Petroleum-Free Lip Balm

Manufacturer: Medline Industries, LP
Effective date: 2025-10-09
Label type: HUMAN OTC DRUG LABEL
Version: 8
Source: full-release
Hydrated at: 2026-06-01 01:38:31

Label at a glance#

ProductPetroleum-Free Lip Balm

Active ingredientOCTINOXATE, OXYBENZONE

Label structure10 sections

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

Contacts and useful links#

PhoneLabel contact1-800-633-5463

Websitewww.curad.com

www.curad.com

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 2.0%

Oxybenzone 4.5%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Use

INDICATIONS & USAGE SECTION

helps protect against sunburn and chapped 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 help 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 or irritation develops and lasts

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help of 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

SPL UNCLASSIFIED SECTION

protect this product from excessive heat and direct sun
to report a suspected adverse reaction, contact Curad.

Inactive ingredients

INACTIVE INGREDIENT SECTION

beeswax, BHT, cocos nucifera (coconut) oil, flavor, helianthus annuus (sunflower) seed oil, lanolin, melaleuca alternifolia (tea tree) leaf oil, ricinus communis (castor) seed oil, tocopheryl acetate, zea mays (corn) oil.

Manufacturing Information

SPL UNCLASSIFIED SECTION

Manufactured for:

Medline Industries, LP

Three Lakes Drive, Northfield, IL 60093 USA

Made in USA of foreign and domestic materials

www.curad.com

1-800-633-5463

REF: CUR0415

V1 RD22OLB

RECENT MAJOR CHANGES SECTION

Indications and Usage

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label V1 RD22OLB

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53329-092-83	2023-08-08	C162847	48780-1	e4f33bdf-a787-d8a0-e053-dadaa90a6e4e	092 Curad Petroleum-Free Lip Balm
53329-092-83	2023-08-08	C162847	48780-1	e4f33bdf-a787-d8a0-e053-dadaa90a6e4e	092 Curad Petroleum-Free Lip Balm
53329-092-83	2023-07-28	C162847	48780-1	e4f33bdf-a787-d8a0-e053-dadaa90a6e4e	092 Curad Petroleum-Free Lip Balm
53329-092-83	2023-07-28	C162847	48780-1	e4f33bdf-a787-d8a0-e053-dadaa90a6e4e	092 Curad Petroleum-Free Lip Balm
53329-092-83	2022-09-27	C162847	48780-1	e4f33bdf-a787-d8a0-e053-dadaa90a6e4e	092 Curad Petroleum-Free Lip Balm
53329-092-83	2022-09-27	C162847	48780-1	e4f33bdf-a787-d8a0-e053-dadaa90a6e4e	092 Curad Petroleum-Free Lip Balm
53329-092-83	2022-07-29	C162847	48780-1	e4f33bdf-a787-d8a0-e053-dadaa90a6e4e	092 Curad Petroleum-Free Lip Balm
53329-092-83	2022-07-29	C162847	48780-1	e4f33bdf-a787-d8a0-e053-dadaa90a6e4e	092 Curad Petroleum-Free Lip Balm

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53329-092-83	Petroleum-Free Lip Balm	4.2 g in 1 CONTAINER	LIPSTICK	4.2		8
53329-092-83	Petroleum-Free Lip Balm	1 in 1 BOX	LIPSTICK	1		8

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
OCTINOXATE	ACTIVE INGREDIENT	4Y5P7MUD51	1
OXYBENZONE	ACTIVE INGREDIENT	95OOS7VE0Y	1
OCTINOXATE	ACTIVE MOIETY	4Y5P7MUD51	1
OXYBENZONE	ACTIVE MOIETY	95OOS7VE0Y	1
ALPHA-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	1
BUTYLATED HYDROXYTOLUENE	INACTIVE INGREDIENT	1P9D0Z171K	1
CASTOR OIL	INACTIVE INGREDIENT	D5340Y2I9G	1
COCONUT OIL	INACTIVE INGREDIENT	Q9L0O73W7L	1
CORN OIL	INACTIVE INGREDIENT	8470G57WFM	1
LANOLIN	INACTIVE INGREDIENT	7EV65EAW6H	1
SUNFLOWER OIL	INACTIVE INGREDIENT	3W1JG795YI	1
TEA TREE OIL	INACTIVE INGREDIENT	VIF565UC2G	1
YELLOW WAX	INACTIVE INGREDIENT	2ZA36H0S2V	1

