Lip Balm

Manufacturer: Tri-Coastal Design Company Inc. | Guangzhou St Eva Fine Chemical Co Ltd
Effective date: 2010-02-12
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:23:43

Label at a glance#

ProductLip Balm

Active ingredientOCTINOXATE, OXYBENZONE, DIMETHICONE

Label structure7 sections

Indications and uses

Helps prevent sunburn Temporarily protects and relieves chapped lips

Dosage and administration

Apply liberally before sun exposure and as needed.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Octyl Methoxycinnamate 6%

Oxybenzone 6%

Dimethicone 1%

Purpose

OTC - PURPOSE SECTION

Sunscreen
Skin Protectant

Uses

INDICATIONS & USAGE SECTION

Helps prevent sunburn
Temporarily protects and relieves chapped lips

Warnings

WARNINGS SECTION

Keep out of eyes. Stop use if rash or irritation occurs. Keep out of reach of children. For external use only.

Directions

DOSAGE & ADMINISTRATION SECTION

Apply liberally before sun exposure and as needed.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

BHA, BHT, Caprylic/Capric Triglyceride, Cera Microcristallina, Flavor, Lanolin, Mineral Oil (Paraffinum Liquidum), Ozokerite, Petrolatum, Phenyl Trimethicone, Polyethylene, Propylparaben, PVP/Eicosene Copolymer, Tocopheryl Acetate

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package Label

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
49852-202-05	2020-01-31	C162847	48780-1	9d75b9cf-cda6-f424-e053-dadaa90a57ce	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
49852-202-05	Lip Balm	5 in 1 BOX	LIPSTICK	5		1
49852-202-35	Lip Balm	3.5 g in 1 TUBE	LIPSTICK	3.5		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49852-202	LIP BALM (OCTINOXATE OXYBENZONE DIMETHICONE) LIPSTICK [TRI-COASTAL DESIGN COMPANY INC. ]	1	Legacy NDC, 2 package rows	20100228_1261d499-c2e1-473b-8407-bd0d0cf1c52a.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
DIMETHICONE	ACTIVE INGREDIENT	92RU3N3Y1O	1
OCTINOXATE	ACTIVE INGREDIENT	4Y5P7MUD51	1
OXYBENZONE	ACTIVE INGREDIENT	95OOS7VE0Y	1
DIMETHICONE	ACTIVE MOIETY	92RU3N3Y1O	1
OCTINOXATE	ACTIVE MOIETY	4Y5P7MUD51	1
OXYBENZONE	ACTIVE MOIETY	95OOS7VE0Y	1
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	1
BUTYLATED HYDROXYTOLUENE	INACTIVE INGREDIENT	1P9D0Z171K	1
LANOLIN	INACTIVE INGREDIENT	7EV65EAW6H	1
MEDIUM-CHAIN TRIGLYCERIDES	INACTIVE INGREDIENT	C9H2L21V7U	1
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	1
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	1
PHENYL TRIMETHICONE	INACTIVE INGREDIENT	DR0K5NOJ4R	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	1

Products#

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

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

Lip Balm
OCTINOXATE OXYBENZONE DIMETHICONE
OCTINOXATE
BUTYLATED HYDROXYANISOLE
BUTYLATED HYDROXYTOLUENE
MEDIUM-CHAIN TRIGLYCERIDES
LANOLIN
MINERAL OIL
PETROLATUM
PHENYL TRIMETHICONE
PROPYLPARABEN
OXYBENZONE
DIMETHICONE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
49852-202	49852-202-35, 49852-202-05

