LIP BALM

Manufacturer: J. A. Cosmetics U.S. INC | Shanghai J. A. Cosmetics Trading CO., LTD.
Effective date: 2014-06-10
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: legacy-cache
Hydrated at: 2026-08-02 01:36:02

Label at a glance#

ProductLIP BALM SPF 15

Active ingredientOCTINOXATE, OXYBENZONE

Label structure11 sections

Storage and handling

OTHER INFORMATION Protect the product in this container from excessive heat and direct sun. Store at room temperature 20°C - 25°C (68°F-77°F)

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients:

OCTINOXATE (7.5%)

OXYBENZONE (5%)

OTC - PURPOSE SECTION

Purpose:

SUNSCREEN

INDICATIONS & USAGE SECTION

Uses:

HELPS PREVENT SUNBURN

WARNINGS SECTION

Warning:

For external use only

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 to help preven sunburn, not skin cancer or skin aging.

OTC - WHEN USING SECTION

When Using This Product

KEEP OUT OF EYES. RINSE WITH WATER TO REMOVE.

OTC - ASK DOCTOR SECTION

Stop use and ask a doctor if

rash or irritation develops.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN.

IF SWALLOWED GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

DOSAGE & ADMINISTRATION SECTION

Directions:

APPLY LIBERALLY AS OFTEN AS NEEDED BEFORE SUN EXPOSURE.

REAPPLY AS NEEDED OR AFTER SWIMMING OR TOWEL DRYING.

Sun Protection Measures:

Spending time in the sun increases your risk of cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

Limit time in the sun, especially from 10 a.m. - 2 p.m.
Wear long-sleeved shirt, pants, hats and sunglasses
Children under 6 months of age: Ask doctor.

STORAGE AND HANDLING SECTION

OTHER INFORMATION

Protect the product in this container from excessive heat and direct sun.
Store at room temperature 20°C - 25°C (68°F-77°F)

INACTIVE INGREDIENT SECTION

Inactive Ingredient:

polybutene, paraffinum liquidum (mineral oil), paraffin, microcrystalline wax (cera microcristallina), cersin, caprylic/capric triglyceride, polyethylene, bis-diglyceryl polyacryladipate-2, butyrospermum parkii (shea) butter, mentha piperita (peppermint)oil, polyglyceryl-4 isostearate, tocopheryl acetate (VE), phenoxyethanol, methylparaben, ethylparaben, butylparaben, isobutylparaben, propylparaben

May Contain: MICA, TITANUM DIOXIDE (CI 77891), IRON OXIDES (CI 77491, CI 77492, CI 77499), YELLOW 6 LAKE (CI 15985), RED 27 LAKE (CI 45410), RED 6 LAKE (CI 15850), RED 40 LAKE (CI 16035)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

82601-06 LipSPF15 0321.ai

82601-06 LipSPF15 logo 0321.ai

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
76354-110-51	2019-12-24	C162847	48780-1	9855e2a2-5049-60a7-e053-dbdaa90a05bd	a0f6861c-33c8-4eed-897b-2747f2df8cb9
76354-110-51	2019-11-27	C162847	48780-1	9855e2a2-5049-60a7-e053-dbdaa90a05bd	a0f6861c-33c8-4eed-897b-2747f2df8cb9

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
ADIPIC ACID	INACTIVE INGREDIENT	76A0JE0FKJ	1
BUTYLPARABEN	INACTIVE INGREDIENT	3QPI1U3FV8	1
CERESIN	INACTIVE INGREDIENT	Q1LS2UJO3A	1
D&C RED NO. 27	INACTIVE INGREDIENT	2LRS185U6K	1
D&C RED NO. 6 BARIUM LAKE	INACTIVE INGREDIENT	K4XZD9W99K	1
ETHYLPARABEN	INACTIVE INGREDIENT	14255EXE39	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	1
HIGH DENSITY POLYETHYLENE	INACTIVE INGREDIENT	UG00KM4WR7	1
ISOBUTYLPARABEN	INACTIVE INGREDIENT	0QQJ25X58G	1
MEDIUM-CHAIN TRIGLYCERIDES	INACTIVE INGREDIENT	C9H2L21V7U	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	1
MICA	INACTIVE INGREDIENT	V8A1AW0880	1
MICROCRYSTALLINE WAX	INACTIVE INGREDIENT	XOF597Q3KY	1
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	1
PARAFFIN	INACTIVE INGREDIENT	I9O0E3H2ZE	1
PEPPERMINT OIL	INACTIVE INGREDIENT	AV092KU4JH	1
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	1
POLYBUTENE (1400 MW)	INACTIVE INGREDIENT	1NA5AO9GH7	1
POLYGLYCERYL-4 ISOSTEARATE	INACTIVE INGREDIENT	820DPX33S7	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	1
SHEA BUTTER	INACTIVE INGREDIENT	K49155WL9Y	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	1

Products#

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

DailyMed product names page 1 of 1 · 31 matching rows.

