Cotz Lip Balm

Manufacturer: Fallien Cosmeceuticals, LTD. | Custom Analytics LLC | Process Technologies & Packaging
Effective date: 2012-12-28
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 22:34:12

Label at a glance#

ProductCotz Lip Balm Lip Balm/Sunscreen

Active ingredientTitanium Dioxide, Zinc Oxide

Label structure9 sections

Indications and uses

Helps prevent sunburn. If used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun.

Dosage and administration

Apply liberally 15 minutes before sun exposure. Reapply: After 80 minutes of swimming or sweating Immediately after towel drying At least every 2 hours Children under 6 months: Ask a doctor Sun Protection Measures: Spending time in the sun increases your risk of skin 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 protectio...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

DRUG FACTS

Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 4.0%

Zinc Oxide 5.5%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses:

INDICATIONS & USAGE SECTION

Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings:

WARNINGS SECTION

For external use only.

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin.

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs.

OTC - WHEN USING SECTION

When using this product, keep out of eyes. Rinse with water to remove.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children, if swallowed, get medical help or contact a Poison Control Center right away.

Directions:

DOSAGE & ADMINISTRATION SECTION

Apply liberally 15 minutes before sun exposure.
Reapply:
- After 80 minutes of swimming or sweating
- Immediately after towel drying
- At least every 2 hours
Children under 6 months: Ask a doctor
Sun Protection Measures: Spending time in the sun increases your risk of skin 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 10:00 a.m.-2 p.m.
- Wear long-sleeved shirts, pants, hats, and sunglasses

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Alumina, Aluminum Hydroxide, Aluminum Stearate, Ascorbic Add, Ascorbyl Palmitate, C_12-15Alkyl Benzoate, Cetearyl Isononanoate, Cetyl PEG/PPG-15/15 Butyl Ether Dimethicone, Citric Add, Dipropylene Glycol Dicaprylate-Caprate, Ethylhexyl Palmitate, Flavor, Helianthus Annuus (Sunflower) Seed Wax, Hexyldecanol, Hexyldecyl Laurate, Iron Oxide, Lecithin, Ozokerite, PEG-8, Polyglyceryl-3 Diisostearate, Polyhydroxystearic Acid, Stearic Acid, Tocopherol, Tocopheryl Acetate, Zingiber Officinale (Ginger) Root Oil

Other Information:

SPL UNCLASSIFIED SECTION

Protect this product from excessive heat and direct sun
May stain some fabrics

Principal Display Panel – 4.5 g Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CoTZ^®

LIP BALM

The Healthier Lip Balm^TM

100% Free of:

Chemical Sunscreens, Oils,

Lanolin, Gluten

SPF45

Broad

Spectrum

UVA-UVB

WATER RESISTANT

(80 MINUTES)

Net Wt. .14 oz/4.5 g

Principal Display Panel – 4.5 g Carton Label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c5cd4727-ac49-4409-82b1-5bd8006c3ec7	Product name	1	20171122

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
58892-126-87	2019-11-27	C162847	48780-1	9855d018-dead-cd31-e053-dbdaa90ab51a	a3345cf5-5e48-4052-b5c2-65633869de5a

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
58892-126-87	Cotz Lip Balm Lip Balm/Sunscreen	4.5 g in 1 TUBE	LIPSTICK	4.5		2
58892-126-87	Cotz Lip Balm Lip Balm/Sunscreen	1 in 1 CARTON	LIPSTICK	1		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58892-126	COTZ LIP BALM LIP BALM/SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) LIPSTICK [FALLIEN COSMECEUTICALS, LTD.]	2	Legacy NDC, 2 package rows	20130109_a3345cf5-5e48-4052-b5c2-65633869de5a.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Titanium Dioxide	ACTIVE INGREDIENT	15FIX9V2JP	2
Zinc Oxide	ACTIVE INGREDIENT	SOI2LOH54Z	2
Titanium Dioxide	ACTIVE MOIETY	15FIX9V2JP	2
Zinc Oxide	ACTIVE MOIETY	SOI2LOH54Z	2
.Alpha.-Tocopherol	INACTIVE INGREDIENT	H4N855PNZ1	2
.ALPHA.-Tocopherol Acetate, D-	INACTIVE INGREDIENT	A7E6112E4N	2
Aluminum Hydroxide	INACTIVE INGREDIENT	5QB0T2IUN0	2
Aluminum Oxide	INACTIVE INGREDIENT	LMI26O6933	2
Aluminum Stearate	INACTIVE INGREDIENT	U6XF9NP8HM	2
Anhydrous Citric Acid	INACTIVE INGREDIENT	XF417D3PSL	2
Ascorbic Acid	INACTIVE INGREDIENT	PQ6CK8PD0R	2
Ascorbyl Palmitate	INACTIVE INGREDIENT	QN83US2B0N	2
C12-15 Alkyl Benzoate	INACTIVE INGREDIENT	A9EJ3J61HQ	2
Ceresin	INACTIVE INGREDIENT	Q1LS2UJO3A	2
Cetearyl Isononanoate	INACTIVE INGREDIENT	P5O01U99NI	2
Ethylhexyl Palmitate	INACTIVE INGREDIENT	2865993309	2
Ferric Oxide Red	INACTIVE INGREDIENT	1K09F3G675	2
Ginger Oil	INACTIVE INGREDIENT	SAS9Z1SVUK	2
Hexyldecanol	INACTIVE INGREDIENT	151Z7P1317	2
Hexyldecyl Laurate	INACTIVE INGREDIENT	0V595C1P6M	2
Kiwi Fruit	INACTIVE INGREDIENT	71ES77LGJC	2
Lecithin, Soybean	INACTIVE INGREDIENT	1DI56QDM62	2
Lime (Citrus)	INACTIVE INGREDIENT	8CZS546954	2
Polyethylene Glycol 400	INACTIVE INGREDIENT	B697894SGQ	2
Propylene Glycol Dicaprylate/Dicaprate	INACTIVE INGREDIENT	O4446S9CRA	2
Stearic Acid	INACTIVE INGREDIENT	4ELV7Z65AP	2
Sunflower Oil	INACTIVE INGREDIENT	3W1JG795YI	2

