mark

Manufacturer: Avon Products, Inc.
Effective date: 2010-06-02
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:25:04

Label at a glance#

Productmark Totally Balmed

Active ingredientOCTINOXATE, OXYBENZONE, OCTISALATE, AVOBENZONE

Label structure6 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Uses: Helps prevent sunburn. Higher SPF gives more sunburn protection.

DOSAGE & ADMINISTRATION SECTION

Directions: Glide on lips. Apply liberally before sun
exposure and as needed.

WARNINGS SECTION

Warning: Discontinue use if skin irritation develops or increases. If irritation persists, consult a doctor.

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients:
     OCTINOXATE 7.00%
     OXYBENZONE 4.75%
     OCTISALATE 4.75%
     AVOBENZONE 2.00%

INACTIVE INGREDIENT SECTION

     RICINUS COMMUNIS (CASTOR) SEED OIL
     BEESWAX/CIRE D'ABEILLE
     HYDROGENATED VEGETABLE OIL
     EUPHORBIA CERIFERA (CANDELILLA) WAX/CIRE DE CANDELILLA
     PETROLATUM
     C10-30 CHOLESTEROL/LANOSTEROL ESTERS
     HYDROGENATED CASTOR OIL
     AROMA/FLAVOR
     ALOE BARBADENSIS LEAF EXTRACT
     SESAMUM INDICUM (SESAME) SEED OIL
     BENZOIC ACID
     ASCORBYL PALMITATE
     TOCOPHERYL ACETATE
     RETINYL PALMITATE
     SACCHARIN
     TOCOPHEROL
     TIN OXIDE

MAY CONTAIN:
       MICA/CI 77019
       TITANIUM DIOXIDE/CI 77891
       IRON OXIDES
       RED 7 LAKE
       YELLOW 5 LAKE/CI 19140
       RED 33 LAKE/CI 17200
       RED 6/CI 15850
       BLUE 1 LAKE/CI 42090
       BISMUTH OXYCHLORIDE/CI 77163
       ORANGE 5/CI 45370
       RED 21 LAKE/CI 45380
       RED 21/CI 45380
       RED 22 LAKE/CI 45380
       RED 27 LAKE/CI 45410
       RED 28 LAKE/CI 45410
       RED 30 LAKE/CI 73360
       YELLOW 10 LAKE/CI 47005
       YELLOW 6 LAKE/CI 15985
       RED 40 LAKE/CI 16035

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of cartonimage of carton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
10096-0201-2	2019-10-21	C162847	48780-1	956f9ecf-cfae-621f-e053-dbdaa90a74ad	adf84113-e046-481c-865a-c397c4694e2d

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
10096-0201-1	markTotally Balmed	4.2 g in 1 CASE	LIPSTICK	4.2		1
10096-0201-2	markTotally Balmed	1 in 1 CARTON	LIPSTICK	1		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10096-0201	MARK TOTALLY BALMED (OCTINOXATE, OXYBENZONE, OCTISALATE, AVOBENZONE ) LIPSTICK [AVON PRODUCTS, INC.]	1	Legacy NDC, 2 package rows	20100707_adf84113-e046-481c-865a-c397c4694e2d.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
AVOBENZONE	ACTIVE INGREDIENT	G63QQF2NOX	1
OCTINOXATE	ACTIVE INGREDIENT	4Y5P7MUD51	1
OCTISALATE	ACTIVE INGREDIENT	4X49Y0596W	1
OXYBENZONE	ACTIVE INGREDIENT	95OOS7VE0Y	1
AVOBENZONE	ACTIVE MOIETY	G63QQF2NOX	1
OCTINOXATE	ACTIVE MOIETY	4Y5P7MUD51	1
OCTISALATE	ACTIVE MOIETY	4X49Y0596W	1
OXYBENZONE	ACTIVE MOIETY	95OOS7VE0Y	1
ASCORBYL PALMITATE	INACTIVE INGREDIENT	QN83US2B0N	1
BENZOIC ACID	INACTIVE INGREDIENT	8SKN0B0MIM	1
BISMUTH OXYCHLORIDE	INACTIVE INGREDIENT	4ZR792I587	1
HYDROGENATED CASTOR OIL	INACTIVE INGREDIENT	ZF94AP8MEY	1
MICA	INACTIVE INGREDIENT	V8A1AW0880	1
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	1
SACCHARIN	INACTIVE INGREDIENT	FST467XS7D	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 · 14 matching rows.

