23WarningsExact identifier
application number: M020
Younique Bare You BB Tinted Moisturizer Sunscreen Broad Spectrum SPF-30 LIGHT MEDIUMZINC OXIDEYounique, LLC82769819-b229-4864-9b3c-44f49a68a53a2026-07-23WarningsExact identifier
application number: M020
Younique Bare You BB Tinted Moisturizer Sunscreen Broad Spectrum SPF-30 FAIRZINC OXIDEYounique, LLCed700cae-8226-48d9-93ba-03154aa1cae52026-07-23WarningsExact identifier
application number: M020
Younique Bare You BB Tinted Moisturizer Sunscreen Broad Spectrum SPF-30 FAIR LIGHTZINC OXIDEYounique, LLCd728b89c-692f-485b-88c3-929b2f0350d52026-07-23WarningsExact identifier
application number: M020
Younique Bare You BB Tinted Moisturizer Sunscreen Broad Spectrum SPF-30 MEDIUMZINC OXIDEYounique, LLCa49dfff1-e9ec-4573-90b0-ef6a7226aa562026-07-23WarningsExact identifier
application number: M020
Younique Bare You BB Tinted Moisturizer Sunscreen Broad Spectrum SPF-30 MEDIUM DARKZINC OXIDEYounique, LLCcc576b63-caf4-491d-8d7f-027b1127133b2026-07-23WarningsExact identifier
application number: M020
Younique Bare You BB Tinted Moisturizer Sunscreen Broad Spectrum SPF-30 DARKZINC OXIDEYounique, LLC2173666b-6c72-449d-9f40-098ea174f3e12026-07-23WarningsExact identifier
application number: M020
Younique Bare You BB Tinted Moisturizer Sunscreen Broad Spectrum SPF-30 DARK DEEPZINC OXIDEYounique, LLC360ceb90-bec6-4fec-820a-a4d65008b8722026-07-23WarningsExact identifier
application number: M020
Younique Bare You BB Tinted Moisturizer Sunscreen Broad Spectrum SPF-30 DEEPZINC OXIDEYounique, LLC86c33a9e-9132-4377-8688-41e5844de62c2026-07-23WarningsExact identifier
application number: M020
MENOKIN 30 SECONDS GLOW AND CLEAR Gel SUNSCREEN MOISTUREAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEForest Avenue Co., Ltd.edbfcf21-96c6-4519-8b08-f9b5ada7d1d72026-07-23WarningsExact identifier
application number: M020
SKINSUIT LIP SPF 30ZINC OXIDESkin Authority LLCcb24d714-f6cd-4518-b146-627cfe6c2ccd2026-07-23WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10742-8476-2107428476022 TUBE in 1 BLISTER PACK (10742-8476-2) / 2 g in 1 TUBE2 tube2016-12-010000-00-00NoNoCurrent