Products#

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

DailyMed product names page 1 of 1 · 27 matching rows.

Cotz Lip Balm Lip Balm/Sunscreen
Titanium Dioxide, Zinc Oxide
Titanium Dioxide
Zinc Oxide
Aluminum Oxide
Aluminum Hydroxide
Aluminum Stearate
Ascorbic Acid
Ascorbyl Palmitate
C12-15 Alkyl Benzoate
Ceresin
Cetearyl Isononanoate
Anhydrous Citric Acid
Propylene Glycol Dicaprylate/Dicaprate
Ethylhexyl Palmitate
Kiwi Fruit
Lime (Citrus)
Sunflower Oil
Hexyldecanol
Hexyldecyl Laurate
Ferric Oxide Red
Lecithin, Soybean
Polyethylene Glycol 400
Stearic Acid
.Alpha.-Tocopherol
.ALPHA.-Tocopherol Acetate, D-
Ginger Oil

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
58892-126	58892-126-87

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Titanium Dioxide	15FIX9V2JP	ACTIB
Zinc Oxide	SOI2LOH54Z	ACTIB
Aluminum Oxide	LMI26O6933	IACT
Aluminum Hydroxide	5QB0T2IUN0	IACT
Aluminum Stearate	U6XF9NP8HM	IACT
Ascorbic Acid	PQ6CK8PD0R	IACT
Ascorbyl Palmitate	QN83US2B0N	IACT
C12-15 Alkyl Benzoate	A9EJ3J61HQ	IACT
Ceresin	Q1LS2UJO3A	IACT
Cetearyl Isononanoate	P5O01U99NI	IACT
Anhydrous Citric Acid	XF417D3PSL	IACT
Propylene Glycol Dicaprylate/Dicaprate	O4446S9CRA	IACT
Ethylhexyl Palmitate	2865993309	IACT
Kiwi Fruit	71ES77LGJC	IACT
Lime (Citrus)	8CZS546954	IACT
Sunflower Oil	3W1JG795YI	IACT
Hexyldecanol	151Z7P1317	IACT
Hexyldecyl Laurate	0V595C1P6M	IACT
Ferric Oxide Red	1K09F3G675	IACT
Lecithin, Soybean	1DI56QDM62	IACT
Polyethylene Glycol 400	B697894SGQ	IACT
Stearic Acid	4ELV7Z65AP	IACT
.Alpha.-Tocopherol	H4N855PNZ1	IACT
.ALPHA.-Tocopherol Acetate, D-	A7E6112E4N	IACT
Ginger Oil	SAS9Z1SVUK	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 4 · 205 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
Anhydrous Citric Acid	ANHYDROUS CITRIC ACID	XF417D3PSL	CLOTH / TOPICAL	4.2 mg		Exact identifier — unii candidate 61 equally ranked IID candidates
Anhydrous Citric Acid	ANHYDROUS CITRIC ACID	XF417D3PSL	SPRAY / NASAL		5 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
Anhydrous Citric Acid	ANHYDROUS CITRIC ACID	XF417D3PSL	INJECTION, SOLUTION / INTRAMUSCULAR		25 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
.Alpha.-Tocopherol	.ALPHA.-TOCOPHEROL	H4N855PNZ1	TABLET, EXTENDED RELEASE / ORAL		4 mg	Exact identifier — unii candidate 10 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	GEL / VAGINAL		1250 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
Stearic Acid	STEARIC ACID	4ELV7Z65AP	TABLET, CHEWABLE / ORAL		180 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
Ascorbic Acid	ASCORBIC ACID	PQ6CK8PD0R	GEL / TOPICAL		7 mg	Exact identifier — unii candidate 25 equally ranked IID candidates
Anhydrous Citric Acid	ANHYDROUS CITRIC ACID	XF417D3PSL	INJECTION / SUBCUTANEOUS		101 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
Stearic Acid	STEARIC ACID	4ELV7Z65AP	IMPLANT / SUBCUTANEOUS	1.04 mg		Exact identifier — unii candidate 26 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	AEROSOL, POWDER / TOPICAL	NA		Exact identifier — unii candidate 36 equally ranked IID candidates
Stearic Acid	STEARIC ACID	4ELV7Z65AP	OINTMENT / TOPICAL	15 %w/w		Exact identifier — unii candidate 26 equally ranked IID candidates
Anhydrous Citric Acid	ANHYDROUS CITRIC ACID	XF417D3PSL	CAPSULE, LIQUID FILLED / ORAL		360 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
