LIP BALM

Manufacturer: Kamins Dermatologics Inc. | Odan Laboratories Ltd
Effective date: 2022-12-01
Label type: HUMAN OTC DRUG LABEL
Version: 11
Source: legacy-cache
Hydrated at: 2026-08-01 21:45:51

Label at a glance#

ProductLIP BALM

Active ingredientOCTINOXATE, OXYBENZONE, ZINC OXIDE

Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients:

OCTINOXATE 7.5%

OXYBENZONE 5.0%

ZINC OXIDE 4.0%

OTC - PURPOSE SECTION

Purpose: Sunscreen product

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children.

INDICATIONS & USAGE SECTION

A soothing treatment balm that helps heal and protect lips from sun, wind and extreme tempera- tures. Repairs happed, sore lips with Bio-MapleTM compound and skin softening oils. Also helps prevent the breakout of lip sores with broad spectrum UVA/UVB sun screening agents. Creates a smoother palette for lipstick application by diminishing the appearance of lip lines and reducing the feathering of lip color. Use anytime for fuller, more luscious lips

Uses

helps prevent sunburn

higher SPF gives more sunburn protection

provides moderate protection against sunburn

WARNINGS SECTION

Warnings

For external use only.

When using this product, keep out of eyes. If contact occurs, rinse abundantly with water to remove.

Stop use and ask a doctor if rash or irritation develops and lasts.

If swallowed, seek medical assistance or contact a Poison Control Center immediately.

Sun alert: limiting sun exposure, earing protective clothing and using sunscreens may reduce the risks of skin aging, skin cancer and other harmful effects of the sun.

DOSAGE & ADMINISTRATION SECTION

Directions

Using the angled tube applicator, squeeze tube and apply directly to lips 15-30 minutes before sun exposure. Reapply as needed, especially after prolonged sun exposure, drinking or eating.

Children under 6 months of age: ask a doctor.

INACTIVE INGREDIENT SECTION

Inactive ingredients: Polybutene, ricinus communis (castor) seed oil, petrolatum, VP/hexadecene copolymer, cera alba (beeswax), cyclopentasiloxane/dimethicone crosspolymer, caprylic/capric triglyceride, squalane, copernicia cerifera (carnauba wax), paraffin, tocopheryl acetate, acer saccharum (maple isolate), flavour/aroma, benzyl benzoate.

B. KAMINS LIP BALM SPF 20 box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Lip Balm Package Label BoxB. KAMINS
LIP BALM SPF 20
15 G / 0.5 oz
DIN 02248084

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
OCTINOXATE	ACTIVE INGREDIENT	4Y5P7MUD51	3
OXYBENZONE	ACTIVE INGREDIENT	95OOS7VE0Y	3
ZINC OXIDE	ACTIVE INGREDIENT	SOI2LOH54Z	3
OCTINOXATE	ACTIVE MOIETY	4Y5P7MUD51	3
OXYBENZONE	ACTIVE MOIETY	95OOS7VE0Y	3
ZINC OXIDE	ACTIVE MOIETY	SOI2LOH54Z	3
1-HEXADECENE	INACTIVE INGREDIENT	97T015M2UX	3
ACER SACCHARUM SAP	INACTIVE INGREDIENT	75UOH57984	3
ALPHA-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	3
BENZYL BENZOATE	INACTIVE INGREDIENT	N863NB338G	3
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	3
CASTOR OIL	INACTIVE INGREDIENT	D5340Y2I9G	3
CYCLOMETHICONE 5	INACTIVE INGREDIENT	0THT5PCI0R	3
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	3
PARAFFIN	INACTIVE INGREDIENT	I9O0E3H2ZE	3
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	3
POLYBUTENE (1400 MW)	INACTIVE INGREDIENT	1NA5AO9GH7	3
SQUALANE	INACTIVE INGREDIENT	GW89575KF9	3
TRICAPRIN	INACTIVE INGREDIENT	O1PB8EU98M	3
TRICAPRYLIN	INACTIVE INGREDIENT	6P92858988	3
WHITE WAX	INACTIVE INGREDIENT	7G1J5DA97F	3