LIP BALM SPF 15
OCTINOXATE, OXYBENZONE
OCTINOXATE
OXYBENZONE
POLYBUTENE (1400 MW)
MINERAL OIL
PARAFFIN
MICROCRYSTALLINE WAX
CERESIN
MEDIUM-CHAIN TRIGLYCERIDES
HIGH DENSITY POLYETHYLENE
ADIPIC ACID
SHEA BUTTER
PEPPERMINT OIL
POLYGLYCERYL-4 ISOSTEARATE
.ALPHA.-TOCOPHEROL ACETATE
PHENOXYETHANOL
METHYLPARABEN
ETHYLPARABEN
BUTYLPARABEN
ISOBUTYLPARABEN
PROPYLPARABEN
MICA
TITANIUM DIOXIDE
FERRIC OXIDE RED
FERROSOFERRIC OXIDE
FERRIC OXIDE YELLOW
FD&C YELLOW NO. 6
D&C RED NO. 27
D&C RED NO. 6 BARIUM LAKE
FD&C RED NO. 40

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
76354-110	76354-110-41, 76354-110-51

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 29 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
OCTINOXATE	4Y5P7MUD51	ACTIB
OXYBENZONE	95OOS7VE0Y	ACTIB
POLYBUTENE (1400 MW)	1NA5AO9GH7	IACT
MINERAL OIL	T5L8T28FGP	IACT
PARAFFIN	I9O0E3H2ZE	IACT
MICROCRYSTALLINE WAX	XOF597Q3KY	IACT
CERESIN	Q1LS2UJO3A	IACT
MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	IACT
HIGH DENSITY POLYETHYLENE	UG00KM4WR7	IACT
ADIPIC ACID	76A0JE0FKJ	IACT
SHEA BUTTER	K49155WL9Y	IACT
PEPPERMINT OIL	AV092KU4JH	IACT
POLYGLYCERYL-4 ISOSTEARATE	820DPX33S7	IACT
.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	IACT
PHENOXYETHANOL	HIE492ZZ3T	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
ETHYLPARABEN	14255EXE39	IACT
BUTYLPARABEN	3QPI1U3FV8	IACT
ISOBUTYLPARABEN	0QQJ25X58G	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT
MICA	V8A1AW0880	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
FERRIC OXIDE RED	1K09F3G675	IACT
FERROSOFERRIC OXIDE	XM0M87F357	IACT
FERRIC OXIDE YELLOW	EX438O2MRT	IACT
FD&C YELLOW NO. 6	H77VEI93A8	IACT
D&C RED NO. 27	2LRS185U6K	IACT
D&C RED NO. 6 BARIUM LAKE	K4XZD9W99K	IACT
FD&C RED NO. 40	WZB9127XOA	IACT

