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

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 · 7,202 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ISNTREE HYALURONIC ACID SENSITIVE SUNSCREENZINC OXIDEISNTREE Inc.58e38665-0bca-fb02-e063-6394a90ad62a2026-08-13WarningsExact identifier
application number: M020
Neutrogena Ultra Sheer Daily Face Sunscreen Broad Spectrum SPF 70AVOBENZONE, BEMOTRIZINOL, HOMOSALATE, OCTISALATEKenvue Brands LLC58d3d390-8b88-a6fe-e063-6394a90a9bf82026-08-12WarningsExact identifier
application number: M020
Neutrogena Clear Face Sunscreen Acne Prone Skin Broad Spectrum SPF 60AVOBENZONE, BEMOTRIZINOL, HOMOSALATE, OCTISALATEKenvue Brands LLC58d7a3e3-b7df-43ce-e063-6294a90a729c2026-08-12WarningsExact identifier
application number: M020
Elta MD Skincare UV Stick Broad Spectrum SPF50ZINC OXIDECP Skin Health Group, Inc58dd81db-46d4-d763-e063-6394a90abb0b2026-08-12WarningsExact identifier
application number: M020
UV Skin Recovery SPF 50 Red CorrectingZINC OXIDECP Skin Health Group, Inc.26e63890-d1af-d171-e063-6394a90af8282026-08-12WarningsExact identifier
application number: M020
UV Skin Recovery SPF 50ZINC OXIDECP Skin Health Group, Inc.26d2683f-cfd5-50fd-e063-6394a90a75762026-08-12WarningsExact identifier
application number: M020
doTERRA Sun BodyMINERAL SUNSCREENdoTERRA International, LLC58dcc56f-f093-469c-e063-6394a90a60882026-08-12WarningsExact identifier
application number: M020
Colorescience Total Protection Body Shield GlowZINC OXIDEColorescience52e1d987-a4f8-195e-e063-6294a90a56292026-08-11WarningsExact identifier
application number: M020
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30DR. SAMRAO'S OFFICE58b2ca35-11ed-d848-e063-6294a90a5b372026-08-11WarningsExact identifier
application number: M020
Ciele Tint and ProtectZINC OXIDECiele0162d9c9-07fa-9210-e063-6294a90aa6872026-08-11WarningsExact identifier
application number: M020
NeoStrata Skin Active Matrix Support SPF 30AVOBENZONE, OCTINOXATE, AND OCTISALATENeoStrata Company Inc.8e4b9c08-b906-4c5f-a243-55838ae28b902026-08-10WarningsExact identifier
application number: M020
HEADHUNTER SURF SCREEN SPF 50 SUNSCREENZINC OXIDE,TITANIUM DIOXIDEGuangzhou Tata Biotechnology Co., Ltd.4339df13-77d3-31a1-e063-6394a90a52082026-08-10WarningsExact identifier
application number: M020
Sunscreen for Kids SPF 50AVOBENZONE, HOMOSALATE, OCTISALATEThe Kroger Co.1c7cd904-ffff-48aa-91bd-cc978946b36a2026-08-10Warnings, Adverse reactionsExact identifier
application number: M020
Sport Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATEThe Kroger Co.22aa46af-5d0f-4256-8f45-be06f66275612026-08-10WarningsExact identifier
application number: M020
Colorescience Total Protection No Show Mineral Body ShieldZINC OXIDEColorescience52e1f59e-63cb-7480-e063-6394a90ad7c52026-08-10WarningsExact identifier
application number: M020
Journee Firm Riche Broad Spectrum Sunscreen SPF 30TITANIUM DIOXIDE AND ZINC OXIDEMerz North America, Inc.d4d4bfcf-3674-4847-8ad8-1716a8e821ae2026-08-10WarningsExact identifier
application number: M020
ULTRA VIOLETTE Unblock Screen SPF 50 SunscreenBEMOTRIZINOL, OCTOCRYLENE, ZINC OXIDEGrace and Fire USA Inc.56ad0dce-410e-9d78-e063-6294a90a1c3e2026-08-09WarningsExact identifier
application number: M020
ORLASKIN SPF50 Antioxidant SoothingComplex SunscreenETHYLHEXYL METHOXYCINNAMATE ETHYLHEXYL SALICYLATE BUTYL METHOXYDIBENZOYLMETHANE ZINC OXIDE BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINEGuangzhou Yapheon Health Industry Co., Ltd.552a36ed-7a66-4048-e063-6394a90a09bc2026-08-08WarningsExact identifier
application number: M020
lip balm SPF15( 2533) 01AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.5870aa44-1375-cdc5-e063-6394a90af4a52026-08-07WarningsExact identifier
application number: M020
lip balm SPF15( Zinc oxide) 01ZINC OXIDECosmuses Cosmetics (Ningbo) Co., Ltd.5871ab1d-cf07-d737-e063-6394a90a58fe2026-08-07WarningsExact 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