Softlips

Manufacturer: The Mentholatum Company
Effective date: 2025-11-19
Label type: HUMAN OTC DRUG LABEL
Version: 8
Source: full-release
Hydrated at: 2026-06-01 01:17:17

Label at a glance#

ProductSoftlips Vanilla

Active ingredientDIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE

Label structure9 sections

Indications and uses

helps prevent sunburn temporarily protects chapped or cracked lips

Dosage and administration

apply liberally 15 minutes before sun exposure use a water resistant sunscreen if swimming or sweating reapply at least every 2 hours children under 6 months: ask a doctor

Storage and handling

protect this product from excessive heat and direct sun

Contacts and useful links#

PhoneLabel contact1-877-636-2677

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Dimethicone 2%

Octinoxate 7.5%

Octisalate 3%

Oxybenzone 3%

Purpose

OTC - PURPOSE SECTION

Dimethicone - Skin protectant

Octinoxate - Sunscreen

Octisalate - Sunscreen

Oxybenzone - Sunscreen

Uses

INDICATIONS & USAGE SECTION

helps prevent sunburn
temporarily protects chapped or cracked lips

Warnings

WARNINGS SECTION

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

For external use only

Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin

When using this product

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

OTC - STOP USE SECTION

rash occurs
condition worsens
symptoms last more than 7 days or clear up and occur again within a few days

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

apply liberally 15 minutes before sun exposure
use a water resistant sunscreen if swimming or sweating
reapply at least every 2 hours
children under 6 months: ask a doctor

Other information

STORAGE AND HANDLING SECTION

protect this product from excessive heat and direct sun

Inactive ingredients

INACTIVE INGREDIENT SECTION

ozokerite, squalane, ethylhexyl palmitate, petrolatum, myristyl myristate, myristyl lactate, cetyl alcohol, myristyl laurate, myristyl alcohol, BHT, flavor, menthol, tocopheryl acetatate [vitamin E]

Questions?

OTC - QUESTIONS SECTION

Toll free 1-877-636-2677 MON-FRI 9AM to 5PM (EST) softlips.com

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image 1

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
DIMETHICONE Pharmacologic Class Indexing	3	Indexing - Pharmacologic Class	20180813

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	EAN-13	0310742012187	GTIN-13: 0310742012187 EAN-13: 0310742012187 GTIN-12: 310742012187 UPC-A: 310742012187 GTIN storage (14 digits): 00310742012187	Softlips Vanilla SPF 20.jpg
Data code	Code 128	340007		Softlips Vanilla SPF 20.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
10742-3051-1	2023-02-07	C162847	48780-1	f386c649-ba4c-0266-e053-dadaa90a7c1a	Drug Facts - Softlips Vanilla SPF 20
10742-3051-2	2023-02-07	C162847	48780-1	f386c649-ba4c-0266-e053-dadaa90a7c1a	Drug Facts - Softlips Vanilla SPF 20
10742-3051-3	2023-02-07	C162847	48780-1	f386c649-ba4c-0266-e053-dadaa90a7c1a	Drug Facts - Softlips Vanilla SPF 20
10742-3051-9	2023-02-07	C162847	48780-1	f386c649-ba4c-0266-e053-dadaa90a7c1a	Drug Facts - Softlips Vanilla SPF 20
10742-3051-1	2023-01-30	C162847	48780-1	f386c649-ba4c-0266-e053-dadaa90a7c1a	Drug Facts - Softlips Vanilla SPF 20
10742-3051-2	2023-01-30	C162847	48780-1	f386c649-ba4c-0266-e053-dadaa90a7c1a	Drug Facts - Softlips Vanilla SPF 20
10742-3051-3	2023-01-30	C162847	48780-1	f386c649-ba4c-0266-e053-dadaa90a7c1a	Drug Facts - Softlips Vanilla SPF 20
10742-3051-9	2023-01-30	C162847	48780-1	f386c649-ba4c-0266-e053-dadaa90a7c1a	Drug Facts - Softlips Vanilla SPF 20