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 8 · 442 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, SUSPENSION / SUBCUTANEOUS	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 20 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / OPHTHALMIC	0.05 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	LOTION / TOPICAL		140 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	SUSPENSION, EXTENDED RELEASE / ORAL	0.12 mg/5ml		Exact identifier — unii candidate 34 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / ORAL		346 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
PARAFFIN	PARAFFIN	I9O0E3H2ZE	CREAM / TOPICAL		300 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	CAPSULE / ORAL		7 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / INTRALESIONAL	0.15 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
HIGH DENSITY POLYETHYLENE	HIGH DENSITY POLYETHYLENE	UG00KM4WR7	PASTE / DENTAL		60 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / IONTOPHORESIS	0.1 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, EXTENDED RELEASE / ORAL		1 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	GRANULE, FOR SUSPENSION / ORAL		143 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
FERROSOFERRIC OXIDE	FERROSOFERRIC OXIDE	XM0M87F357	POWDER, FOR SUSPENSION / ORAL	NA		Exact identifier — unii candidate 10 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	OINTMENT / TOPICAL		29 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	3.6 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	GRANULE, FOR SUSPENSION / ORAL		11 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	CAPSULE, COATED PELLETS / ORAL	NA		Exact identifier — unii candidate 34 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET / ORAL		232 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	TABLET / SUBLINGUAL	1 mg		Exact identifier — unii candidate 20 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	DROPS / AURICULAR (OTIC)	0.01 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	TABLET, COATED / ORAL	0.8 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	SUSPENSION / ORAL		113 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	CAPSULE / ORAL		120 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDES	MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	TABLET / ORAL		2 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	LOTION / TOPICAL	NA		Exact identifier — unii candidate 21 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	TABLET, DELAYED RELEASE / ORAL		37 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	TABLET / BUCCAL	0.4 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	SPONGE / TOPICAL	0.01 %w/w		Exact identifier — unii candidate 34 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	GRANULE, FOR SUSPENSION / ORAL		80 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	TABLET, EXTENDED RELEASE / ORAL		8 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
MICROCRYSTALLINE WAX	MICROCRYSTALLINE WAX	XOF597Q3KY	GEL / TOPICAL	NA		Exact identifier — unii candidate 4 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	SOLUTION / RECTAL	0.5 %w/v		Exact identifier — unii candidate 34 equally ranked IID candidates
PEPPERMINT OIL	PEPPERMINT OIL	AV092KU4JH	SOLUTION / DENTAL	0.04 %v/v		Exact identifier — unii candidate 21 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		42 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	FILM, EXTENDED RELEASE / TRANSDERMAL	34 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
HIGH DENSITY POLYETHYLENE	HIGH DENSITY POLYETHYLENE	UG00KM4WR7	CAPSULE / ORAL	10 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUSPENSION / TOPICAL	0.24 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 40 equally ranked IID candidates
PARAFFIN	PARAFFIN	I9O0E3H2ZE	AEROSOL, FOAM / TOPICAL		14235 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
HIGH DENSITY POLYETHYLENE	HIGH DENSITY POLYETHYLENE	UG00KM4WR7	SUPPOSITORY / RECTAL	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, COATED / ORAL		17 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
HIGH DENSITY POLYETHYLENE	HIGH DENSITY POLYETHYLENE	UG00KM4WR7	TABLET, DELAYED RELEASE / ORAL	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
FERROSOFERRIC OXIDE	FERROSOFERRIC OXIDE	XM0M87F357	CAPSULE, EXTENDED RELEASE / ORAL	1.49 mg		Exact identifier — unii candidate 10 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	TABLET, CHEWABLE / ORAL	0.41 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
POLYBUTENE (1400 MW)	POLYBUTENE (1400 MW)	1NA5AO9GH7	FILM, EXTENDED RELEASE / TRANSDERMAL	NA		Exact identifier — unii candidate 2 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	CREAM, AUGMENTED / TOPICAL		2 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	CREAM / VAGINAL		3 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	DROPS / OPHTHALMIC	0.01 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SYRUP / ORAL		40 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / INTRA-ARTICULAR	0.03 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
FERROSOFERRIC OXIDE	FERROSOFERRIC OXIDE	XM0M87F357	CAPSULE, COATED / ORAL	0.11 mg		Exact identifier — unii candidate 10 equally ranked IID candidates
PEPPERMINT OIL	PEPPERMINT OIL	AV092KU4JH	SHAMPOO / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 21 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / INFILTRATION		80 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	OINTMENT / OPHTHALMIC	0.05 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / NASAL	250 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / INTRAMUSCULAR	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SUSPENSION / SUBCUTANEOUS	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	POWDER / RESPIRATORY (INHALATION)	0.04 mg		Exact identifier — unii candidate 20 equally ranked IID candidates
BUTYLPARABEN	BUTYLPARABEN	3QPI1U3FV8	SUSPENSION / ORAL		12 mg	Exact identifier — unii candidate 15 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
5d8f0093-152a-4fa9-9c3a-3e132d940dde			a0f6861c-33c8-4eed-897b-2747f2df8cb9	2014-06-10	Warnings	Exact identifier spl set id: a0f6861c-33c8-4eed-897b-2747f2df8cb9

Reported adverse events (FAERS/openFDA)#

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