Softlips

Manufacturer: The Mentholatum Company
Effective date: 2024-12-17
Label type: HUMAN OTC DRUG LABEL
Version: 5
Source: full-release
Hydrated at: 2026-06-01 00:44:15

Label at a glance#

ProductSoftlips Marshmallow Ghost

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

Label contents#

Full prescribing information#

Active ingredient

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

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.

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 increased 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

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DailyMed Pharmacologic Classes#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
10742-8510-1	2023-02-07	C162847	48780-1	f386c649-a540-0266-e053-dadaa90a7c1a	Drug Facts - Softlips Marshmallow Ghost
10742-8510-1	2023-01-30	C162847	48780-1	f386c649-a540-0266-e053-dadaa90a7c1a	Drug Facts - Softlips Marshmallow Ghost

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
10742-8510-1	SoftlipsMarshmallow Ghost	2 g in 1 TUBE	STICK	2		5
10742-8510-1	SoftlipsMarshmallow Ghost	1 in 1 BLISTER PACK	STICK	1		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10742-8510	SOFTLIPS MARSHMALLOW GHOST (DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE) STICK [THE MENTHOLATUM COMPANY]	5	Current NDC, Legacy NDC, 2 package rows	20241219_8d55141d-5d6f-4eec-87dc-d3c808cf7a6a.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
DIMETHICONE	ACTIVE INGREDIENT	92RU3N3Y1O	1
OCTINOXATE	ACTIVE INGREDIENT	4Y5P7MUD51	1
OCTISALATE	ACTIVE INGREDIENT	4X49Y0596W	1
OXYBENZONE	ACTIVE INGREDIENT	95OOS7VE0Y	1
DIMETHICONE	ACTIVE MOIETY	92RU3N3Y1O	1
OCTINOXATE	ACTIVE MOIETY	4Y5P7MUD51	1
OCTISALATE	ACTIVE MOIETY	4X49Y0596W	1
OXYBENZONE	ACTIVE MOIETY	95OOS7VE0Y	1
.ALPHA.-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	1
BUTYLATED HYDROXYTOLUENE	INACTIVE INGREDIENT	1P9D0Z171K	1
CERESIN	INACTIVE INGREDIENT	Q1LS2UJO3A	1
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	1
ETHYLHEXYL PALMITATE	INACTIVE INGREDIENT	2865993309	1
MENTHOL	INACTIVE INGREDIENT	L7T10EIP3A	1
MYRISTYL ALCOHOL	INACTIVE INGREDIENT	V42034O9PU	1
MYRISTYL LACTATE	INACTIVE INGREDIENT	1D822OC34X	1
MYRISTYL LAURATE	INACTIVE INGREDIENT	58U0NZN2BT	1
MYRISTYL MYRISTATE	INACTIVE INGREDIENT	4042ZC00DY	1
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	1
SQUALANE	INACTIVE INGREDIENT	GW89575KF9	1

Products#

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

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

Softlips Marshmallow Ghost
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 ACETATE
DIMETHICONE
OCTINOXATE
OCTISALATE
OXYBENZONE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
10742-8510	10742-8510-1