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
10742-3051-1	SoftlipsVanilla	2 g in 1 TUBE	OINTMENT	2	8
10742-3051-1	SoftlipsVanilla	1 in 1 BLISTER PACK	OINTMENT	1	8
10742-3051-2	SoftlipsVanilla	2 g in 1 TUBE	OINTMENT	2	8
10742-3051-3	SoftlipsVanilla	3 in 1 BLISTER PACK	OINTMENT	3	8
10742-3051-3	SoftlipsVanilla	2 g in 1 TUBE	OINTMENT	2	8
10742-3051-9	SoftlipsVanilla	2 g in 1 TUBE	OINTMENT	2	8
10742-3051-9	SoftlipsVanilla	2 in 1 BLISTER PACK	OINTMENT	2	8

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
DIMETHICONE	ACTIVE INGREDIENT	92RU3N3Y1O	3
OCTINOXATE	ACTIVE INGREDIENT	4Y5P7MUD51	3
OCTISALATE	ACTIVE INGREDIENT	4X49Y0596W	3
OXYBENZONE	ACTIVE INGREDIENT	95OOS7VE0Y	3
DIMETHICONE	ACTIVE MOIETY	92RU3N3Y1O	3
OCTINOXATE	ACTIVE MOIETY	4Y5P7MUD51	3
OCTISALATE	ACTIVE MOIETY	4X49Y0596W	3
OXYBENZONE	ACTIVE MOIETY	95OOS7VE0Y	3
.ALPHA.-TOCOPHEROL	INACTIVE INGREDIENT	H4N855PNZ1	3
BUTYLATED HYDROXYTOLUENE	INACTIVE INGREDIENT	1P9D0Z171K	3
CERESIN	INACTIVE INGREDIENT	Q1LS2UJO3A	3
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	3
ETHYLHEXYL PALMITATE	INACTIVE INGREDIENT	2865993309	3
MENTHOL	INACTIVE INGREDIENT	L7T10EIP3A	3
MYRISTYL ALCOHOL	INACTIVE INGREDIENT	V42034O9PU	3
MYRISTYL LACTATE	INACTIVE INGREDIENT	1D822OC34X	3
MYRISTYL LAURATE	INACTIVE INGREDIENT	58U0NZN2BT	3
MYRISTYL MYRISTATE	INACTIVE INGREDIENT	4042ZC00DY	3
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	3
SQUALANE	INACTIVE INGREDIENT	GW89575KF9	3

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 18 matching rows.

Softlips Vanilla
dimethicone, octinoxate, octisalate, oxybenzone
CERESIN
SQUALANE
ETHYLHEXYL PALMITATE
PETROLATUM
MYRISTYL MYRISTATE
MYRISTYL LACTATE
CETYL ALCOHOL
MYRISTYL LAURATE
MYRISTYL ALCOHOL
BUTYLATED HYDROXYTOLUENE
MENTHOL, UNSPECIFIED FORM
.ALPHA.-TOCOPHEROL
DIMETHICONE
OCTINOXATE
OCTISALATE
OXYBENZONE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
10742-3051	10742-3051-1, 10742-3051-9, 10742-3051-2, 10742-3051-3