mark Totally Balmed
OCTINOXATE, OXYBENZONE, OCTISALATE, AVOBENZONE
OCTINOXATE
OXYBENZONE
OCTISALATE
AVOBENZONE
PETROLATUM
HYDROGENATED CASTOR OIL
BENZOIC ACID
ASCORBYL PALMITATE
SACCHARIN
MICA
TITANIUM DIOXIDE
BISMUTH OXYCHLORIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
10096-0201	10096-0201-1, 10096-0201-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
OCTINOXATE	4Y5P7MUD51	ACTIB
OXYBENZONE	95OOS7VE0Y	ACTIB
OCTISALATE	4X49Y0596W	ACTIB
AVOBENZONE	G63QQF2NOX	ACTIB
PETROLATUM	4T6H12BN9U	IACT
HYDROGENATED CASTOR OIL	ZF94AP8MEY	IACT
BENZOIC ACID	8SKN0B0MIM	IACT
ASCORBYL PALMITATE	QN83US2B0N	IACT
SACCHARIN	FST467XS7D	IACT
MICA	V8A1AW0880	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
BISMUTH OXYCHLORIDE	4ZR792I587	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 2 · 115 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 40 equally ranked IID candidates
ASCORBYL PALMITATE	ASCORBYL PALMITATE	QN83US2B0N	SOLUTION / TOPICAL	NA		Exact identifier — unii candidate 6 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	OINTMENT / OPHTHALMIC	88.4 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	LOTION / TOPICAL	25 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	TABLET, COATED / ORAL	NA		Exact identifier — unii candidate 23 equally ranked IID candidates
SACCHARIN	SACCHARIN	FST467XS7D	TABLET / ORAL	1.6 mg		Exact identifier — unii candidate 16 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	FILM, SOLUBLE / BUCCAL		11 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	INJECTION / INTRAVENOUS	5 %w/v		Exact identifier — unii candidate 23 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, COATED / ORAL		49 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
ASCORBYL PALMITATE	ASCORBYL PALMITATE	QN83US2B0N	TABLET / ORAL	7.14 mg		Exact identifier — unii candidate 6 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	OINTMENT / TOPICAL	5 %w/w		Exact identifier — unii candidate 40 equally ranked IID candidates
SACCHARIN	SACCHARIN	FST467XS7D	SYRUP / ORAL		8 mg	Exact identifier — unii candidate 16 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	POWDER / RESPIRATORY (INHALATION)	2 mg		Exact identifier — unii candidate 40 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, FILM COATED / ORAL		36 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	CREAM / VAGINAL		10 mg	Exact identifier — unii candidate 23 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	EMULSION / TOPICAL	7.8 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	GRANULE, FOR SUSPENSION / ORAL		143 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
HYDROGENATED CASTOR OIL	HYDROGENATED CASTOR OIL	ZF94AP8MEY	TABLET / ORAL		232 mg	Exact identifier — unii candidate 12 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, LIQUID FILLED / ORAL		12 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
HYDROGENATED CASTOR OIL	HYDROGENATED CASTOR OIL	ZF94AP8MEY	TABLET, FILM COATED / ORAL		17 mg	Exact identifier — unii candidate 12 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CREAM / TOPICAL		80 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	GUM, CHEWING / BUCCAL		182 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	OINTMENT / TOPICAL		7275 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
HYDROGENATED CASTOR OIL	HYDROGENATED CASTOR OIL	ZF94AP8MEY	CAPSULE, EXTENDED RELEASE / ORAL	410.82 mg		Exact identifier — unii candidate 12 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	FILM / BUCCAL		3 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET / ORAL		232 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	OINTMENT / AURICULAR (OTIC)	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
HYDROGENATED CASTOR OIL	HYDROGENATED CASTOR OIL	ZF94AP8MEY	SUSPENSION / TOPICAL		286 mg	Exact identifier — unii candidate 12 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	SUPPOSITORY, EXTENDED RELEASE / INTRAUTERINE	1 mg		Exact identifier — unii candidate 40 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	LOTION / TOPICAL	NA		Exact identifier — unii candidate 40 equally ranked IID candidates