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

LIP BALM
OCTINOXATE OXYBENZONE ZINC OXIDE
POLYBUTENE (1400 MW)
CASTOR OIL
PETROLATUM
1-HEXADECENE
WHITE WAX
CYCLOMETHICONE 5
DIMETHICONE
TRICAPRIN
TRICAPRYLIN
SQUALANE
CARNAUBA WAX
PARAFFIN
ALPHA-TOCOPHEROL ACETATE
ACER SACCHARUM SAP
BENZYL BENZOATE
OCTINOXATE
OXYBENZONE
ZINC OXIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
63550-114	63550-114-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
POLYBUTENE (1400 MW)	1NA5AO9GH7	IACT
CASTOR OIL	D5340Y2I9G	IACT
PETROLATUM	4T6H12BN9U	IACT
1-HEXADECENE	97T015M2UX	IACT
WHITE WAX	7G1J5DA97F	IACT
CYCLOMETHICONE 5	0THT5PCI0R	IACT
DIMETHICONE	92RU3N3Y1O	IACT
TRICAPRIN	O1PB8EU98M	IACT
TRICAPRYLIN	6P92858988	IACT
SQUALANE	GW89575KF9	IACT
CARNAUBA WAX	R12CBM0EIZ	IACT
PARAFFIN	I9O0E3H2ZE	IACT
ALPHA-TOCOPHEROL ACETATE	9E8X80D2L0	IACT
ACER SACCHARUM SAP	75UOH57984	IACT
BENZYL BENZOATE	N863NB338G	IACT
OCTINOXATE	4Y5P7MUD51	ACTIB
OXYBENZONE	95OOS7VE0Y	ACTIB
ZINC OXIDE	SOI2LOH54Z	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
WHITE WAX	WHITE WAX	7G1J5DA97F	TABLET / ORAL	5 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
CASTOR OIL	CASTOR OIL	D5340Y2I9G	TABLET / SUBLINGUAL	1.6 mg		Exact identifier — unii candidate 16 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	CAPSULE / VAGINAL	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
SQUALANE	SQUALANE	GW89575KF9	POWDER / ORAL	0.02 mg		Exact identifier — unii candidate 5 equally ranked IID candidates
WHITE WAX	WHITE WAX	7G1J5DA97F	OINTMENT, AUGMENTED / TOPICAL		429 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
BENZYL BENZOATE	BENZYL BENZOATE	N863NB338G	INJECTION, SOLUTION / INTRAMUSCULAR		750 mg	Exact identifier — unii candidate 4 equally ranked IID candidates
TRICAPRYLIN	TRICAPRILIN	6P92858988	INJECTION, SUSPENSION, LIPOSOMAL / EPIDURAL		1 mg	Exact identifier — unii candidate 2 equally ranked IID candidates
ALPHA-TOCOPHEROL ACETATE	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	TABLET / ORAL	0.5 mg		Exact identifier — unii candidate 3 equally ranked IID candidates
WHITE WAX	WHITE WAX	7G1J5DA97F	TABLET, FILM COATED / ORAL	0.2 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	TABLET, EXTENDED RELEASE / ORAL	0.18 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
CASTOR OIL	CASTOR OIL	D5340Y2I9G	SOLUTION / TOPICAL	1.38 %w/w		Exact identifier — unii candidate 16 equally ranked IID candidates
PARAFFIN	PARAFFIN	I9O0E3H2ZE	SUSPENSION / TOPICAL		11726 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
SQUALANE	SQUALANE	GW89575KF9	CREAM, AUGMENTED / TOPICAL		120 mg	Exact identifier — unii candidate 5 equally ranked IID candidates
WHITE WAX	WHITE WAX	7G1J5DA97F	CAPSULE / ORAL		79 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
CASTOR OIL	CASTOR OIL	D5340Y2I9G	TABLET, DELAYED RELEASE / ORAL	0.01 mg		Exact identifier — unii candidate 16 equally ranked IID candidates
BENZYL BENZOATE	BENZYL BENZOATE	N863NB338G	INJECTION / INTRAMUSCULAR		1500 mg	Exact identifier — unii candidate 4 equally ranked IID candidates
SQUALANE	SQUALANE	GW89575KF9	SOLUTION / TOPICAL	1 %w/w		Exact identifier — unii candidate 5 equally ranked IID candidates
CASTOR OIL	CASTOR OIL	D5340Y2I9G	OINTMENT / TOPICAL	14.9 %w/w		Exact identifier — unii candidate 16 equally ranked IID candidates
CASTOR OIL	CASTOR OIL	D5340Y2I9G	INJECTION / INTRAMUSCULAR		885 mg	Exact identifier — unii candidate 16 equally ranked IID candidates
PARAFFIN	PARAFFIN	I9O0E3H2ZE	TABLET, COATED / ORAL	0.07 mg		Exact identifier — unii candidate 11 equally ranked IID candidates
ALPHA-TOCOPHEROL ACETATE	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	FILM / BUCCAL	0.09 mg		Exact identifier — unii candidate 3 equally ranked IID candidates
CARNAUBA WAX	CARNAUBA WAX	R12CBM0EIZ	CAPSULE, EXTENDED RELEASE / ORAL		288 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	AEROSOL, FOAM / TOPICAL	7.9 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	SUPPOSITORY / VAGINAL	27 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
CARNAUBA WAX	CARNAUBA WAX	R12CBM0EIZ	TABLET / ORAL	167.8 mg		Exact identifier — unii candidate 11 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	CREAM / TOPICAL		4213 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	SPONGE / TOPICAL	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
