Softlips

Manufacturer: The Mentholatum Company
Effective date: 2024-12-17
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: full-release
Hydrated at: 2026-06-01 00:44:08

Label at a glance#

ProductSoftlips Vanilla Watermelon

Active ingredientDIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE

Label structure10 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, flavor, cetyl alcohol, myristyl laurate, myristyl alcohol, BHT, menthol, tocopheryl acetate [vitamin E]

Questions?

OTC - QUESTIONS SECTION

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

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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
10742-8478-1	2023-02-07	C162847	48780-1	f386c64a-1431-0266-e053-dadaa90a7c1a	Drug Facts - Softlips Vanilla Watermelon Blister Pack
10742-8478-1	2023-01-30	C162847	48780-1	f386c64a-1431-0266-e053-dadaa90a7c1a	Drug Facts - Softlips Vanilla Watermelon Blister Pack

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
10742-8478-1	SoftlipsVanilla Watermelon	3 in 1 BLISTER PACK	STICK	3		3
10742-8478-1	SoftlipsVanilla Watermelon	2 g in 1 TUBE	STICK	2		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10742-8478	SOFTLIPS VANILLA WATERMELON (DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE) STICK [THE MENTHOLATUM COMPANY]	3	Current NDC, Legacy NDC, 2 package rows	20241219_1fbe85a2-4cd7-45bd-85a2-83bbf75c5f97.zip

Products#

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

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
10742-8478	10742-8478-1

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
LEVOMENTHOL	BZ1R15MTK7	IACT
.ALPHA.-TOCOPHEROL	H4N855PNZ1	IACT
DIMETHICONE	92RU3N3Y1O	ACTIB
OCTINOXATE	4Y5P7MUD51	ACTIB
OCTISALATE	4X49Y0596W	ACTIB
OXYBENZONE	95OOS7VE0Y	ACTIB

Source Document#

Source XML

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 Watermelon	DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE	The Mentholatum Company	1fbe85a2-4cd7-45bd-85a2-83bbf75c5f97	2024-12-17	Warnings	Exact identifier ndc (package): 10742-8478-1 ndc (product): 10742-8478 ndc11 (package): 10742847801 spl id: 2979b07a-c0f7-37df-e063-6394a90ae1ff spl set id: 1fbe85a2-4cd7-45bd-85a2-83bbf75c5f97

Reported adverse events (FAERS/openFDA)#

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