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CERESIN	Q1LS2UJO3A	IACT
SQUALANE	GW89575KF9	IACT
ETHYLHEXYL PALMITATE	2865993309	IACT
PETROLATUM	4T6H12BN9U	IACT
MYRISTYL MYRISTATE	4042ZC00DY	IACT
MYRISTYL LACTATE	1D822OC34X	IACT
CETYL ALCOHOL	936JST6JCN	IACT
MYRISTYL LAURATE	58U0NZN2BT	IACT
MYRISTYL ALCOHOL	V42034O9PU	IACT
BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	IACT
MENTHOL, UNSPECIFIED FORM	L7T10EIP3A	IACT
.ALPHA.-TOCOPHEROL	H4N855PNZ1	IACT
DIMETHICONE	92RU3N3Y1O	ACTIB
OCTINOXATE	4Y5P7MUD51	ACTIB
OCTISALATE	4X49Y0596W	ACTIB
OXYBENZONE	95OOS7VE0Y	ACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 2 · 85 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
MENTHOL	MENTHOL	L7T10EIP3A	SOAP / TOPICAL	0.75 %w/w		Exact identifier — unii+route 20 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	SOAP / TOPICAL	0.75 %w/w		Exact identifier — unii+route 20 equally ranked IID candidates
MYRISTYL LACTATE	MYRISTYL LACTATE	1D822OC34X	LOTION / TOPICAL		64 mg	Exact identifier — unii+route 5 equally ranked IID candidates
SQUALANE	SQUALANE	GW89575KF9	AEROSOL, FOAM / TOPICAL	2.23 %w/w		Exact identifier — unii+route 20 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	GEL / TOPICAL	0.1 %w/w		Exact identifier — unii+route 20 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	GEL / TOPICAL	0.1 %w/w		Exact identifier — unii+route 20 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	OINTMENT / TOPICAL		57 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	OINTMENT / TOPICAL		7275 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	OINTMENT / TOPICAL	7 %w/w		Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	GEL / TOPICAL	0.1 %w/w		Exact identifier — unii+route 20 equally ranked IID candidates
CERESIN	CERESIN	Q1LS2UJO3A	OINTMENT / TOPICAL		1097 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
SQUALANE	SQUALANE	GW89575KF9	CREAM, AUGMENTED / TOPICAL		120 mg	Exact identifier — unii+route 20 equally ranked IID candidates
.ALPHA.-TOCOPHEROL	.ALPHA.-TOCOPHEROL	H4N855PNZ1	OINTMENT / TOPICAL	NA		Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
MYRISTYL ALCOHOL	MYRISTYL ALCOHOL	V42034O9PU	SUSPENSION / TOPICAL	1.05 %w/w		Exact identifier — unii+route 15 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	LOTION / TOPICAL	0.05 %w/w		Exact identifier — unii+route 20 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	SOAP / TOPICAL	0.75 %w/w		Exact identifier — unii+route 20 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	OINTMENT / TOPICAL	7 %w/w		Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
MYRISTYL ALCOHOL	MYRISTYL ALCOHOL	V42034O9PU	SUSPENSION / TOPICAL	1.05 %w/w		Exact identifier — unii+route 15 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	OINTMENT / TOPICAL		57 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	CREAM / TOPICAL	0.1 %w/w		Exact identifier — unii+route 20 equally ranked IID candidates
SQUALANE	SQUALANE	GW89575KF9	CREAM, AUGMENTED / TOPICAL		120 mg	Exact identifier — unii+route 20 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	GEL / TOPICAL	0.1 %w/w		Exact identifier — unii+route 20 equally ranked IID candidates
.ALPHA.-TOCOPHEROL	.ALPHA.-TOCOPHEROL	H4N855PNZ1	OINTMENT / TOPICAL	NA		Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
MYRISTYL ALCOHOL	MYRISTYL ALCOHOL	V42034O9PU	AEROSOL, FOAM / TOPICAL	2.5 %w/w		Exact identifier — unii+route 15 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	OINTMENT / TOPICAL		57 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
MYRISTYL ALCOHOL	MYRISTYL ALCOHOL	V42034O9PU	SUSPENSION / TOPICAL	1.05 %w/w		Exact identifier — unii+route 15 equally ranked IID candidates
SQUALANE	SQUALANE	GW89575KF9	AEROSOL, FOAM / TOPICAL	2.23 %w/w		Exact identifier — unii+route 20 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	CREAM / TOPICAL	0.1 %w/w		Exact identifier — unii+route 20 equally ranked IID candidates
SQUALANE	SQUALANE	GW89575KF9	CREAM, AUGMENTED / TOPICAL		120 mg	Exact identifier — unii+route 20 equally ranked IID candidates
.ALPHA.-TOCOPHEROL	.ALPHA.-TOCOPHEROL	H4N855PNZ1	OINTMENT / TOPICAL	NA		Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
.ALPHA.-TOCOPHEROL	.ALPHA.-TOCOPHEROL	H4N855PNZ1	OINTMENT / TOPICAL	NA		Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