PARAFFIN	PARAFFIN	I9O0E3H2ZE	TABLET, EXTENDED RELEASE / ORAL		321 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	OINTMENT, AUGMENTED / TOPICAL	81.94 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
CASTOR OIL	CASTOR OIL	D5340Y2I9G	TABLET, FILM COATED / ORAL	15.29 mg		Exact identifier — unii candidate 16 equally ranked IID candidates
WHITE WAX	WHITE WAX	7G1J5DA97F	CREAM, AUGMENTED / TOPICAL	10 %w/w		Exact identifier — unii candidate 15 equally ranked IID candidates
BENZYL BENZOATE	BENZYL BENZOATE	N863NB338G	SOLUTION / INTRAMUSCULAR		447 mg	Exact identifier — unii candidate 4 equally ranked IID candidates
WHITE WAX	WHITE WAX	7G1J5DA97F	TABLET, COATED / ORAL	3 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
WHITE WAX	WHITE WAX	7G1J5DA97F	CREAM / TOPICAL		500 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	SOAP / TOPICAL	0.85 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
ALPHA-TOCOPHEROL ACETATE	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	CAPSULE / ORAL	2 mg		Exact identifier — unii candidate 3 equally ranked IID candidates
CASTOR OIL	CASTOR OIL	D5340Y2I9G	EMULSION / OPHTHALMIC		32 mg	Exact identifier — unii candidate 16 equally ranked IID candidates
CASTOR OIL	CASTOR OIL	D5340Y2I9G	GRANULE, FOR SUSPENSION / ORAL		128 mg	Exact identifier — unii candidate 16 equally ranked IID candidates
PARAFFIN	PARAFFIN	I9O0E3H2ZE	OINTMENT / RECTAL		38 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
WHITE WAX	WHITE WAX	7G1J5DA97F	OINTMENT / TOPICAL		2100 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
SQUALANE	SQUALANE	GW89575KF9	AEROSOL, FOAM / TOPICAL	2.23 %w/w		Exact identifier — unii candidate 5 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	LIQUID / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	CREAM, AUGMENTED / TOPICAL	26 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
CASTOR OIL	CASTOR OIL	D5340Y2I9G	GEL / NASAL		429 mg	Exact identifier — unii candidate 16 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	OINTMENT / OPHTHALMIC	88.4 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
CYCLOMETHICONE 5	CYCLOMETHICONE 5	0THT5PCI0R	AEROSOL, FOAM / TOPICAL		144 mg	Exact identifier — unii candidate 3 equally ranked IID candidates
CARNAUBA WAX	CARNAUBA WAX	R12CBM0EIZ	GUM, CHEWING / BUCCAL		10 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
CARNAUBA WAX	CARNAUBA WAX	R12CBM0EIZ	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii candidate 11 equally ranked IID candidates
CYCLOMETHICONE 5	CYCLOMETHICONE 5	0THT5PCI0R	AEROSOL / TOPICAL	2.5 %w/w		Exact identifier — unii candidate 3 equally ranked IID candidates
CARNAUBA WAX	CARNAUBA WAX	R12CBM0EIZ	TABLET, EXTENDED RELEASE / ORAL		2150 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	CAPSULE, EXTENDED RELEASE / ORAL	0.07 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
CASTOR OIL	CASTOR OIL	D5340Y2I9G	TABLET, EXTENDED RELEASE / ORAL	23.27 mg		Exact identifier — unii candidate 16 equally ranked IID candidates
BENZYL BENZOATE	BENZYL BENZOATE	N863NB338G	CAPSULE / ORAL	NA		Exact identifier — unii candidate 4 equally ranked IID candidates
PARAFFIN	PARAFFIN	I9O0E3H2ZE	CREAM / TOPICAL		300 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
CARNAUBA WAX	CARNAUBA WAX	R12CBM0EIZ	OINTMENT / TOPICAL	NA		Exact identifier — unii candidate 11 equally ranked IID candidates
WHITE WAX	WHITE WAX	7G1J5DA97F	TABLET, EXTENDED RELEASE / ORAL	14 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
CARNAUBA WAX	CARNAUBA WAX	R12CBM0EIZ	TABLET, FILM COATED / ORAL		1 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
WHITE WAX	WHITE WAX	7G1J5DA97F	CAPSULE, EXTENDED RELEASE / ORAL		71 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	OINTMENT / AURICULAR (OTIC)	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
WHITE WAX	WHITE WAX	7G1J5DA97F	LOTION / TOPICAL	1 %w/w		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
adf58bb4-2772-4488-9360-c4b664e611b5			f2db718b-5691-45fc-9457-7ca54336e4bf	2024-06-10	Warnings	Exact identifier spl set id: f2db718b-5691-45fc-9457-7ca54336e4bf

Reported adverse events (FAERS/openFDA)#

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