LipCoTZ

Manufacturer: Fallien Cosmeceuticals, LTD. | Process Technologies & Packaging | Custom Analytics LLC
Effective date: 2010-09-09
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:25:49

Label at a glance#

ProductLipCoTZ Lip Balm/Sunscreen

Active ingredientTitanium Dioxide, Zinc Oxide

Label structure9 sections

Indications and uses

Helps prevent sunburn; higher SPF gives more sunburn protection for skin that sunburns easily

Dosage and administration

Apply generously to lips prior to sun exposure. Reapply often and after water activity, excessive perspiration or towel drying. Children under 6 years old, consult a physician.

Contacts and useful links#

PhoneLabel contact800-332-5536

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; higher SPF gives more sunburn protection for skin that sunburns easily

Warnings:

WARNINGS SECTION

For External Use Only. Stop use and consult a physician if rash or irritation develops. Avoid contact with eyes.

Keep out of reach of children:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center.

Directions:

DOSAGE & ADMINISTRATION SECTION

Apply generously to lips prior to sun exposure. Reapply often and after water activity, excessive perspiration or towel drying. Children under 6 years old, consult a physician.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Alumina, Aluminum Hydroxide, Aluminum Stearate, Ascorbic Acid, Ascorbyl Palmitate, C12-15 Alkyl Benzoate, Cetearyl Isononanoate, Cetyl PEG/PPG-15/15 Butyl Ether Dimethicone, Citric Acid, Dipropylene Glycol Dicaprylate-Caprate, Ethylhexyl Palmitate, Flavor, Helianthus Annus (Sunflower) Seed Wax, Hexyldecanol, Hexyldecyl Laurate, Iron Oxides, Lecithin, Ozokerite, PEG-8, Polyglyceryl-3 Diisostearate, Polyhydroxy Stearic Acid, Stearic Acid, Tocopherol, Tocopheryl Acetate, Zingiber Offinale (Ginger) Root Oil

Principal Display Panel – Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 58892-125-87

SPF 45

LIPCŌTZ

Contains Only Titanium & Zinc™

SPF 45

Contains Only Titanium & Zinc™

Ultra High Sun Protection no chemical sunscreen filters

Net Wt. .14 Oz./ 4.5 g

For Information Call:

800-332-5536

Manufactured for: Fallene, Ltd

West Norriton, PA

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
c5cd4727-ac49-4409-82b1-5bd8006c3ec7	Product name	1	20171122
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
58892-125-87	2019-10-21	C162847	48780-1	956f9ecf-d188-621f-e053-dbdaa90a74ad	LIPCŌTZ

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
58892-125-87	LipCoTZ Lip Balm/Sunscreen	1 in 1 CARTON	LIPSTICK	1		1
58892-125-87	LipCoTZ Lip Balm/Sunscreen	4.5 g in 1 TUBE	LIPSTICK	4.5		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58892-125	LIPCOTZ (TITANIUM DIOXIDE, ZINC OXIDE) LIPSTICK [FALLIEN COSMECEUTICALS, LTD.]	1	Legacy NDC, 2 package rows	20100915_0d0bd849-3f96-4d7a-9ca9-7cf93f4e001b.zip

DailyMed Socrata Ingredients#

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

Products#

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

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

LipCoTZ 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
58892-125	58892-125-87

