FDA.reportPublic FDA data

Softlips

Product NDC
10742-8512
11-digit product format
107428512
Labeler code
10742
Product ID
10742-8512_452cb5de-d416-eb90-e063-6294a90aee96
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
2000-04-20
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

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIMETHICONE20 mg/g
OCTINOXATE75 mg/g
OCTISALATE30 mg/g
OXYBENZONE30 mg/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
bececc42-1321-430a-80ef-438060fdcc86Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
10742-8512-12023-02-07Drug Facts - Softlips Cherry SPF 20
10742-8512-92023-02-07Drug Facts - Softlips Cherry SPF 20
10742-8512-12023-01-30Drug Facts - Softlips Cherry SPF 20
10742-8512-92023-01-30Drug Facts - Softlips Cherry SPF 20

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10742-8512-1SoftlipsCherry1 in 1 BLISTER PACKOINTMENT16
10742-8512-1SoftlipsCherry2 g in 1 TUBEOINTMENT26
10742-8512-9SoftlipsCherry2 g in 1 TUBEOINTMENT26
10742-8512-9SoftlipsCherry2 in 1 BLISTER PACKOINTMENT26

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIMETHICONEACTIVE INGREDIENT92RU3N3Y1OSOFTLIPS CHERRY (DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE) OINTMENT [THE MENTHOLATUM COMPANY]2
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD51SOFTLIPS CHERRY (DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE) OINTMENT [THE MENTHOLATUM COMPANY]2
OCTISALATEACTIVE INGREDIENT4X49Y0596WSOFTLIPS CHERRY (DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE) OINTMENT [THE MENTHOLATUM COMPANY]2
OXYBENZONEACTIVE INGREDIENT95OOS7VE0YSOFTLIPS CHERRY (DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE) OINTMENT [THE MENTHOLATUM COMPANY]2
DIMETHICONEACTIVE MOIETY92RU3N3Y1OSOFTLIPS CHERRY (DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE) OINTMENT [THE MENTHOLATUM COMPANY]2
OCTINOXATEACTIVE MOIETY4Y5P7MUD51SOFTLIPS CHERRY (DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE) OINTMENT [THE MENTHOLATUM COMPANY]2
OCTISALATEACTIVE MOIETY4X49Y0596WSOFTLIPS CHERRY (DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE) OINTMENT [THE MENTHOLATUM COMPANY]2
OXYBENZONEACTIVE MOIETY95OOS7VE0YSOFTLIPS CHERRY (DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE) OINTMENT [THE MENTHOLATUM COMPANY]2
ALPHA-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ1SOFTLIPS CHERRY (DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE) OINTMENT [THE MENTHOLATUM COMPANY]2
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KSOFTLIPS CHERRY (DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE) OINTMENT [THE MENTHOLATUM COMPANY]2
CERESININACTIVE INGREDIENTQ1LS2UJO3ASOFTLIPS CHERRY (DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE) OINTMENT [THE MENTHOLATUM COMPANY]2
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNSOFTLIPS CHERRY (DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE) OINTMENT [THE MENTHOLATUM COMPANY]2
ETHYLHEXYL PALMITATEINACTIVE INGREDIENT2865993309SOFTLIPS CHERRY (DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE) OINTMENT [THE MENTHOLATUM COMPANY]2
MENTHOLINACTIVE INGREDIENTL7T10EIP3ASOFTLIPS CHERRY (DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE) OINTMENT [THE MENTHOLATUM COMPANY]2
MYRISTYL ALCOHOLINACTIVE INGREDIENTV42034O9PUSOFTLIPS CHERRY (DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE) OINTMENT [THE MENTHOLATUM COMPANY]2
MYRISTYL LACTATEINACTIVE INGREDIENT1D822OC34XSOFTLIPS CHERRY (DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE) OINTMENT [THE MENTHOLATUM COMPANY]2
MYRISTYL LAURATEINACTIVE INGREDIENT58U0NZN2BTSOFTLIPS CHERRY (DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE) OINTMENT [THE MENTHOLATUM COMPANY]2
MYRISTYL MYRISTATEINACTIVE INGREDIENT4042ZC00DYSOFTLIPS CHERRY (DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE) OINTMENT [THE MENTHOLATUM COMPANY]2
PETROLATUMINACTIVE INGREDIENT4T6H12BN9USOFTLIPS CHERRY (DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE) OINTMENT [THE MENTHOLATUM COMPANY]2