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

Petroleum-Free Lip Balm
Octinoxate and Oxybenzone
YELLOW WAX
SUNFLOWER OIL
CASTOR OIL
LANOLIN
COCONUT OIL
CORN OIL
BUTYLATED HYDROXYTOLUENE
ALPHA-TOCOPHEROL ACETATE
TEA TREE OIL
OCTINOXATE
OXYBENZONE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
53329-092	53329-092-83

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
YELLOW WAX	2ZA36H0S2V	IACT
SUNFLOWER OIL	3W1JG795YI	IACT
CASTOR OIL	D5340Y2I9G	IACT
LANOLIN	7EV65EAW6H	IACT
COCONUT OIL	Q9L0O73W7L	IACT
CORN OIL	8470G57WFM	IACT
BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	IACT
ALPHA-TOCOPHEROL ACETATE	9E8X80D2L0	IACT
TEA TREE OIL	VIF565UC2G	IACT
OCTINOXATE	4Y5P7MUD51	ACTIB
OXYBENZONE	95OOS7VE0Y	ACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
Version	Effective date	Source	Hydrated
7	2024-12-02	full-release	2026-06-01 00:40:08

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 1 · 58 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
ALPHA-TOCOPHEROL ACETATE	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	CAPSULE / ORAL	2 mg		Exact identifier — unii candidate 6 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	GEL, METERED / TOPICAL		4 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
COCONUT OIL	COCONUT OIL	Q9L0O73W7L	SOLUTION / TOPICAL	15.5 %w/w		Exact identifier — unii+route 8 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	LOTION / TOPICAL		1000 mg	Exact identifier — unii+route 24 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
LANOLIN	LANOLIN	7EV65EAW6H	CREAM / TOPICAL		10 mg	Exact identifier — unii+route 10 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	AEROSOL, FOAM / TOPICAL		4 mg	Exact identifier — unii+route 24 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SHAMPOO / TOPICAL	0.1 %w/w		Exact identifier — unii+route 24 equally ranked IID candidates
CASTOR OIL	CASTOR OIL	D5340Y2I9G	SOLUTION / TOPICAL	1.38 %w/w		Exact identifier — unii+route 4 equally ranked IID candidates
LANOLIN	LANOLIN	7EV65EAW6H	LOTION / TOPICAL	1.5 %w/w		Exact identifier — unii+route 10 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	CREAM / TOPICAL		6 mg	Exact identifier — unii+route 24 equally ranked IID candidates
COCONUT OIL	COCONUT OIL	Q9L0O73W7L	SOAP / TOPICAL	4.6 %w/w		Exact identifier — unii+route 8 equally ranked IID candidates
COCONUT OIL	COCONUT OIL	Q9L0O73W7L	AEROSOL, FOAM / TOPICAL	23.6 %w/w		Exact identifier — unii+route 8 equally ranked IID candidates
YELLOW WAX	YELLOW WAX	2ZA36H0S2V	OINTMENT / TOPICAL	20 %w/w		Exact identifier — unii+route 4 equally ranked IID candidates
LANOLIN	LANOLIN	7EV65EAW6H	LOTION / TOPICAL	1.5 %w/w		Exact identifier — unii+route 10 equally ranked IID candidates
LANOLIN	LANOLIN	7EV65EAW6H	SHAMPOO / TOPICAL	2 %w/w		Exact identifier — unii+route 10 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SPRAY / TOPICAL		3 mg	Exact identifier — unii+route 24 equally ranked IID candidates
LANOLIN	LANOLIN	7EV65EAW6H	EMULSION / TOPICAL	0.25 %w/w		Exact identifier — unii+route 10 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
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	OINTMENT / TOPICAL		57 mg	Exact identifier — unii+route 24 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SOLUTION / TOPICAL		3 mg	Exact identifier — unii+route 24 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SOLUTION / TOPICAL		3 mg	Exact identifier — unii+route 24 equally ranked IID candidates
LANOLIN	LANOLIN	7EV65EAW6H	EMULSION / TOPICAL	0.25 %w/w		Exact identifier — unii+route 10 equally ranked IID candidates
YELLOW WAX	YELLOW WAX	2ZA36H0S2V	CREAM / TOPICAL	5 %w/w		Exact identifier — unii+route 4 equally ranked IID candidates
CORN OIL	CORN OIL	8470G57WFM	CREAM / TOPICAL	NA		Exact identifier — unii+route 2 equally ranked IID candidates
ALPHA-TOCOPHEROL ACETATE	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	TABLET / ORAL	0.5 mg		Exact identifier — unii candidate 6 equally ranked IID candidates