.ALPHA.-TOCOPHEROL	.ALPHA.-TOCOPHEROL	H4N855PNZ1	OINTMENT / TOPICAL	NA		Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	LOTION / TOPICAL	0.05 %w/w		Exact identifier — unii+route 20 equally ranked IID candidates
MYRISTYL ALCOHOL	MYRISTYL ALCOHOL	V42034O9PU	CREAM / TOPICAL	3 %w/w		Exact identifier — unii+route 15 equally ranked IID candidates
MYRISTYL LACTATE	MYRISTYL LACTATE	1D822OC34X	LOTION / TOPICAL		64 mg	Exact identifier — unii+route 5 equally ranked IID candidates
CERESIN	CERESIN	Q1LS2UJO3A	OINTMENT / TOPICAL		1097 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
MYRISTYL ALCOHOL	MYRISTYL ALCOHOL	V42034O9PU	AEROSOL, FOAM / TOPICAL	2.5 %w/w		Exact identifier — unii+route 15 equally ranked IID candidates
MYRISTYL LACTATE	MYRISTYL LACTATE	1D822OC34X	LOTION / TOPICAL		64 mg	Exact identifier — unii+route 5 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	OINTMENT / TOPICAL	7 %w/w		Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
MYRISTYL ALCOHOL	MYRISTYL ALCOHOL	V42034O9PU	SUSPENSION / TOPICAL	1.05 %w/w		Exact identifier — unii+route 15 equally ranked IID candidates
MYRISTYL ALCOHOL	MYRISTYL ALCOHOL	V42034O9PU	AEROSOL, FOAM / TOPICAL	2.5 %w/w		Exact identifier — unii+route 15 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	OINTMENT / TOPICAL	7 %w/w		Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	OINTMENT / TOPICAL		7275 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
SQUALANE	SQUALANE	GW89575KF9	AEROSOL, FOAM / TOPICAL	2.23 %w/w		Exact identifier — unii+route 20 equally ranked IID candidates
SQUALANE	SQUALANE	GW89575KF9	CREAM, AUGMENTED / TOPICAL		120 mg	Exact identifier — unii+route 20 equally ranked IID candidates
SQUALANE	SQUALANE	GW89575KF9	AEROSOL, FOAM / TOPICAL	2.23 %w/w		Exact identifier — unii+route 20 equally ranked IID candidates
SQUALANE	SQUALANE	GW89575KF9	AEROSOL, FOAM / TOPICAL	2.23 %w/w		Exact identifier — unii+route 20 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	LOTION / TOPICAL	0.05 %w/w		Exact identifier — unii+route 20 equally ranked IID candidates
SQUALANE	SQUALANE	GW89575KF9	SOLUTION / TOPICAL	1 %w/w		Exact identifier — unii+route 20 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	LOTION / TOPICAL	0.05 %w/w		Exact identifier — unii+route 20 equally ranked IID candidates
SQUALANE	SQUALANE	GW89575KF9	CREAM / TOPICAL	6 %w/w		Exact identifier — unii+route 20 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	SOAP / TOPICAL	0.75 %w/w		Exact identifier — unii+route 20 equally ranked IID candidates
SQUALANE	SQUALANE	GW89575KF9	CREAM / TOPICAL	6 %w/w		Exact identifier — unii+route 20 equally ranked IID candidates
MYRISTYL ALCOHOL	MYRISTYL ALCOHOL	V42034O9PU	CREAM / TOPICAL	3 %w/w		Exact identifier — unii+route 15 equally ranked IID candidates
MYRISTYL ALCOHOL	MYRISTYL ALCOHOL	V42034O9PU	AEROSOL, FOAM / TOPICAL	2.5 %w/w		Exact identifier — unii+route 15 equally ranked IID candidates
MYRISTYL ALCOHOL	MYRISTYL ALCOHOL	V42034O9PU	CREAM / TOPICAL	3 %w/w		Exact identifier — unii+route 15 equally ranked IID candidates
MYRISTYL ALCOHOL	MYRISTYL ALCOHOL	V42034O9PU	CREAM / TOPICAL	3 %w/w		Exact identifier — unii+route 15 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	CREAM / TOPICAL	0.1 %w/w		Exact identifier — unii+route 20 equally ranked IID candidates
SQUALANE	SQUALANE	GW89575KF9	CREAM, AUGMENTED / TOPICAL		120 mg	Exact identifier — unii+route 20 equally ranked IID candidates
MYRISTYL LACTATE	MYRISTYL LACTATE	1D822OC34X	LOTION / TOPICAL		64 mg	Exact identifier — unii+route 5 equally ranked IID candidates

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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Softlips Vanilla	DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE	The Mentholatum Company	8dff782f-7201-4ad9-94d2-672058f817b8	2025-11-19	Warnings	Exact identifier ndc (package): 10742-3051-2 ndc (package): 10742-3051-9 ndc (package): 10742-3051-1 ndc (package): 10742-3051-3 ndc (product): 10742-3051 ndc11 (package): 10742305101 ndc11 (package): 10742305109 ndc11 (package): 10742305103 ndc11 (package): 10742305102 spl id: 43fde22f-2a7f-7b72-e063-6294a90a3254 spl set id: 8dff782f-7201-4ad9-94d2-672058f817b8

Reported adverse events (FAERS/openFDA)#

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