Ascorbyl Palmitate	ASCORBYL PALMITATE	QN83US2B0N	SOLUTION / TOPICAL	NA		Exact identifier — unii candidate 6 equally ranked IID candidates
Anhydrous Citric Acid	ANHYDROUS CITRIC ACID	XF417D3PSL	POWDER, FOR SUSPENSION / ORAL		570 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	CAPSULE, DELAYED RELEASE / ORAL		26 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
Lecithin, Soybean	SOYBEAN LECITHIN	1DI56QDM62	TABLET, FILM COATED / ORAL	0.33 mg		Exact identifier — unii candidate 7 equally ranked IID candidates
Ascorbic Acid	ASCORBIC ACID	PQ6CK8PD0R	SOLUTION / RESPIRATORY (INHALATION)	0.04 %w/w		Exact identifier — unii candidate 25 equally ranked IID candidates
Ascorbic Acid	ASCORBIC ACID	PQ6CK8PD0R	POWDER, FOR SOLUTION / ORAL		560 mg	Exact identifier — unii candidate 25 equally ranked IID candidates
Anhydrous Citric Acid	ANHYDROUS CITRIC ACID	XF417D3PSL	SPRAY / TOPICAL	0.01 %w/w		Exact identifier — unii candidate 61 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	SOLUTION / ORAL		70200 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	SOLUTION/ DROPS / OPHTHALMIC	1 %w/v		Exact identifier — unii candidate 36 equally ranked IID candidates
.Alpha.-Tocopherol	.ALPHA.-TOCOPHEROL	H4N855PNZ1	FILM, SOLUBLE / BUCCAL	0.07 mg		Exact identifier — unii candidate 10 equally ranked IID candidates
Stearic Acid	STEARIC ACID	4ELV7Z65AP	PELLET / SUBCUTANEOUS	0.97 mg		Exact identifier — unii candidate 26 equally ranked IID candidates
Ferric Oxide Red	FERRIC OXIDE RED	1K09F3G675	CAPSULE, DELAYED RELEASE / ORAL		14 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
Anhydrous Citric Acid	ANHYDROUS CITRIC ACID	XF417D3PSL	SUSPENSION, EXTENDED RELEASE / ORAL		62 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
Ferric Oxide Red	FERRIC OXIDE RED	1K09F3G675	SUSPENSION, EXTENDED RELEASE / ORAL	2.7 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
Ferric Oxide Red	FERRIC OXIDE RED	1K09F3G675	CAPSULE, COATED PELLETS / ORAL	2 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
Anhydrous Citric Acid	ANHYDROUS CITRIC ACID	XF417D3PSL	GEL / TOPICAL		3 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
Stearic Acid	STEARIC ACID	4ELV7Z65AP	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		120 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
.Alpha.-Tocopherol	.ALPHA.-TOCOPHEROL	H4N855PNZ1	OINTMENT / TOPICAL	NA		Exact identifier — unii candidate 10 equally ranked IID candidates
Stearic Acid	STEARIC ACID	4ELV7Z65AP	POWDER, FOR SUSPENSION / ORAL	1203 mg/5ml		Exact identifier — unii candidate 26 equally ranked IID candidates
Ascorbic Acid	ASCORBIC ACID	PQ6CK8PD0R	TABLET, FILM COATED / ORAL	20 mg		Exact identifier — unii candidate 25 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
.Alpha.-Tocopherol	.ALPHA.-TOCOPHEROL	H4N855PNZ1	SOLUTION / ORAL	1.05 mg/1ml		Exact identifier — unii candidate 10 equally ranked IID candidates
Anhydrous Citric Acid	ANHYDROUS CITRIC ACID	XF417D3PSL	INJECTION, SOLUTION / INTRAVENOUS		772 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
Ferric Oxide Red	FERRIC OXIDE RED	1K09F3G675	CAPSULE, EXTENDED RELEASE / ORAL		5 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
Anhydrous Citric Acid	ANHYDROUS CITRIC ACID	XF417D3PSL	SHAMPOO / TOPICAL	0.07 %w/w		Exact identifier — unii candidate 61 equally ranked IID candidates