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
OCTINOXATE	4Y5P7MUD51	ACTIB
BUTYLATED HYDROXYANISOLE	REK4960K2U	IACT
BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	IACT
MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	IACT
LANOLIN	7EV65EAW6H	IACT
MINERAL OIL	T5L8T28FGP	IACT
PETROLATUM	4T6H12BN9U	IACT
PHENYL TRIMETHICONE	DR0K5NOJ4R	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT
OXYBENZONE	95OOS7VE0Y	ACTIB
DIMETHICONE	92RU3N3Y1O	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 4 · 199 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
MINERAL OIL	MINERAL OIL	T5L8T28FGP	GEL / TOPICAL	2.5 %w/w		Exact identifier — unii candidate 30 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDES	MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	POWDER, FOR SUSPENSION / ORAL	3390 mg/5ml		Exact identifier — unii candidate 18 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / INTRA-ARTICULAR	0.03 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDES	MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	SPRAY, METERED / SUBLINGUAL		110 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / INTRALESIONAL	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	LIQUID / ORAL		2 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	GEL / VAGINAL		2 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / SUBCUTANEOUS		2 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SPRAY / TOPICAL	0.8 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	PASTE / DENTAL	95 %w/w		Exact identifier — unii candidate 30 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SOLUTION, CONCENTRATE / ORAL	0.1 mg/1ml		Exact identifier — unii candidate 32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	TABLET, EXTENDED RELEASE / ORAL		1 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
BUTYLATED HYDROXYANISOLE	BUTYLATED HYDROXYANISOLE	REK4960K2U	SUPPOSITORY / RECTAL		1 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	CREAM / TOPICAL		2772 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / RECTAL	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	CREAM / VAGINAL		3 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDES	MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	SPRAY / TOPICAL		540 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	CREAM / VAGINAL		402 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	CAPSULE / VAGINAL	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	ELIXIR / ORAL	200 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / INTRAMUSCULAR	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
BUTYLATED HYDROXYANISOLE	BUTYLATED HYDROXYANISOLE	REK4960K2U	TABLET, EXTENDED RELEASE / ORAL		1 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	OINTMENT / AURICULAR (OTIC)	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SUSPENSION / AURICULAR (OTIC)	NA		Exact identifier — unii candidate 68 equally ranked IID candidates
BUTYLATED HYDROXYANISOLE	BUTYLATED HYDROXYANISOLE	REK4960K2U	TABLET / SUBLINGUAL		2 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	TABLET, FILM COATED / ORAL	NA		Exact identifier — unii candidate 30 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SOLUTION / ORAL		14 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	SOAP / TOPICAL	0.85 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	TABLET / SUBLINGUAL	0.13 mg		Exact identifier — unii candidate 32 equally ranked IID candidates
LANOLIN	LANOLIN	7EV65EAW6H	CREAM / TOPICAL		10 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
BUTYLATED HYDROXYANISOLE	BUTYLATED HYDROXYANISOLE	REK4960K2U	SUSPENSION / ORAL	2.5 mg/5ml		Exact identifier — unii candidate 24 equally ranked IID candidates
LANOLIN	LANOLIN	7EV65EAW6H	EMULSION / TOPICAL	0.25 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	GUM, CHEWING / BUCCAL		5 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	SUSPENSION / OPHTHALMIC	0.1 %w/w		Exact identifier — unii candidate 30 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	CAPSULE, EXTENDED RELEASE / ORAL	0.07 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	OINTMENT, AUGMENTED / TOPICAL	81.94 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDES	MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	TABLET / ORAL		2 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION/ DROPS / OPHTHALMIC	0.01 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 68 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	SUPPOSITORY / RECTAL	NA		Exact identifier — unii candidate 30 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDES	MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	SUSPENSION / ORAL		10170 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	FILM, EXTENDED RELEASE / TRANSDERMAL	34 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
BUTYLATED HYDROXYANISOLE	BUTYLATED HYDROXYANISOLE	REK4960K2U	GRANULE, FOR SUSPENSION / ORAL	NA		Exact identifier — unii candidate 24 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	TABLET / ORAL	113.75 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
BUTYLATED HYDROXYANISOLE	BUTYLATED HYDROXYANISOLE	REK4960K2U	CREAM / VAGINAL	0.03 %w/w		Exact identifier — unii candidate 24 equally ranked IID candidates
BUTYLATED HYDROXYANISOLE	BUTYLATED HYDROXYANISOLE	REK4960K2U	SYRUP / ORAL		1 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	OINTMENT / OPHTHALMIC	59.5 %w/w		Exact identifier — unii candidate 30 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	CAPSULE / ORAL		120 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	TABLET, EXTENDED RELEASE / ORAL	0.12 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SHAMPOO / TOPICAL	0.03 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
BUTYLATED HYDROXYANISOLE	BUTYLATED HYDROXYANISOLE	REK4960K2U	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	NA		Exact identifier — unii candidate 24 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SOAP / TOPICAL	0.02 %w/w		Exact identifier — unii candidate 32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	INJECTION / INTRAVENOUS	NA		Exact identifier — unii candidate 32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	AEROSOL, FOAM / TOPICAL		4 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	LOTION / TOPICAL	25 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDES	MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	LOTION / TOPICAL	7 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SPRAY / NASAL	0.2 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	FILM / BUCCAL	0.22 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
LANOLIN	LANOLIN	7EV65EAW6H	OINTMENT / OPHTHALMIC	3 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
BUTYLATED HYDROXYANISOLE	BUTYLATED HYDROXYANISOLE	REK4960K2U	TABLET / ORAL		8 mg	Exact identifier — unii candidate 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
f5b7726a-b83a-4df8-8642-d56ec01793c4			1261d499-c2e1-473b-8407-bd0d0cf1c52a	2010-02-12	Warnings	Exact identifier spl id: f5b7726a-b83a-4df8-8642-d56ec01793c4 spl set id: 1261d499-c2e1-473b-8407-bd0d0cf1c52a

Reported adverse events (FAERS/openFDA)#

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