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
Stearic Acid	STEARIC ACID	4ELV7Z65AP	TABLET / BUCCAL	6 mg		Exact identifier — unii candidate 26 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	SOLUTION / OPHTHALMIC		46 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
Anhydrous Citric Acid	ANHYDROUS CITRIC ACID	XF417D3PSL	LOZENGE / TRANSMUCOSAL		44 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
Anhydrous Citric Acid	ANHYDROUS CITRIC ACID	XF417D3PSL	TABLET, CHEWABLE / ORAL		4 mg	Exact identifier — unii candidate 61 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
Aluminum Oxide	ALUMINUM OXIDE	LMI26O6933	SPONGE / TOPICAL	NA		Exact identifier — unii candidate 2 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	CREAM / TOPICAL	10 %w/w		Exact identifier — unii candidate 36 equally ranked IID candidates
Anhydrous Citric Acid	ANHYDROUS CITRIC ACID	XF417D3PSL	SYRUP / ORAL		268 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
Ascorbyl Palmitate	ASCORBYL PALMITATE	QN83US2B0N	CREAM / TOPICAL	0.02 %w/w		Exact identifier — unii candidate 6 equally ranked IID candidates
Ascorbic Acid	ASCORBIC ACID	PQ6CK8PD0R	TABLET / ORAL		80 mg	Exact identifier — unii candidate 25 equally ranked IID candidates
Ascorbic Acid	ASCORBIC ACID	PQ6CK8PD0R	SYRUP / ORAL		200 mg	Exact identifier — unii candidate 25 equally ranked IID candidates
Anhydrous Citric Acid	ANHYDROUS CITRIC ACID	XF417D3PSL	TABLET / SUBLINGUAL		36 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
Anhydrous Citric Acid	ANHYDROUS CITRIC ACID	XF417D3PSL	FILM, SOLUBLE / ORAL		7 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
Ferric Oxide Red	FERRIC OXIDE RED	1K09F3G675	TABLET / SUBLINGUAL	1 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
Anhydrous Citric Acid	ANHYDROUS CITRIC ACID	XF417D3PSL	SOLUTION / RESPIRATORY (INHALATION)		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
Stearic Acid	STEARIC ACID	4ELV7Z65AP	TABLET, COATED / ORAL	42.4 mg		Exact identifier — unii candidate 26 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	EMULSION / TOPICAL	1.2 %w/w		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
Ceresin	CERESIN	Q1LS2UJO3A	OINTMENT / TOPICAL		1097 mg	Exact identifier — unii candidate 2 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
Lecithin, Soybean	SOYBEAN LECITHIN	1DI56QDM62	POWDER, FOR SUSPENSION / ORAL		39 mg	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
Stearic Acid	STEARIC ACID	4ELV7Z65AP	CAPSULE / ORAL		90 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
Ascorbyl Palmitate	ASCORBYL PALMITATE	QN83US2B0N	TABLET / ORAL	7.14 mg		Exact identifier — unii candidate 6 equally ranked IID candidates
Stearic Acid	STEARIC ACID	4ELV7Z65AP	TABLET, CHEWABLE / ORAL		180 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
Alpha-Tocopherol	.ALPHA.-TOCOPHEROL	H4N855PNZ1	CAPSULE / ORAL		16 mg	Exact identifier — unii candidate 10 equally ranked IID candidates
Lecithin, Soybean	SOYBEAN LECITHIN	1DI56QDM62	CAPSULE / ORAL	20 mg		Exact identifier — unii candidate 7 equally ranked IID candidates
Aluminum Stearate	ALUMINUM STEARATE	U6XF9NP8HM	CREAM / TOPICAL	0.01 %w/w		Exact identifier — unii candidate 5 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	CONCENTRATE / ORAL		3000 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
Stearic Acid	STEARIC ACID	4ELV7Z65AP	TABLET, DELAYED RELEASE / ORAL		80 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
Anhydrous Citric Acid	ANHYDROUS CITRIC ACID	XF417D3PSL	SUSPENSION / RESPIRATORY (INHALATION)		1 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
Anhydrous Citric Acid	ANHYDROUS CITRIC ACID	XF417D3PSL	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS		35 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
Anhydrous Citric Acid	ANHYDROUS CITRIC ACID	XF417D3PSL	LIQUID / INTRAVENOUS		18 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	INJECTION / INTRAMUSCULAR		406 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
Stearic Acid	STEARIC ACID	4ELV7Z65AP	LOTION / TOPICAL		80 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
Ascorbic Acid	ASCORBIC ACID	PQ6CK8PD0R	INJECTION / INTRACAVITARY	5 mg		Exact identifier — unii candidate 25 equally ranked IID candidates
Ferric Oxide Red	FERRIC OXIDE RED	1K09F3G675	TABLET, FILM COATED / ORAL		3 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
Alpha-Tocopherol	.ALPHA.-TOCOPHEROL	H4N855PNZ1	OINTMENT / TOPICAL	NA		Exact identifier — unii candidate 10 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	SYSTEM / TOPICAL	0.1 mg		Exact identifier — unii candidate 10 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		2 mg	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
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	FILM, SOLUBLE / ORAL		29 mg	Exact identifier — unii candidate 36 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
Anhydrous Citric Acid	ANHYDROUS CITRIC ACID	XF417D3PSL	POWDER, FOR SOLUTION / ORAL		123 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
Anhydrous Citric Acid	ANHYDROUS CITRIC ACID	XF417D3PSL	SUSPENSION / RECTAL		904 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
Ascorbic Acid	ASCORBIC ACID	PQ6CK8PD0R	SOLUTION / ORAL		600 mg	Exact identifier — unii candidate 25 equally ranked IID candidates
Ferric Oxide Red	FERRIC OXIDE RED	1K09F3G675	TABLET, ORALLY DISINTEGRATING / ORAL		2 mg	Exact identifier — unii candidate 21 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
Ascorbyl Palmitate	ASCORBYL PALMITATE	QN83US2B0N	CAPSULE / ORAL	12 mg		Exact identifier — unii candidate 6 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
Anhydrous Citric Acid	ANHYDROUS CITRIC ACID	XF417D3PSL	SPRAY / TOPICAL	0.01 %w/w		Exact identifier — unii candidate 61 equally ranked IID candidates
Aluminum Stearate	ALUMINUM STEARATE	U6XF9NP8HM	TABLET, EXTENDED RELEASE / ORAL	105 mg		Exact identifier — unii candidate 5 equally ranked IID candidates
Alpha-Tocopherol	.ALPHA.-TOCOPHEROL	H4N855PNZ1	INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS	0.64 mg		Exact identifier — unii candidate 10 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
Ferric Oxide Red	FERRIC OXIDE RED	1K09F3G675	LOTION / TOPICAL	NA		Exact identifier — unii candidate 21 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	LIQUID / TOPICAL	1 %w/w		Exact identifier — unii candidate 36 equally ranked IID candidates
Lecithin, Soybean	SOYBEAN LECITHIN	1DI56QDM62	CREAM / VAGINAL	1 %w/w		Exact identifier — unii candidate 7 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
5d4a9076-4a63-4ea3-8776-802e06fba806			0d0bd849-3f96-4d7a-9ca9-7cf93f4e001b	2010-09-09	Warnings	Exact identifier spl id: 5d4a9076-4a63-4ea3-8776-802e06fba806 spl set id: 0d0bd849-3f96-4d7a-9ca9-7cf93f4e001b

Reported adverse events (FAERS/openFDA)#

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