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 ACETATE	9E8X80D2L0	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 · 90 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SWAB / TOPICAL	0.5 %w/w		Exact identifier — unii+route 24 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	CREAM, AUGMENTED / TOPICAL	26 %w/w		Exact identifier — unii+route 18 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	OINTMENT / TOPICAL	7 %w/w		Exact identifier — unii+route 16 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SHAMPOO / TOPICAL	0.1 %w/w		Exact identifier — unii+route 24 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	AEROSOL, FOAM / TOPICAL		82 mg	Exact identifier — unii+route 16 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	CREAM / TOPICAL		6 mg	Exact identifier — unii+route 24 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	LOTION / TOPICAL		1000 mg	Exact identifier — unii+route 24 equally ranked IID candidates
SQUALANE	SQUALANE	GW89575KF9	AEROSOL, FOAM / TOPICAL	2.23 %w/w		Exact identifier — unii+route 8 equally ranked IID candidates
SQUALANE	SQUALANE	GW89575KF9	AEROSOL, FOAM / TOPICAL	2.23 %w/w		Exact identifier — unii+route 8 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	SPONGE / TOPICAL	NA		Exact identifier — unii+route 18 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	CREAM, AUGMENTED / TOPICAL	0.2 %w/w		Exact identifier — unii+route 24 equally ranked IID candidates
MYRISTYL ALCOHOL	MYRISTYL ALCOHOL	V42034O9PU	SUSPENSION / TOPICAL	1.05 %w/w		Exact identifier — unii+route 6 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	LOTION / TOPICAL		1140 mg	Exact identifier — unii+route 16 equally ranked IID candidates
SQUALANE	SQUALANE	GW89575KF9	CREAM / TOPICAL	6 %w/w		Exact identifier — unii+route 8 equally ranked IID candidates
MYRISTYL LACTATE	MYRISTYL LACTATE	1D822OC34X	LOTION / TOPICAL		64 mg	Exact identifier — unii+route 2 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	OINTMENT / TOPICAL	7 %w/w		Exact identifier — unii+route 16 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	GEL, METERED / TOPICAL		4 mg	Exact identifier — unii+route 24 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	AEROSOL, FOAM / TOPICAL		82 mg	Exact identifier — unii+route 16 equally ranked IID candidates
CERESIN	CERESIN	Q1LS2UJO3A	OINTMENT / TOPICAL		1097 mg	Exact identifier — unii+route 2 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	OINTMENT / TOPICAL		7275 mg	Exact identifier — unii+route 18 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	CREAM, AUGMENTED / TOPICAL	26 %w/w		Exact identifier — unii+route 18 equally ranked IID candidates
MYRISTYL ALCOHOL	MYRISTYL ALCOHOL	V42034O9PU	SUSPENSION / TOPICAL	1.05 %w/w		Exact identifier — unii+route 6 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	CREAM / TOPICAL		6 mg	Exact identifier — unii+route 24 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SWAB / TOPICAL	0.5 %w/w		Exact identifier — unii+route 24 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	OINTMENT, AUGMENTED / TOPICAL	81.94 %w/w		Exact identifier — unii+route 18 equally ranked IID candidates
MYRISTYL ALCOHOL	MYRISTYL ALCOHOL	V42034O9PU	AEROSOL, FOAM / TOPICAL	2.5 %w/w		Exact identifier — unii+route 6 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SOLUTION / TOPICAL		3 mg	Exact identifier — unii+route 24 equally ranked IID candidates
MYRISTYL LACTATE	MYRISTYL LACTATE	1D822OC34X	LOTION / TOPICAL		64 mg	Exact identifier — unii+route 2 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	SOAP / TOPICAL	0.85 %w/w		Exact identifier — unii+route 18 equally ranked IID candidates
MYRISTYL ALCOHOL	MYRISTYL ALCOHOL	V42034O9PU	CREAM / TOPICAL	3 %w/w		Exact identifier — unii+route 6 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	CREAM / TOPICAL		1280 mg	Exact identifier — unii+route 16 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SOAP / TOPICAL	0.02 %w/w		Exact identifier — unii+route 24 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	LOTION / TOPICAL		1140 mg	Exact identifier — unii+route 16 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	AEROSOL / TOPICAL	1.16 %w/w		Exact identifier — unii+route 16 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	FILM / BUCCAL	0.09 mg		Exact identifier — unii candidate 6 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	CREAM / TOPICAL	0.1 %w/w		Exact identifier — unii+route 8 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	FILM / BUCCAL	0.09 mg		Exact identifier — unii candidate 6 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	EMULSION / TOPICAL	NA		Exact identifier — unii+route 16 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	OINTMENT / TOPICAL		57 mg	Exact identifier — unii+route 24 equally ranked IID candidates
SQUALANE	SQUALANE	GW89575KF9	CREAM, AUGMENTED / TOPICAL		120 mg	Exact identifier — unii+route 8 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	AEROSOL, FOAM / TOPICAL	7.9 %w/w		Exact identifier — unii+route 18 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	CAPSULE / ORAL	2 mg		Exact identifier — unii candidate 6 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	SOAP / TOPICAL	0.75 %w/w		Exact identifier — unii+route 8 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	LOTION / TOPICAL	25 %w/w		Exact identifier — unii+route 18 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	CREAM / TOPICAL		4213 mg	Exact identifier — unii+route 18 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	LOTION / TOPICAL	0.05 %w/w		Exact identifier — unii+route 8 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	LOTION / TOPICAL	25 %w/w		Exact identifier — unii+route 18 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	SOAP / TOPICAL	0.75 %w/w		Exact identifier — unii+route 8 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	OINTMENT / TOPICAL		7275 mg	Exact identifier — unii+route 18 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	SOLUTION / TOPICAL	NA		Exact identifier — unii+route 16 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	OINTMENT, AUGMENTED / TOPICAL	81.94 %w/w		Exact identifier — unii+route 18 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	AEROSOL / TOPICAL	1.16 %w/w		Exact identifier — unii+route 16 equally ranked IID candidates
MYRISTYL ALCOHOL	MYRISTYL ALCOHOL	V42034O9PU	AEROSOL, FOAM / TOPICAL	2.5 %w/w		Exact identifier — unii+route 6 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	OINTMENT / TOPICAL		57 mg	Exact identifier — unii+route 24 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	LOTION / TOPICAL	0.05 %w/w		Exact identifier — unii+route 8 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	SUSPENSION / TOPICAL	2.01 %w/w		Exact identifier — unii+route 16 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	GEL / TOPICAL		8 mg	Exact identifier — unii+route 24 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	AEROSOL, FOAM / TOPICAL		4 mg	Exact identifier — unii+route 24 equally ranked IID candidates
SQUALANE	SQUALANE	GW89575KF9	CREAM / TOPICAL	6 %w/w		Exact identifier — unii+route 8 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	AEROSOL, FOAM / TOPICAL		4 mg	Exact identifier — unii+route 24 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 Marshmallow Ghost	DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE	The Mentholatum Company	8d55141d-5d6f-4eec-87dc-d3c808cf7a6a	2024-12-17	Warnings	Exact identifier ndc (package): 10742-8510-1 ndc (product): 10742-8510 ndc11 (package): 10742851001 spl id: 2979ca06-f086-f135-e063-6294a90ad1fa spl set id: 8d55141d-5d6f-4eec-87dc-d3c808cf7a6a

Reported adverse events (FAERS/openFDA)#

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