SQUALANEINACTIVE INGREDIENTGW89575KF9SOFTLIPS CHERRY (DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE) OINTMENT [THE MENTHOLATUM COMPANY]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10742-8512SOFTLIPS CHERRY (DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE) OINTMENT [THE MENTHOLATUM COMPANY]5Current NDC, Legacy NDC, 4 package rows20241219_bececc42-1321-430a-80ef-438060fdcc86.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 361 · 7,213 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ultra Violette Sheen Screen Broad Spectrum Hydrating Lip Balm DuskSPF50Grace And Fire USA Inc.2735ab0f-5eec-04c5-e063-6394a90aa60e2026-10-01WarningsExact identifier
application number: M020
Ultra Violette Sheen Screen Broad Spectrum Hydrating Lip Balm BejewelledSPF50Grace And Fire USA Inc.274a0544-6c71-4d91-e063-6394a90a22472026-10-01WarningsExact identifier
application number: M020
TRILIPIDERM All-Body Moisture Retention SPF-30AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENETrilipid Research Institute, LLC7f34de0a-eeb3-4b71-9abd-53d03266d9932026-09-10WarningsExact identifier
application number: M020
Neutrogena Ultra Sheer Dry Touch Sunscreen Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLC6a43173f-41f9-4207-a0db-53bc8db6f4a42026-09-10WarningsExact identifier
application number: M020
Neutrogena Ultra Sheer Body Mist Sunscreen Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLCd69b4992-d7e6-4bd7-b144-0485e35818a62026-09-10WarningsExact identifier
application number: M020
Hydra Finish SPF 15HOMOSALATE, OCTINOXATEGuinot4047e8ec-834a-41e6-a144-5649a7718de42026-09-10WarningsExact identifier
application number: M020
HYDRA BEAUTE SPF 15AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENEGuinot806d1e18-a3fc-43df-a52a-a640902d08872026-09-10WarningsExact identifier
application number: M020
Pur Confort SPF 15AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENEGuinot2fe0656f-f924-48da-91bf-d6f3d98e8fd92026-09-10WarningsExact identifier
application number: M020
Neutrogena Ultra Sheer Body Mist Sunscreen Broad Spectrum SPF 45AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLC51f3d6ca-3189-4380-9afb-4259ba8782742026-09-10WarningsExact identifier
application number: M020
Sun Logic Creme Solaire Visage et corps SPF 30AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENEGuinotb0a95379-998a-4cda-bae7-63faf3d6f3c82026-09-10WarningsExact identifier
application number: M020
Sun Logic Lait Solaire Corps SPF 20AVOBENZONE, HOMOSALATE, OCTOCRYLENEGuinotd9d2cee0-9189-42d0-b1ab-78b97141b1282026-09-10WarningsExact identifier
application number: M020
SunscreenBROAD SPECTRUM SPF 301226 W AESTHETICS5b0ef395-a7dd-378e-e063-6394a90a5dce2026-09-09WarningsExact identifier
application number: M020
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30W Aesthetics5b0f2c8f-d6fa-5e25-e063-6394a90a084d2026-09-09WarningsExact identifier
application number: M020
Baloom 2% Panthenol Hydro Airy SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE. OCTOCRYLENEARSN KOREA5148b638-f8a4-fa8b-e063-6294a90ac2082026-09-08WarningsExact identifier
application number: M020
Double-Duty Face MoisturizerMOSITURIZING SUNSCREENJack Black, LLC672be406-e3a1-47b4-8ef6-ee2b62baae962026-09-08WarningsExact identifier
application number: M020
Intense Therapy Lip Balm Pineapple MintSUNSCREEN SKIN PROTECTANT LIP BALMJack Black, LLC0862534c-5f48-4f67-a3b8-0876a667556f2026-09-08WarningsExact identifier
application number: M020
Intense Therapy Lip Balm SPF25, Shea Butter and Vitamin ELIP BALM SPF25Jack Black, LLC88e8752d-1fbf-4e28-b79d-7c05ecdce8422026-09-08WarningsExact identifier
application number: M020
Jack Black Intense Lip Therapy SPF25, Natural Mint and Shea ButterLIP BALM SUNSCREENJack Black, LLCe8730127-2d8d-4b80-ab90-d2f136d9e5162026-09-08WarningsExact identifier
application number: M020
Jack Black Intense Therapy Lip Balm SPF25, Grapefruit and GingerLIP BALM SUNSCREENJack Black, LLCd961d22a-2125-41e9-94a3-5b53d12b320f2026-09-08WarningsExact identifier
application number: M020
Intense Therapy Lip Balm Asian PearSUNSCREEN SKIN PROTECTANT LIP BALMJack Black, LLCacace707-6671-4818-86f2-d9813792157a2026-09-08WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10742-8512-1107428512011 TUBE in 1 BLISTER PACK (10742-8512-1) / 2 g in 1 TUBE1 tube2000-04-200000-00-00NoNoCurrent
10742-8512-9107428512092 TUBE in 1 BLISTER PACK (10742-8512-9) / 2 g in 1 TUBE2 tube2000-04-200000-00-00NoNoCurrent