LANOLIN	LANOLIN	7EV65EAW6H	CREAM / TOPICAL		10 mg	Exact identifier — unii+route 10 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	AEROSOL, FOAM / TOPICAL		4 mg	Exact identifier — unii+route 24 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
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	LOTION / TOPICAL		1000 mg	Exact identifier — unii+route 24 equally ranked IID candidates
COCONUT OIL	COCONUT OIL	Q9L0O73W7L	SOAP / TOPICAL	4.6 %w/w		Exact identifier — unii+route 8 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	GEL, METERED / TOPICAL		4 mg	Exact identifier — unii+route 24 equally ranked IID candidates
LANOLIN	LANOLIN	7EV65EAW6H	OINTMENT / TOPICAL	10 %w/w		Exact identifier — unii+route 10 equally ranked IID candidates
COCONUT OIL	COCONUT OIL	Q9L0O73W7L	OINTMENT / TOPICAL	14.75 %w/w		Exact identifier — unii+route 8 equally ranked IID candidates
COCONUT OIL	COCONUT OIL	Q9L0O73W7L	SOLUTION / TOPICAL	15.5 %w/w		Exact identifier — unii+route 8 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SHAMPOO / TOPICAL	0.1 %w/w		Exact identifier — unii+route 24 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SPRAY / TOPICAL		3 mg	Exact identifier — unii+route 24 equally ranked IID candidates
COCONUT OIL	COCONUT OIL	Q9L0O73W7L	AEROSOL, FOAM / TOPICAL	23.6 %w/w		Exact identifier — unii+route 8 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	OINTMENT / TOPICAL		57 mg	Exact identifier — unii+route 24 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	GEL / TOPICAL		8 mg	Exact identifier — unii+route 24 equally ranked IID candidates
ALPHA-TOCOPHEROL ACETATE	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	CAPSULE / ORAL	2 mg		Exact identifier — unii candidate 6 equally ranked IID candidates
ALPHA-TOCOPHEROL ACETATE	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	TABLET / ORAL	0.5 mg		Exact identifier — unii candidate 6 equally ranked IID candidates
LANOLIN	LANOLIN	7EV65EAW6H	SHAMPOO / TOPICAL	2 %w/w		Exact identifier — unii+route 10 equally ranked IID candidates
CORN OIL	CORN OIL	8470G57WFM	CREAM / TOPICAL	NA		Exact identifier — unii+route 2 equally ranked IID candidates
YELLOW WAX	YELLOW WAX	2ZA36H0S2V	OINTMENT / TOPICAL	20 %w/w		Exact identifier — unii+route 4 equally ranked IID candidates
CASTOR OIL	CASTOR OIL	D5340Y2I9G	OINTMENT / TOPICAL	14.9 %w/w		Exact identifier — unii+route 4 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	CREAM / TOPICAL		6 mg	Exact identifier — unii+route 24 equally ranked IID candidates
YELLOW WAX	YELLOW WAX	2ZA36H0S2V	CREAM / TOPICAL	5 %w/w		Exact identifier — unii+route 4 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SOAP / TOPICAL	0.02 %w/w		Exact identifier — unii+route 24 equally ranked IID candidates
LANOLIN	LANOLIN	7EV65EAW6H	OINTMENT / TOPICAL	10 %w/w		Exact identifier — unii+route 10 equally ranked IID candidates
COCONUT OIL	COCONUT OIL	Q9L0O73W7L	OINTMENT / TOPICAL	14.75 %w/w		Exact identifier — unii+route 8 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SOAP / TOPICAL	0.02 %w/w		Exact identifier — unii+route 24 equally ranked IID candidates
CASTOR OIL	CASTOR OIL	D5340Y2I9G	OINTMENT / TOPICAL	14.9 %w/w		Exact identifier — unii+route 4 equally ranked IID candidates
CASTOR OIL	CASTOR OIL	D5340Y2I9G	SOLUTION / TOPICAL	1.38 %w/w		Exact identifier — unii+route 4 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

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
Petroleum-Free Lip Balm	OCTINOXATE AND OXYBENZONE	Medline Industries, LP	6125d98a-6fc7-4f50-924e-3b1f7ee951f4	2025-10-09	Warnings	Exact identifier ndc (package): 53329-092-83 ndc (product): 53329-092 ndc11 (package): 53329009283 spl id: 40c101e4-f9c5-4766-e063-6294a90aaa46 spl set id: 6125d98a-6fc7-4f50-924e-3b1f7ee951f4

Reported adverse events (FAERS/openFDA)#

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