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	TABLET, FILM COATED / ORAL	NA		Exact identifier — unii candidate 23 equally ranked IID candidates
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	GEL / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 23 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, EXTENDED RELEASE / ORAL		90 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	SYRUP / ORAL		20 mg	Exact identifier — unii candidate 23 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	LIQUID / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
ASCORBYL PALMITATE	ASCORBYL PALMITATE	QN83US2B0N	SYSTEM / TOPICAL	0.04 mg		Exact identifier — unii candidate 6 equally ranked IID candidates
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	MOUTHWASH / BUCCAL	NA		Exact identifier — unii candidate 23 equally ranked IID candidates
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	AEROSOL, FOAM / TOPICAL		1 mg	Exact identifier — unii candidate 23 equally ranked IID candidates
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	LOTION / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 23 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, ORALLY DISINTEGRATING / ORAL		6 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	SUSPENSION / ORAL		113 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	INJECTION, SOLUTION / INTRAMUSCULAR	0.2 %w/v		Exact identifier — unii candidate 23 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, COATED / ORAL		17 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
HYDROGENATED CASTOR OIL	HYDROGENATED CASTOR OIL	ZF94AP8MEY	CAPSULE, DELAYED RELEASE / ORAL	3.1 mg		Exact identifier — unii candidate 12 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, DELAYED RELEASE PELLETS / ORAL		24 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	SUPPOSITORY / VAGINAL	2 mg		Exact identifier — unii candidate 23 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	SOAP / TOPICAL	0.85 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	SOAP / TOPICAL	1 %w/w		Exact identifier — unii candidate 40 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, DELAYED RELEASE / ORAL		55 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
SACCHARIN	SACCHARIN	FST467XS7D	AEROSOL, METERED / RESPIRATORY (INHALATION)	0.05 %w/w		Exact identifier — unii candidate 16 equally ranked IID candidates
ASCORBYL PALMITATE	ASCORBYL PALMITATE	QN83US2B0N	CAPSULE / ORAL	12 mg		Exact identifier — unii candidate 6 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	FILM, EXTENDED RELEASE / TRANSDERMAL	NA		Exact identifier — unii candidate 40 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	FILM, SOLUBLE / ORAL		2 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
HYDROGENATED CASTOR OIL	HYDROGENATED CASTOR OIL	ZF94AP8MEY	AEROSOL, FOAM / TOPICAL	2 %w/w		Exact identifier — unii candidate 12 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	CREAM, AUGMENTED / TOPICAL	26 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
ASCORBYL PALMITATE	ASCORBYL PALMITATE	QN83US2B0N	SUPPOSITORY / RECTAL		16 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	CAPSULE, EXTENDED RELEASE / ORAL	0.07 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE / ORAL		72 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
HYDROGENATED CASTOR OIL	HYDROGENATED CASTOR OIL	ZF94AP8MEY	CAPSULE / ORAL	405 mg		Exact identifier — unii candidate 12 equally ranked IID candidates
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	LIQUID / ORAL	2 mg/1ml		Exact identifier — unii candidate 23 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
1a4c6245-bd7f-450d-8d75-b1cbe2974fec			adf84113-e046-481c-865a-c397c4694e2d	2010-06-02	Warnings	Exact identifier spl id: 1a4c6245-bd7f-450d-8d75-b1cbe2974fec spl set id: adf84113-e046-481c-865a-c397c4694e2d

Reported adverse events (FAERS/openFDA)#

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