Anhydrous Citric Acid	ANHYDROUS CITRIC ACID	XF417D3PSL	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		12 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
Anhydrous Citric Acid	ANHYDROUS CITRIC ACID	XF417D3PSL	TABLET / ORAL		197 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
Lecithin, Soybean	SOYBEAN LECITHIN	1DI56QDM62	TABLET, EXTENDED RELEASE / ORAL		20 mg	Exact identifier — unii candidate 7 equally ranked IID candidates
Anhydrous Citric Acid	ANHYDROUS CITRIC ACID	XF417D3PSL	INJECTION / INTRAVENOUS		1152 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	TABLET, FILM COATED / ORAL	20 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
Ascorbic Acid	ASCORBIC ACID	PQ6CK8PD0R	SOLUTION / TOPICAL	0.04 %w/w		Exact identifier — unii candidate 25 equally ranked IID candidates
Ascorbic Acid	ASCORBIC ACID	PQ6CK8PD0R	SUPPOSITORY / RECTAL	3 mg		Exact identifier — unii candidate 25 equally ranked IID candidates
Ceresin	CERESIN	Q1LS2UJO3A	OINTMENT / TOPICAL		1097 mg	Exact identifier — unii candidate 2 equally ranked IID candidates
Ascorbic Acid	ASCORBIC ACID	PQ6CK8PD0R	TABLET, ORALLY DISINTEGRATING / ORAL	2.35 mg		Exact identifier — unii candidate 25 equally ranked IID candidates
Ferric Oxide Red	FERRIC OXIDE RED	1K09F3G675	TABLET / ORAL		8 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
.Alpha.-Tocopherol	.ALPHA.-TOCOPHEROL	H4N855PNZ1	TABLET / ORAL		2 mg	Exact identifier — unii candidate 10 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	TABLET, EXTENDED RELEASE / ORAL		60 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
Stearic Acid	STEARIC ACID	4ELV7Z65AP	SOLUTION / TOPICAL	NA		Exact identifier — unii candidate 26 equally ranked IID candidates
Stearic Acid	STEARIC ACID	4ELV7Z65AP	TABLET, FILM COATED / ORAL		176 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
Stearic Acid	STEARIC ACID	4ELV7Z65AP	TABLET, COATED / ORAL	42.4 mg		Exact identifier — unii candidate 26 equally ranked IID candidates
Lecithin, Soybean	SOYBEAN LECITHIN	1DI56QDM62	AEROSOL, METERED / RESPIRATORY (INHALATION)	0.1 %w/w		Exact identifier — unii candidate 7 equally ranked IID candidates
Aluminum Stearate	ALUMINUM STEARATE	U6XF9NP8HM	OINTMENT / TOPICAL	0.01 %w/w		Exact identifier — unii candidate 5 equally ranked IID candidates
Anhydrous Citric Acid	ANHYDROUS CITRIC ACID	XF417D3PSL	SOLUTION, CONCENTRATE / INTRAVENOUS		60 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
Anhydrous Citric Acid	ANHYDROUS CITRIC ACID	XF417D3PSL	SPRAY, METERED / NASAL	1.2 mg/1ml		Exact identifier — unii candidate 61 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	FILM, SOLUBLE / ORAL		29 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	OINTMENT / TOPICAL		1950 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
Ascorbic Acid	ASCORBIC ACID	PQ6CK8PD0R	TABLET / ORAL		80 mg	Exact identifier — unii candidate 25 equally ranked IID candidates
Ferric Oxide Red	FERRIC OXIDE RED	1K09F3G675	TABLET, EXTENDED RELEASE / ORAL		7 mg	Exact identifier — unii candidate 21 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
e51f9ed7-389f-4b5b-b9b3-5a408350a7bb			a3345cf5-5e48-4052-b5c2-65633869de5a	2012-12-28	Warnings	Exact identifier spl id: e51f9ed7-389f-4b5b-b9b3-5a408350a7bb spl set id: a3345cf5-5e48-4052-b5c2-65633869de5a

Reported adverse events (FAERS/openFDA)#

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